This page shows what was measured, who it was measured in, and what that does not settle.
What Denosumab does in the body
Postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors fo
From the FDA-approved label: Denosumab products bind to RANKL, a transmembrane or soluble protein essential for the formation, function, and survival of osteoclasts, the cells responsible for bone resorption, thereby modulating calcium release from bone. Increased osteoclast activity, stimulated by RANKL, is a mediator of bone pathology in solid tumors with osseous metastases. Similarly, giant cell tumors of bone consist of stromal cells expressing RANKL and osteoclast-like giant cells expressing RANK receptor, and signaling through the RANK receptor contributes to osteolysis and tumor growth.
What happened in people
RNAWiki has not yet published a reviewed conclusion for this use.
§ A fixed RNAWiki sentence
Where this came from
Wording RNAWiki always uses, not a finding about this substance.
No reviewed claim names a result for any goal on this record.
No source is stored against this line.
The limit that matters most
Not recorded.
Where it acts
Not recorded.
Kind of result
No result is published, so no kind of result applies yet
Supervision
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.
What the registries record it as
The substance registry classes this as protein.
FDA substance registry · 4EQZ6YO2HI · read 2026-08-29
Where each sentence above came from
No recorded sentence describes the change this makes in a way that stands on its own. The page opens with what it is taken for instead, and the recorded explanation follows below.
Shown as the opening line on this page.
No statement of the main limit is recorded.
The four opening statements run to 118 words.
Words this page uses
Four words worth knowing first
Chosen from what this page shows, with each one explained before the word it depends on.
Stand-in result
A stand-in result is a number measured because the real result takes too long.
A picture of it, and where the picture fails
It is like judging a journey by the speedometer rather than by arriving.
Where that stops being true. Speed does predict arrival. Many stand-in results do not predict the real one.
What people get wrong. A stand-in result is often reported as the result itself.
A surrogate endpoint substituted for a clinical endpoint, valid only where the substitution has been shown to hold.
Enzyme
An enzyme is a protein that speeds up one chemical change.
A picture of it, and where the picture fails
An enzyme is like a machine on a production line doing one cut.
Where that stops being true. A machine is switched on and off by a person. Enzymes are controlled by the cell.
What people get wrong. Enzymes are thought to be used up. They are not; they work again and again.
A catalytic protein that lowers the activation energy of a specific reaction.
Receptor
A receptor is a part of a cell that a signal fits into.
A picture of it, and where the picture fails
A receptor is like a lock waiting for one key.
Where that stops being true. A lock either opens or does not. A receptor can be half-triggered, or worn out.
What people get wrong. Fitting a receptor is read as causing a benefit. It causes a step, and nothing more.
A protein that binds a specific ligand and converts that binding into a cellular response.
Pathway
A pathway is a chain of steps inside a cell, each one setting off the next.
A picture of it, and where the picture fails
A pathway is like a row of dominoes.
Where that stops being true. Dominoes fall one way. Pathways loop back and can switch themselves off.
What people get wrong. Changing one step is read as changing the outcome. Other steps often absorb it.
An ordered series of molecular interactions producing a defined cellular change.
What happened in people◇Read from sources, not yet reviewed
What happened in people
Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.
Number of Participants With New Vertebral Fractures
✗ The study did not show it
Who was studied
NCT00089791
How many people
7808
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Subcutaneous
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
Percentage of Participants With New Vertebral Fracture Through Month 12
✗ The study did not show it
Who was studied
NCT01575834
How many people
7180
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Subcutaneous
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
Number of Participants With Adverse Events (AEs)
✗ The study did not show it
Who was studied
NCT00523341
How many people
4550
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Subcutaneous
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
Bone Metastasis-free Survival (BMFS)
✗ The study did not show it
Who was studied
NCT01077154
How many people
4509
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Subcutaneous
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
Time to First Clinical Fracture
✗ The study did not show it
Who was studied
NCT00556374
How many people
3420
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Subcutaneous
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
Number of Participants That Initiate an Osteoporosis Prescription Medication
✗ The study did not show it
Who was studied
NCT01907269
How many people
2684
Study design
Not applicable
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Subcutaneous
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
What we know
RNAWiki holds 6 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.
What happened in people◇Read from sources, not yet reviewed
How close this is to real life
The top step is something a person would feel or care about. The bottom is a guess from software. Filled steps are where evidence exists for this substance.
■Living longer, or avoiding a major eventEvidence recorded. Death, a heart attack, a stroke, a hospital stay.4 registered measures of this kind. 1 written-up study measured this and did not show a benefit.
□What a body can do day to dayNo evidence recorded. Walking, dressing, breathing, recovering.No registered study measures this.
□Measured performanceNo evidence recorded. How much was lifted, how far was run, how fast.No registered study measures this.
□Symptoms and quality of lifeNo evidence recorded. Pain, tiredness, mood, sleep, as the person rated it.No registered study measures this.
■A number that stands in for healthEvidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.11 registered measures of this kind.
■A step measured inside a personEvidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
■AnimalsEvidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.Stored records in Rat. A result in animals says what to test next. It does not say what happens in people.
■Cells in a dishEvidence recorded. Cells or chemistry on a bench, far from a whole body.Stored mechanism abstracts describe steps measured in cells or tissue.
□A guess from softwareNo evidence recorded. Nobody measured it. RNAWiki never publishes one as a finding.RNAWiki stores no prediction for this record. Software can suggest a link. RNAWiki does not publish one as a finding.
Higher on these steps means closer to something a person would feel. It does not mean better done.
What it would be like to take◇Read from sources, not yet reviewed
Felt, measured, or meaningful
Three different things that get called the same word. Registered studies measured all three, and mixing them is how a blood test becomes a health claim.
Felt
Things a person could notice without a test.
No registered study measured anything of this kind.
Measured
Things only a test, a scale or a device shows.
total hip bone mineral density
maximum observed serum concentration of etanercept
bone mineral density at the lumbar spine
bone mineral density
bone mineral density at the lumbar spine at month 12
spine bone mineral density by dual x ray absorptiometry
bone mineral density of the lumbar spine
bone mineral density at lumbar spine
lumbar spine bone mineral density
femoral neck bone mineral density
and 1 more.
Meaningful
Things that change how a life goes, not only a number.
bone metastasis free survival
time to first clinical fracture
overall survival
progression free survival
A registered study says what someone planned to measure. It does not say what they found. A number moving is not the same as a life going better. The two are shown apart here.
Felt, but not shown to help. A person notices a change. No study showed it leads anywhere good.
Measured, but not felt. A number moves. The person notices nothing. Both can be true.
Measured, but not shown to matter. A number moves in the good direction. Nobody showed that lives went better.
Matters, but takes years. The result that counts may take longer than anyone would keep watching.
Names that fit none of the three (25)
new vertebral fractures
time to first on study skeletal related event
time to the first on study sre
time to the first on study skeletal related event
giant cell tumor response
adverse events
treatment emergent adverse events
at month 12 in bmd at the lumbar spine
spine bone density from baseline to 2 years
an on study skeletal related event
sclerostin
maximum tolerated dose of everolimus
incidence of adverse events
bone turnover marker
laboratory values
aortic valve calcium
lumbar spine bmd
osteoporosis that are appropriately treated
disease response
trabecular bone
These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.
What it would be like to take◇Read from sources, not yet reviewed
How long anything takes
Nine different lengths of time that get confused with each other. None of them is worked out from another.
Before anything is noticed.RNAWiki does not store this separately, and never works it out from another figure on this page.
Before a test result moves.RNAWiki does not store this separately, and never works it out from another figure on this page.
Before performance moves.RNAWiki does not store this separately, and never works it out from another figure on this page.
How long the result was watched.No finished study window is recorded for a study that tested this substance.
How long people took it.How long people actually took it is not stored. The study window is not the same thing.
How long people were followed.Follow-up length is not stored separately. It is never read off the study window, which would be a different thing.
How fast the body clears it. 25.4 days
Read from the label, which states: “Elimination Serum denosumab concentrations declined over a period of 4 to 5 months with a mean half-life of 25.4 days (SD = 8.5 days; n = 46).”
How long effects linger.RNAWiki does not store this separately, and never works it out from another figure on this page.
Beyond the studies. Nothing is recorded about the long term.
The longest finished study sets the edge of what anyone measured.
A study window is not how long people took it, and neither is how long they were followed. Where RNAWiki holds only one of the three, it shows one.
What is missing or unclear◇Read from sources, not yet reviewed
Were people like you studied?
RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.
Who was studied
People similar to this profile were included.
Ospomyv is a RANK ligand (RANKL) inhibitor indicated for treatment: of postmenopausal women with osteoporosis at high risk for fracture ( 1.1 ) to increase bone mass in men with osteoporosis at high risk for fracture ( 1.2 ) of glucocorticoid-induced osteoporosis in men and women at high risk for fracture ( 1.3 ) to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for…
Who is missing from the studies
Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What the label states about particular groups
On pediatric, the label states: “The safety and effectiveness of Ospomyv have not been established in pediatric patients.”
US prescribing information · e1d80a82-de52-4a34-9df3-609e50667ffb · read 2026-08-30
On older people, the label states: “Of the total number of patients in clinical studies of denosumab, 9943 patients (76%) were ≥ 65 years old, while 3576 (27%) were ≥ 75 years old.”
US prescribing information · e1d80a82-de52-4a34-9df3-609e50667ffb · read 2026-08-30
On people who are pregnant, the label states: “Data Animal Data The effects of denosumab on prenatal development have been studied in both cynomolgus monkeys and genetically engineered mice in which RANK ligand (RANKL) expression was turned off by gene removal (a "knockout mouse").”
US prescribing information · e1d80a82-de52-4a34-9df3-609e50667ffb · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary There is no information regarding the presence of denosumab products in human milk, the effects on the breastfed infant, or the effects on milk production.”
US prescribing information · e1d80a82-de52-4a34-9df3-609e50667ffb · read 2026-08-30
On people with reduced kidney function, the label states: “No dose adjustment is necessary in patients with renal impairment.”
US prescribing information · e1d80a82-de52-4a34-9df3-609e50667ffb · read 2026-08-30
Where the result stopped carrying
This is a scope explorer, not a diagnosis engine.
It shows who was studied so you can see whether people similar to you were included.
RNAWiki cannot tell whether a study fits you. It can show who was in it.
What it would be like to take◇Read from sources, not yet reviewed
Why it might seem to do nothing
A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.
It was studied for a different goal
The studies measured something else entirely.
On this record: Some registered studies measured things that match no goal on this page.
It was studied in different people
The people in the studies were not much like the reader.
On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
The evidence may simply be wrong
Small early studies often do not hold up.
On this record: RNAWiki has not yet published a reviewed conclusion for this use.
Other reasons RNAWiki checked and found nothing for (10)
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.
None of these is a reason to take more. Taking more is not a step this page ever suggests.
What it would be like to take◇Read from sources, not yet reviewed
What taking it involves
The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.
How it is supplied
Given by a clinician
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Read from the recorded approval status.
No source is stored against this line.
Form and route
Subcutaneous
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form and route recorded on this substance.
No source is stored against this line.
Who oversees it
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Suppression classes recorded: S3, S6.
No source is stored against this line.
What is in the pack
Sold as injectable, injection, injection, solution, given by the subcutaneous route.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on how this is sold and what that means for what is in the pack.
No source is stored against this line.
Where it is registered
Regulatory records are listed in the technical disclosure at the foot of this page.
# Counted from records
Where this came from
A count of rows RNAWiki holds. It describes our records, not your body.
Register entries are stored per jurisdiction and shown with their dates.
No source is stored against this line.
Why people stop
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
No record of why people stopped taking it is stored for this substance.
No source is stored against this line.
What it would be like to take∅Nothing found in the sources checked
What can go wrong
Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.
∅Nothing found in the sources checked
No harm is recorded against this substance in the sources RNAWiki checked. Finding nothing is not the same as showing there is nothing.
The sources listed were searched and held nothing. That is not the same as nothing existing.
Reports sent to a regulator
These are reports people sent to a regulator. They do not show the medicine caused the reaction.
Nobody counted how many people took the medicine and reported nothing.
The same event can be reported more than once, and many reports are incomplete.
News coverage, lawsuits and new warnings change how often people report.
A count is not a rate and not a risk.
Denosumab appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 23274 reaction mentions were counted. One report can name several reactions.
The recorded terms (10)
osteonecrosis of jaw — 5511 reaction mentions
arthralgia — 3283 reaction mentions
pain in extremity — 2730 reaction mentions
back pain — 2455 reaction mentions
myalgia — 1775 reaction mentions
hypocalcaemia — 1765 reaction mentions
bone pain — 1689 reaction mentions
tooth disorder — 1476 reaction mentions
spinal fracture — 1327 reaction mentions
pain in jaw — 1263 reaction mentions
open-targets-adr · recorded 2026-06-24 · a recorded source, not a stored snapshot
Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.
Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What is missing or unclear◇Read from sources, not yet reviewed
Does the exact form matter?
Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.
The form that was studied
Subcutaneous
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form used in the studies cited on this page.
No source is stored against this line.
What is sold
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
Nothing further is recorded about which forms are sold.
No source is stored against this line.
What is recorded as being sold
25 products list this as an active ingredient in the United States drug directory. 25 of them contain it and nothing else.
FDA National Drug Code directory · 83457-012 · read 2026-08-29
They are sold as injection, injection, solution and liquid, taken subcutaneous.
FDA National Drug Code directory · 83457-012 · read 2026-08-29
The regulator's established pharmacologic class for it is rank ligand blocking activity [moa] and rank ligand inhibitor [epc].
FDA National Drug Code directory · 83457-012 · read 2026-08-29
21 published labels name it as an active ingredient. 21 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · b1f0590e-f5bb-44ac-99a0-4aa4596c7e54 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · b1f0590e-f5bb-44ac-99a0-4aa4596c7e54 · read 2026-08-29
OSPOMYV is subcutaneous at 3 DOSAGE FORMS AND STRENGTHS Injection: 60 mg/mL clear, colorless to slightly yellow solution in a single-dose prefilled syringe., recorded as fda label in effect 2025-11-11 in the United States.
US prescribing information · e1d80a82-de52-4a34-9df3-609e50667ffb · read 2026-08-30
Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.
What it would be like to take◇Read from sources, not yet reviewed
What you could measure
This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.
Self-experiment planning is not offered for a prescription or clinician-supervised medicine. The questions below are for a clinician or pharmacist.
Questions worth asking
Which of the trials of Denosumab studied people like me?
What was measured, and for how long?
Was the result a laboratory value or a health outcome?
What would we watch for, and when would we stop?
Tracking can show whether something changed for you. It cannot show what caused it.
RNAWiki records evidence. It does not say whether this substance is right for you.
What is missing or unclear◇Read from sources, not yet reviewed
What nobody knows yet
Open questions, each with why it is open and what would close it.
Missing populations
Which groups were under-represented in the studies has not been recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing long-term data
No completed tested study window is recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
No reviewed conclusion
RNAWiki has not yet published a reviewed conclusion for this use.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing interaction studies
No interaction was found in the registers checked. Not finding one is not the same as showing there is none.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Formulation uncertainty
Several salts, forms or products of Denosumab are recorded. Results from one form may not transfer to another.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Mechanism not reviewed
No reviewed mechanism story exists for this substance.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
What happened in people◇Read from sources, not yet reviewed
Check any of this yourself
Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.
How many documents were read
9 documents were read for this substance.
RNAWiki source record
4 of them state the same bioavailability, and they agree.
RNAWiki source record
5 of them state the same volumeOfDistribution, and they agree.
RNAWiki source record
Where else this substance is registered
FDA substance identifier (UNII)
4EQZ6YO2HI
RxNorm concept
2723338
Checks this page had to pass
✓ Passed
Identity resolved
no open identity hold
✓ Passed
No unresolved merge across substance families
no quarantine open
✓ Passed
Every public sentence names a source
The opening statement carries the origin: Written into the record, not signed off.
✗ Not passed
Trial roles classified for highlighted evidence
No registered study is classified as testing this substance.
✓ Passed
No internal keys in reader text
enforced by the copy-contract test over the rendered page
✓ Passed
Safety mode resolved
Suppression classes recorded: S3, S6.
✓ Passed
Canonical metadata present
slug and display name present
What is missing or unclear◇Read from sources, not yet reviewed
How this medicine reached us
Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.
What the approval register records
1 approved application covers products containing this substance. The earliest was BLA125320, approved 20100601 to AMGEN.
This order is fixed in code and does not count clicks or time on the page.
What is not here
6 questions this page could not answer
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Recorded evidence blocks (14)
Q2
What did Denosumab's largest trial (517991 people) and its longest (16 years) measure?
517991 people in Denosumab's largest registered study, 16 years in its longest registered window, measuring Sarcopenia-related Primary Outcome. ClinicalTrials.gov · 2026-09-01
73 phase3, 71 phase2, 48 phase4, 39 phase1, 13 na or unstated, 9 na, 4 early phase1; NCT00556374; 2022-07-26. Last human test completed 2026, NCT05493761.
Interpretation These counts include studies where Denosumab was a comparison treatment, a background treatment or an exposure in an observational study, and the longest window may be a planned end date. Trial roles have not yet been classified for this record.
Show the evidence
phase3
73
phase2
71
phase4
48
phase1
39
na or unstated
13
na
9
2 more recorded rows
early phase1
4
Last recorded human testNCT05493761
2026-07-16
recorded 2026-09-01 · last checked 2026-09-04
Q3
From rat to human: where has Denosumab shown healthspan?
28 of Denosumab's trials stopped: safety, accrual/recruitment, funding/business, other?
safety (3), accrual/recruitment (14), funding/business (3) and other (8): Denosumab's stop wording, clustered. ClinicalTrials.gov · 2026-09-01
"Terminated: Amgen decision following Primary Analysis. Not due to safety reason"; 28 of 246 registered studies
Show the evidence
Trial
NCT01077154
terminated; "Terminated: Amgen decision following Primary Analysis. Not due to safety reason"
NCT01294397
terminated; "Lack of enrollment."
NCT01545648
terminated; "Low Accrual"
NCT01558115
terminated; "Poor enrollment"
NCT01734824
suspended; "no patients randomized"
NCT01864798
terminated; "Poor recruitment"
14 further recorded trials
NCT02129699
terminated; "Completion of recruitment was not feasible as accrual was slower than anticipated. Even if a benefit for denosumab could be shown, these results would be of very limited clinical impact by the time they would be available"
NCT02352753
terminated; "The study was stopped earlier than planned due to safety concerns about high levels of calcium in the blood of the participants"
NCT02418273
withdrawn; "was not funded"
NCT02444585
withdrawn; "No participants enrolled in the trial"
NCT02677246
withdrawn; "lack of funding"
NCT02758132
terminated; "Low accruals"
NCT02792413
terminated; "Modified study and new deposit in RECHMPL21\_0451"
NCT03029442
terminated; "Study ended early due to COVID-19"
NCT03040765
terminated; "failed to recruit eligible subjects"
NCT03070002
terminated; "Low accrual"
NCT03382574
terminated; "it was decided that due to lack of accrual on the trial, and low potential for accruing over the near future, the trial will be shut down."
NCT03408652
terminated; "lack of recruitment"
NCT03457818
terminated; "Due to enrollment difficulties compounded by the COVID pandemic."
NCT03532087
withdrawn; "Due to new insights"
recorded 2026-09-01 · last checked 2026-09-04
Q5
Human studies of Denosumab used 100 mg AMG 162 — over how long?
17 recorded entries; human; also "100 mg AMG 162", "60 mg AMG 162", "14 mg AMG 162"
Show the evidence
human
NCT00306189
100 mg AMG 162
NCT00306189
60 mg AMG 162
NCT00306189
14 mg AMG 162
NCT00980174
60 mg denosumab
NCT02135640
denosumab 60mg
NCT02135640
denosumab 120 mg
11 more recorded rows
humanNCT03027557
Denosumab Inj 60 mg/ml
humanNCT03040765
Denosumab 60 MG/ML Prefilled Syringe
humanNCT03270020
Denosumab 70 MG/ML [Xgeva]
humanNCT03457818
Denosumab 60 mg/ml [Prolia]
humanNCT03532087
Denosumab 120 mg
humanNCT03532087
Denosumab 60 mg
humanNCT03620149
Denosumab 120 MG/1.7 ML Subcutaneous Solution [XGEVA]
humanNCT04085419
Denosumab 60 MG/ML Prefilled Syringe [Prolia]
humanNCT04608630
Denosumab 60 MG/ML
humanNCT05096195
Denosumab 60 mg/ml
humanNCT05966064
Denosumab 120 Mg/1.7 Ml Inj
recorded 2026-09-01 · last checked 2026-09-04
Q6
Denosumab's half-life is 25.4 days — which schedules were studied?
25.4 days, the half-life Denosumab's label states. openfda-label · b1f0590e-f5bb-44ac-99a0-4aa4596c7e54 · 2026-08-30
Show the evidence
half life
25.4 days; Elimination Serum denosumab concentrations declined over a period of 4 to 5 months with a mean half-life of 25.4 days (SD = 8.5 days; n = 46).
recorded 2026-08-30 · last checked 2026-09-04
Q7
Which of 1/3 forearm bone mineral density, adverse events and an on study skeletal related event did Denosumab's trials measure?
1/3 forearm bone mineral density, adverse events and an on study skeletal related event lead 40 outcome terms across Denosumab's trials. ClinicalTrials.gov · 2026-09-01
Interpretation time to the first on study sre, time to the first on study skeletal related event, total hip bone mineral density, giant cell tumor response, adverse events and time to first clinical fracture follow.
Show the evidence
new vertebral fractures
1
bone metastasis free survival
1
time to first on study skeletal related event
1
time to the first on study sre
1
time to the first on study skeletal related event
1
total hip bone mineral density
1
14 more recorded rows
giant cell tumor response
1
adverse events
1
time to first clinical fracture
1
treatment emergent adverse events
1
at month 12 in bmd at the lumbar spine
1
spine bone density from baseline to 2 years
1
maximum observed serum concentration of etanercept
1
an on study skeletal related event
1
bone mineral density at the lumbar spine
1
sclerostin
1
maximum tolerated dose of everolimus
1
incidence of adverse events
1
bone mineral density
1
bone turnover marker
1
recorded 2026-09-01 · last checked 2026-09-04
Q8
Which of Denosumab's 43 ongoing trials reports first?
Time to first on-trial symptomatic skeletal event (SSE; Clinically significant pathological fracture, radiation therapy to bone, surgery to bone or spinal cord compression).; percentage change in the bone mineral density (BMD) for the lumbar vertebrae (L1-L4) on dual-energy X-ray absorptiometry (DXA); latest 2033-12
Show the evidence
Trial
NCT02051218
"Prevention of Symptomatic Skeletal Events With Denosumab Administered Every 4 Weeks Versus Every 12 Weeks"; n 1380; "Time to first on-trial symptomatic skeletal event (SSE; Clinically significant pathological fracture, radiation therapy to bone, surgery to bone or spinal cord compression)."; 2028-12-31
NCT03324932
"Efficacy of Denosumab on Normal BMD in Women Receiving Adjuvant Aromatase Inhibitors for Early Breast Cancer"; n 160; "percentage change in the bone mineral density (BMD) for the lumbar vertebrae (L1-L4) on dual-energy X-ray absorptiometry (DXA)"; 2027-12
NCT03571191
"Denosumab Treatment for Fibrous Dysplasia"; n 9; "Primary:1. Assessment of markers of bone turnover: Beta-crosslaps, C-telopeptides (bone resorption marker,Procollagen-1-propeptide (bone formation marker)"; 2030-03-15
NCT03623633
"Comparative Antiresorptive Efficacy Discontinuation of Denosumab"; n 51; "Serum c-telopeptide (CTX)"; 2023-08-01
NCT03921060
"Markers of Osteoporosis in Cystic Fibrosis"; n 100; "DEXA results"; 2027-07
NCT04067726
"RANKL Inhibition and Mammographic Breast Density"; n 210; "Change in mammographic breast density between the two arms as measured by volumetric percent density"; 2026-08-31
14 further recorded trials
NCT04232657
"Romosozumab to Improve Bone Mineral Density and Architecture in Chronic SCI"; n 36; "Change in vBMD at the Distal Femur, measured by pQCT after 12 months of romosozumab treatment"; 2027-03-01
NCT04467983
"Abaloparatide Added to Ongoing Denosumab vs Continued Denosumab Alone"; n 70; "Bone mineral density changes at total hip and lumbar spine"; 2026-12-01
NCT04547348
"The DENOCHARCOT Trial"; n 38; "Time until remission"; 2026-10-01
NCT04549207
"Comparing Continuation or De-escalation of Bone Modifying Agents (BMA) in Patients Treated for Over 2 Years for Bone Metastases From Either Breast or Castration-resistant Prostate Cancer"; n 240; "Health related quality of life scores"; 2026-09
NCT04586660
"Study of XGEVA® (Denosumab) in Chinese Adults and Skeletally Mature Adolescents With Giant Cell Tumor of the Bone"; n 36; "Objective tumor response"; 2028-03-07
NCT04608630
"Bone Loss Prevention With Zoledronic Acid or Denosumab in Critically Ill Adults"; n 450; "Annualised change in femoral neck bone mineral density for the year after Intensive Care discharge"; 2027-02-28
NCT04711109
"Studying the Effect of Denosumab on Preventing Breast Cancer in Women With a BRCA1 Germline Mutation"; n 300; "Time to the occurrence of any breast cancer (invasive or ductal carcinoma in situ [DCIS])"; 2033-12
NCT04800367
"Romosozumab/Denosumab Study for Premenopausal IOP"; n 30; "Percent change in lumbar spine BMD by DXA"; 2028-03
NCT05010590
"Anabolic Therapy in Postmenopausal Osteoporosis"; n 50; "Total hip areal bone mineral density"; 2027-11-01
NCT05096195
"PRevEnting FracturEs in REnal Disease - 1"; n 60; "Recruitment rate"; 2025-12
NCT05101018
"Treatment With Romosozumab Versus Denosumab to Improve Bone Mineral Density and Architecture in Subacute SCI"; n 40; "Bone mineral density (BMD) of the distal femur metaphysis"; 2027-11-01
NCT05212337
"FITMI - First In Treating Male Infertility"; n 180; "The difference in sperm concentration (million pr. mL) on day 80"; 2025-09-30
NCT05666310
"Muscle Impact of Treating Osteoporosis"; n 20; "Percentage change from baseline in muscle mass (kg) measured by D3-Creatine"; 2026-09-05
NCT05813665
"A Study to Evaluate the Efficacy and Safety of Narlumosbart (JMT103) in Patients With Giant Cell Tumor of Bone"; n 146; "Percentage of Patients With Giant Cell Objective Tumor Response"; 2028-09
recorded 2026-09-01 · last checked 2026-09-04
Q9
Which running trial of Denosumab could settle insulin sensitivity?
NCT07271771 measures Insulin sensitivity: HbA1c, reading out 2027-03-01.
3 open trials; n 40; "The Effect of Denosumab on Muscle and Strength and Insulin Sensitivity"
Show the evidence
Trial
NCT07271771
"The Effect of Denosumab on Muscle and Strength and Insulin Sensitivity"; n 40; "Insulin sensitivity: HbA1c"; 2027-03-01
NCT06749886
"An Exploratory Study of Tislelizumab in Combination with Chemotherapy in Immuno-experienced Patients with EGFR/ALK/ROS1-negative Advanced NSCLC in the Second-line Setting"; n 22; "progress free survival"; 2027-06-30
NCT07537972
"Denosumab Strategy for Liver Cancer With Bone Metastases"; n 50; "Skeletal-Related Event-Free Survival"; 2029-06-30
Q10
Which 51 trials of Denosumab posted no result?
Posted no result
51 of 51 completed trials
Registrations
NCT01572545, NCT01465568, NCT01770106, NCT01978483, NCT01799798 and NCT02135640, and 45 more
Completion dates
oldest 2013-01; newest 2024-07-05
Show the evidence
Trial
NCT01572545
2013-01
NCT01465568
2014-06
NCT01770106
2014-06
NCT01978483
2014-06
NCT01799798
2015-01
NCT02135640
2015-02-17
14 further recorded trials
NCT02760979
2015-06
NCT02853539
2016-07
NCT05736640
2016-09-30
NCT02554695
2016-10-25
NCT02996734
2016-12
NCT01630941
2017-03-30
NCT02559648
2017-12
NCT03415477
2017-12-31
NCT02321280
2018-04-20
NCT02347865
2018-09-27
NCT02499237
2018-11-26
NCT03629717
2018-12-03
NCT02422108
2019-01
NCT02239523
2019-02-28
Q11
At the median, Denosumab's trials enrolled 90 people — anything larger?
Median enrolment
90
Largest enrolment
517991
Registered trials counted
246
Q12
What do 23274 spontaneous reports say about Denosumab — and not say?
These are reports people sent to a regulator. They do not show the medicine caused the reaction. Nobody counted how many people took the medicine and reported nothing. The same event can be reported more than once, and many reports are incomplete. News coverage, lawsuits and new warnings change how often people report. A count is not a rate and not a risk.
Denosumab appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 23274 reaction mentions were counted: osteonecrosis of jaw 5511; arthralgia 3283; pain in extremity 2730; back pain 2455. open-targets-adr · CHEMBL1237023 · 2026-06-24
Show the evidence
osteonecrosis of jaw
5511
arthralgia
3283
pain in extremity
2730
back pain
2455
myalgia
1775
hypocalcaemia
1765
4 more recorded rows
bone pain
1689
tooth disorder
1476
spinal fracture
1327
pain in jaw
1263
recorded 2026-06-24 · last checked 2026-09-04
Q13
Denosumab and CYP3A4: shared by which compounds?
CYP3A4 appear in Denosumab's recorded interaction sentences, 2 in all. openfda-label+europepmc · 2026-08-30
Interpretation pharmacokinetics
Show the evidence
CYP3A4
pharmacokinetics
Denosumab did not affect the pharmacokinetics of midazolam, which is metabolized by cytochrome P450 3A4 (CYP3A4).
pharmacokinetics
This indicates that denosumab products should not alter the pharmacokinetics of drugs metabolized by CYP3A4 in postmenopausal women with osteoporosis.
recorded 2026-08-30 · last checked 2026-09-04
Q14
Was Denosumab studied with fasting and exercise?
fasting and exercise are named in Denosumab's label sentences: "We tested whether antiresorptive therapies result in higher fasting glucose, increased weight, or greater diabetes incidence in post hoc analyses of three randomized, placebo-controlled trials in postmenopausal women: Fracture Intervention Trial (FIT) (N = 6151) of alendronate (4 years), Health…" openfda-label+europepmc · 2026-08-30
2 recorded statements; fasting, exercise
Show the evidence
fasting
We tested whether antiresorptive therapies result in higher fasting glucose, increased weight, or greater diabetes incidence in post hoc analyses of three randomized, placebo-controlled trials in postmenopausal women: Fracture Intervention Trial (FIT) (N = 6151) of alendronate (4 years), Health Outcomes and Reduced Incidence with Zoledronic Acid Once Yearly Pivotal Fracture Trial (HORIZON-PFT) (N…
exercise
Randomized trials have found value in treatments for some adverse effects including bone loss (bisphosphonates, denosumab, selective estrogen receptor modulators), markers of metabolic syndrome (exercise, diet, metformin), gynecomastia (tamoxifen, prophylactic radiation), muscle loss (resistance and aerobic exercise), and hot flashes (venlafaxine, medroxyprogesterone, cyproterone acetate,…
recorded 2026-08-30 · last checked 2026-09-04
Q15
What is recorded about Denosumab and autophagy?
"Autophagic flux assays revealed p62 modulation to be dependent on autophagy following denosumab incubation." — where Denosumab and autophagy appear together. Europe PMC · pathway abstract search · 2024-01-01
autophagy, mTOR; PMID 37961860, 32320927
Show the evidence
autophagy
PMID 37961860
"Autophagic flux assays revealed p62 modulation to be dependent on autophagy following denosumab incubation."
"The two major axes include (i) identification of subgroups of tumors with druggable alteration irrespective of the histological diagnosis (e.g. NTRK), and (ii) druggable target of pathway related to the physiopathology of the tumor: denosumab and bone giant cell tumor, imatinib and soft tissue giant cell tumor, mTOR inhibitor and PECOMA."
recorded 2024-01-01 · last checked 2026-09-04
Where it is registeredIdentifiers, relations and other names
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