This page shows what was measured, who it was measured in, and what that does not settle.
What Romosozumab does in the body
Cells buried inside bone release a molecule that tells the surface to stop building.
This drug is an antibody that mops that molecule up. With the brake off, the building cells work harder for several months, and unusually the demolition side slows at the same time — every other bone drug does one or the other. The effect fades over the year as the body adjusts, which is why the course is fixed at twelve months.
Why people take it. Severe bone thinning in women at high risk of breaking a bone, treated for one year only
What happened in people
Three loss-of-function SOST mutations in sclerosteosis, producing lifelong excess bone formation
✎ 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 recorded finding that sits closest to something a person would notice. Written into the record, not signed off, and it carries no population or interval.
0.5% against 1.8% at 12 months (73% lower, P<0.001); 0.6% against 2.5% at 24 months (75% lower, P<0.001)
Repeated elsewhere
Partially Replicated
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
The limits of this study, and where it came from
Main limit. Non-vertebral fracture, a secondary endpoint, was 1.6% against 2.1% with P=0.10 — not significant. One atypical femoral fracture and two cases of osteonecrosis of the jaw occurred in the romosozumab group.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Subcutaneous injection, 210 mg monthly as two 105 mg prefilled syringes, for 12 doses
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
Co-primary: new vertebral fracture at 24 months, and clinical fracture at the primary analysis
✓ The study showed what it set out to show
Who was studied
ARCH (NCT01631214)
How many people
4093
Study design
Phase 3, randomised, double-blind, active-controlled against alendronate
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Vertebral 6.2% against 11.9% (48% lower, P<0.001); clinical 9.7% against 13.0% (27% lower, P<0.001); hip 2.0% against 3.2% (P=0.02)
Repeated elsewhere
Unreplicated
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
The limits of this study, and where it came from
Main limit. Positively adjudicated serious cardiovascular adverse events in year 1 were 50 of 2040 (2.5%) against 38 of 2014 (1.9%). This imbalance became the boxed warning and delayed approval by nearly two years.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Subcutaneous injection, 210 mg monthly as two 105 mg prefilled syringes, for 12 doses
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
Percentage change from baseline in lumbar spine bone mineral density at month 12
✓ The study showed what it set out to show
Who was studied
BRIDGE (NCT02186171)
How many people
245
Study design
Phase 3, randomised, double-blind, placebo-controlled, in men
Compared against
A dummy treatment
Kind of result
A number that stands in for health
What was found
Lumbar spine 12.1% against 1.2%; total hip 2.5% against -0.5%, both P<0.001
Repeated elsewhere
Unreplicated
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
The limits of this study, and where it came from
Main limit. A surrogate endpoint, not fracture. Positively adjudicated serious cardiovascular events were 8 of 163 (4.9%) against 2 of 82 (2.5%) — the same direction as ARCH, in a trial far too small to measure it.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Subcutaneous injection, 210 mg monthly as two 105 mg prefilled syringes, for 12 doses
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
RNAWiki holds 3 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 it changes in the body◇Read from sources, not yet reviewed
The path through the body
From what a person takes to what changes. A solid line is a step measured in people. A dashed line is a step nobody has measured that way.
Start
Romosozumab
What a person takes: Subcutaneous injection, 210 mg monthly as two 105 mg prefilled syringes, for 12 doses.
The measurement behind this step
Given monthly for one year and then stopped, with an antiresorptive considered afterwards if treatment remains warranted. The fixed course is a pharmacodynamic limit, not a convenience: the bone-formation effect has reversed by month twelve.
Getting in
Two injections under the skin, once a month
The monthly dose is large enough that it comes as two separate prefilled syringes. It is given for twelve months and then stopped.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
The 210 mg monthly dose is delivered as two 105 mg single-use prefilled syringes, each 1.17 mL of a preservative-free acetate-buffered solution at pH 5.2. Median time to maximum concentration is 5 days and steady state is reached by month 3, with trough concentrations of 8 to 13 micrograms per millilitre.
The antibody finds sclerostin in the bone microenvironment
It does not act on a cell. It binds a small signalling protein released by cells buried inside bone and takes it out of circulation.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Sclerostin is a cysteine-knot protein secreted by osteocytes, encoded by SOST. Romosozumab is a humanized IgG2 that binds it directly. Estimated steady-state volume of distribution is about 3.92 L and the pharmacokinetics are non-linear, with AUC rising roughly 550-fold across a 100-fold dose range, consistent with a saturable target-mediated clearance route.
Free sclerostin normally plugs a receptor that bone-building cells need in order to hear a growth signal. Once it is mopped up, the signal gets through.
──Measured in people. Written by a person from the study named beside the step. Not signed off as a reviewed claim.
The measurement behind this step
Sclerostin binds the LRP5 and LRP6 co-receptors and blocks Wnt ligands from assembling a signalling complex with Frizzled. Removing it allows beta-catenin to accumulate and enter the nucleus, driving osteoblast differentiation and survival genes. The human genetics are the proof of the pathway: loss-of-function SOST mutations produce lifelong formation of massive amounts of normal bone.
Formation rises and resorption falls at the same time
This is the unusual part. Every other bone drug either builds or preserves. For a few months this one does both.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
P1NP rises about 145% above placebo by week 2 while CTX falls about 55% below it, an uncoupling no antiresorptive or parathyroid hormone analogue produces. The dual effect follows from Wnt signalling driving osteoblast activity and simultaneously raising osteoprotegerin, which sequesters RANKL and starves osteoclast formation.
By nine months the building signal is back to where it would have been anyway, and by twelve it is below. The label stops the treatment there.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
P1NP returns to placebo levels by month 9 and sits about 15% below placebo at month 12, while CTX remains about 25% below. After discontinuation CTX rises above baseline within 3 months. The label limits use to 12 monthly doses and directs that an antiresorptive be considered afterwards, because bone gained during the window is otherwise remodelled away.
Fewer fractures, and a cardiovascular signal that came with them
Spinal fractures fell by nearly three-quarters against placebo and hip fractures by more than a third against alendronate. In the alendronate comparison, serious heart and stroke events in the first year were more common on the antibody.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
FRAME: vertebral fracture 0.5% against 1.8% at 12 months. ARCH: hip fracture 2.0% against 3.2% at 24 months, P=0.02. Also ARCH: adjudicated serious cardiovascular adverse events in year 1, 2.5% against 1.9%. No mechanism links sclerostin inhibition to cardiovascular events with any confidence; sclerostin is expressed in vascular tissue, which is a hypothesis rather than a finding.
No suggested links are held for this record, so nothing is hidden from this path.
What we know
The record describes 6 steps from taking it to an effect in a person.
How we know it
Each step names the study behind it in the technical detail beside it.
What this does not prove
A change inside the body is a reason to look. It is not a result in a person.
Why it matters
A reader can see exactly where the chain stops being measured in people.
What we still do not know
No reviewed claim binds any of these steps to a named population.
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.
Postmenopausal women at high fracture risk, particularly those who have fractured already or failed another treatment, and who have not had a heart attack or stroke in the previous year.
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: “Safety and effectiveness of EVENITY have not been established in pediatric patients.”
US prescribing information · 471baba2-7154-4488-9891-0db2f46791e7 · read 2026-08-30
On older people, the label states: “Of the 6544 postmenopausal women with osteoporosis in the clinical studies of EVENITY, 5234 (80%) were age 65 years and over and 2390 (37%) were age 75 years and over.”
US prescribing information · 471baba2-7154-4488-9891-0db2f46791e7 · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary EVENITY is not indicated for use in women of reproductive potential.”
US prescribing information · 471baba2-7154-4488-9891-0db2f46791e7 · read 2026-08-30
On people with reduced kidney function, the label states: “No dose adjustment is required in patients with renal impairment.”
US prescribing information · 471baba2-7154-4488-9891-0db2f46791e7 · read 2026-08-30
Where the result stopped carrying
FRAME missed its non-vertebral fracture endpoint at 12 months, 1.6% against 2.1%, P=0.10
ARCH found more adjudicated serious cardiovascular events on romosozumab in the blinded first year
The United States application was not approved on the first review cycle; approval followed in April 2019 with a boxed warning for myocardial infarction, stroke and cardiovascular death
The men’s trial was powered for a density endpoint in 245 participants and reproduced the cardiovascular imbalance without being able to measure it
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 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 (11)
It was studied for a different goal
The studies measured something else entirely. Nothing in this record points to this reason.
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 injection, 210 mg monthly as two 105 mg prefilled syringes, for 12 doses
✎ 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: S6.
No source is stored against this line.
What is in the pack
Given monthly for one year and then stopped, with an antiresorptive considered afterwards if treatment remains warranted. The fixed course is a pharmacodynamic limit, not a convenience: the bone-formation effect has reversed by month twelve.
✎ 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◇Read from sources, not yet reviewed
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.
·Worth asking a clinician aboutWritten into the record from the studies named on this page
Boxed warning for potential risk of myocardial infarction, stroke and cardiovascular death. Not to be initiated in patients who have had a myocardial infarction or stroke within the preceding year, and to be discontinued if either occurs on treatment. Other labelled warnings cover hypersensitivity including angioedema and erythema multiforme, hypocalcaemia which must be corrected before starting and is a greater risk in severe renal impairment or dialysis, osteonecrosis of the jaw, and atypical femoral fracture with instruction to evaluate new thigh, hip or groin pain.
Nobody counted how many people took this and were fine, so this cannot be turned into a rate.
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 injection, 210 mg monthly as two 105 mg prefilled syringes, for 12 doses
✎ 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
The fixed course is a pharmacodynamic limit, not a convenience: the bone-formation effect has reversed by month twelve.
✎ 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 which forms are sold and how they compare.
No source is stored against this line.
What is recorded as being sold
4 products list this as an active ingredient in the United States drug directory. 4 of them contain it and nothing else.
FDA National Drug Code directory · 68225-102 · read 2026-08-29
They are sold as injection, solution, taken subcutaneous.
FDA National Drug Code directory · 68225-102 · read 2026-08-29
1 published label names it as an active ingredient. 1 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · 471baba2-7154-4488-9891-0db2f46791e7 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 471baba2-7154-4488-9891-0db2f46791e7 · read 2026-08-29
Evenity is subcutaneous at 3 DOSAGE FORMS AND STRENGTHS Injection: 105 mg/1.17 mL clear to opalescent, colorless to light yellow solution in a single-use prefilled syringe., recorded as fda label in effect 2026-07-16 in the United States.
US prescribing information · 471baba2-7154-4488-9891-0db2f46791e7 · 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 Romosozumab 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
Claims that go past the evidence
Things said about this substance that sound reasonable, and the exact step that is missing between the evidence and the claim.
✗Goes past the evidence
That the fracture benefit continues beyond twelve months — the pharmacodynamic effect has reversed by then and the label caps the course there
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That the cardiovascular imbalance is explained; no mechanism has been established and vascular sclerostin expression is a hypothesis
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That a 12.1% spinal density gain in 245 men implies the fracture reduction measured in women
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That an antibody given for twelve months reproduces the skeletal phenotype of lifelong SOST deficiency, which includes cranial nerve compression
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
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 Romosozumab 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.
Every line above can be traced to the study named beside it. Follow the link and read it.
Spinal fractures fell by nearly three-quarters within twelve months
In plain words
In 7180 women, new spinal fractures on x-ray occurred in about five per thousand on the drug against eighteen per thousand on placebo over one year, and the gap persisted after both groups moved to a different drug.
What was measured
New vertebral fracture at 12 months, 0.5% against 1.8%, a 73% lower risk (P<0.001)
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
FRAME enrolled 7180 postmenopausal women with a T-score of -2.5 to -3.5 at the total hip or femoral neck, randomised to monthly subcutaneous romosozumab 210 mg or placebo for 12 months, after which all received denosumab for 12 months. New vertebral fractures at 12 months occurred in 16 of 3321 (0.5%) against 59 of 3322 (1.8%), a 73% lower risk, P<0.001. At 24 months, after both groups had transitioned to denosumab, the rates were 0.6% against 2.5%, a 75% lower risk, P<0.001. Clinical fractures at 12 months were 58 of 3589 (1.6%) against 90 of 3591 (2.5%), 36% lower, P=0.008.
Written into the record, not signed off as a reviewed claim
Non-vertebral fractures were not significantly reduced in the pivotal trial
In plain words
The fractures that happen outside the spine — wrists, hips, arms — were slightly fewer on the drug, but the difference did not reach statistical significance.
What was measured
Non-vertebral fracture 1.6% against 2.1% at 12 months, P=0.10
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
In FRAME, non-vertebral fractures at 12 months occurred in 56 of 3589 romosozumab patients (1.6%) against 75 of 3591 placebo patients (2.1%), P=0.10. The trial met both co-primary vertebral endpoints and the clinical fracture secondary endpoint, and missed this one. It is the reason the second trial mattered: ARCH, in a higher-risk population and against an active comparator rather than placebo, did show significant reductions in non-vertebral fracture, 8.7% against 10.6%, P=0.04, and in hip fracture, 2.0% against 3.2%, P=0.02.
Written into the record, not signed off as a reviewed claim
The head-to-head trial found more serious cardiovascular events in year one
In plain words
When the drug was compared with alendronate, it prevented more fractures. In the first year, serious heart and stroke events adjudicated by an independent committee occurred in 50 patients on the drug against 38 on alendronate.
What was measured
Positively adjudicated serious cardiovascular adverse events in year 1: 50 of 2040 (2.5%) against 38 of 2014 (1.9%)
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
ARCH enrolled 4093 postmenopausal women with osteoporosis and a fragility fracture, randomised 1:1 to monthly romosozumab 210 mg or weekly oral alendronate 70 mg blinded for 12 months, followed by open-label alendronate in both arms. During year 1, positively adjudicated serious cardiovascular adverse events occurred in 50 of 2040 romosozumab patients (2.5%) against 38 of 2014 alendronate patients (1.9%). Overall adverse events and serious adverse events were balanced. During the open-label alendronate period, adjudicated osteonecrosis of the jaw occurred once in each group and atypical femoral fracture twice on the romosozumab-to-alendronate arm against four times on alendronate throughout. The imbalance in year 1 is the basis of the boxed warning: the label states that romosozumab may increase the risk of myocardial infarction, stroke and cardiovascular death, must not be started within a year of either event, and should be discontinued if either occurs on treatment.
Written into the record, not signed off as a reviewed claim
It beat alendronate on every fracture endpoint including hip
In plain words
Over two years, women who got twelve months of the antibody followed by alendronate had roughly half as many spinal fractures and a third fewer hip fractures than women who took alendronate the whole time.
What was measured
Hip fracture over 24 months, 2.0% against 3.2% on alendronate throughout, a 38% lower risk (P=0.02)
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
In ARCH over 24 months, new vertebral fracture occurred in 127 of 2046 (6.2%) in the romosozumab-to-alendronate group against 243 of 2047 (11.9%) in the alendronate-to-alendronate group, a 48% lower risk, P<0.001. Clinical fractures were 198 of 2046 (9.7%) against 266 of 2047 (13.0%), 27% lower, P<0.001. Non-vertebral fractures were 178 (8.7%) against 217 (10.6%), 19% lower, P=0.04. Hip fractures were 41 (2.0%) against 66 (3.2%), 38% lower, P=0.02. Because the comparator was an active drug with its own established fracture reduction rather than placebo, these are differences on top of effective treatment.
Written into the record, not signed off as a reviewed claim
The whole drug was reasoned backwards from a rare bone disease
In plain words
People born with two broken copies of one gene grow abnormally thick, dense bone for their whole lives. Finding that gene in 2001 identified the brake on bone formation, and this drug removes that brake deliberately.
What was measured
Three loss-of-function SOST mutations identified in sclerosteosis patients, producing lifelong excess formation of normal bone
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Balemans and colleagues mapped sclerosteosis and van Buchem disease to the same region of chromosome 17q12-q21, narrowed the critical interval to about 1 Mb, and positionally cloned SOST. Two nonsense mutations and one splice-site mutation were found in sclerosteosis patients. The paper states that loss of SOST function results in formation of massive amounts of normal bone throughout life, that the physiological role of the protein is most likely suppression of bone formation, and — in its final sentence — that the gene might become an important tool for developing osteoporosis therapies. That was eighteen years before approval. The disease also shows the ceiling: sclerosteosis causes cranial nerve compression with facial palsy, hearing loss and optic atrophy from skull overgrowth, which is what a lifetime of complete sclerostin absence looks like as against twelve monthly doses of an antibody.
Written into the record, not signed off as a reviewed claim
Approved for men on a bone-density endpoint in 245 people
In plain words
The trial in men measured the number on a scan, not fractures, in 245 participants. It also showed the same numerical excess of serious heart events.
What was measured
That a 12.1% rise in spinal bone density in 245 men implies the fracture reduction measured in 7180 women — a surrogate result in a small trial, with the same cardiovascular imbalance present
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
BRIDGE randomised 245 men aged 55 to 90 with a T-score of -2.5 or lower, or -1.5 or lower with a prior fragility fracture, 2:1 to romosozumab 210 mg monthly or placebo for 12 months at 31 centres. The primary endpoint was percentage change from baseline in lumbar spine bone mineral density at month 12: 12.1% against 1.2%, and total hip 2.5% against -0.5%, both P<0.001. Adverse and serious adverse events were balanced, with a numerical imbalance in positively adjudicated serious cardiovascular events — 8 of 163 (4.9%) against 2 of 82 (2.5%). No fracture endpoint was measured. The current United States indication is confined to postmenopausal women, so this trial supports a mechanism in men rather than an approved use.
Written into the record, not signed off as a reviewed claim
The effect is transient by design, and the label caps the course at twelve doses
In plain words
The bone-building signal peaks two weeks in and is gone by nine months. By month twelve it has fallen below where it started. The course is limited to twelve doses because after that there is nothing left to gain.
What was measured
P1NP +145% at week 2, back to placebo by month 9, about 15% below placebo at month 12; CTX -55% at week 2, about 25% below at month 12
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The label reports that P1NP, the formation marker, peaks at about 145% above placebo two weeks after starting, returns to placebo levels by month 9, and is approximately 15% below the placebo change by month 12. CTX, the resorption marker, falls to about 55% below placebo at two weeks and remains about 25% below at month 12. After discontinuation, P1NP returns to baseline within 12 months while CTX rises above baseline within 3 months and returns toward baseline by month 12. The label limits use to 12 monthly doses and states that if osteoporosis therapy remains warranted, continued therapy with an antiresorptive should be considered. This is one of the few drugs whose approved duration is set by its own pharmacodynamic curve rather than by a trial comparison.
Source
EVENITY United States prescribing information, Indications and Usage 1.2 and Clinical Pharmacology 12.2 (openFDA label endpoint)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
Where else this substance is registered
FDA substance identifier (UNII)
3VHF2ZD92J
CAS registry number
909395-70-6
ChEMBL
CHEMBL2107874
WHO international nonproprietary name list entry
9533
RxNorm concept
2123126
EMA substance identifier
100000173984
DrugBank
DB11866
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: 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
The earliest marketing start date recorded for a listed product is 20190409.
FDA National Drug Code directory · 68225-102 · read 2026-08-29
What is missing or unclear◇Read from sources, not yet reviewed
What to learn next
Ordered by what would most change how you read this page, starting with what is easiest to misunderstand.
This order is fixed in code and does not count clicks or time on the page.
What is not here
7 questions this page could not answer
These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.
What was measured, goal by goal — found nothing in the sources checked.
How close this is to real life — found nothing in the sources checked.
Felt, measured, or meaningful — found nothing in the sources checked.
How long anything takes — found nothing in the sources checked.
What it may clash with — found nothing in the sources checked.
Other ways to the same goal — found nothing in the sources checked.
What changed on this page — found nothing in the sources checked.
The record as stored
The full record, for auditing
Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.
The older medicine-wide conclusion held in this record
Written for a clinical reader, and about the medicine as a whole rather than about one indication, population and set of trials. RNAWiki does not treat it as a programme conclusion and no reviewer has signed it off in that form. It is here word for word because it is what the record holds.
An antibody against sclerostin, the bone-formation brake whose genetic absence causes a rare high-bone-mass disease, which cut new spinal fractures from 1.8% to 0.5% in twelve months in 7180 women and beat alendronate on hip fracture, 2.0% against 3.2%, in 4093 women — and in that same head-to-head trial produced more adjudicated serious cardiovascular events in year one, 2.5% against 1.9%, which is now its boxed warning.
Recorded evidence blocks (8)
Q2
On the Romosozumab label: indicated for what?
"EVENITY is a sclerostin inhibitor indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. ( 1 ) Limitations…": indications and usage on Romosozumab's label. DailyMed label · 471baba2-7154-4488-9891-0db2f46791e7 · 2026-07-16
Q3
41 registered trials of Romosozumab — at which phases?
"Investigator left the institution"; 1 of 41 registered studies
Show the evidence
TrialNCT06973109
withdrawn; "Investigator left the institution"
recorded 2026-09-01 · last checked 2026-09-04
Q5
Human studies of Romosozumab used Romosozumab 90 mg/mL — over how long?
studies of Romosozumab used the recorded amount. ClinicalTrials.gov · 2026-09-01
2 recorded entries; human; also "Romosozumab 90 mg/mL", "Romosozumab 70 mg/mL"
Show the evidence
human
NCT02016716
Romosozumab 90 mg/mL
NCT02016716
Romosozumab 70 mg/mL
recorded 2026-09-01 · last checked 2026-09-04
Q6
Which one trial of Romosozumab posted no result?
Posted no result
1 of 1 completed trials
Registrations
NCT04091243
Completion dates
oldest 2023-11-15
Show the evidence
TrialNCT04091243
2023-11-15
Q7
At the median, Romosozumab's trials enrolled 74 people — anything larger?
Median enrolment
74
Largest enrolment
7180
Registered trials counted
41
Q8
What do 887 spontaneous reports say about Romosozumab — 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.
Romosozumab appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 887 reaction mentions were counted: fall 228; injection site pain 132; fracture 91; injection site swelling 78. FAERS via Open Targets · CHEMBL2107874 · 2026-06-24
Show the evidence
fall
228
injection site pain
132
fracture
91
injection site swelling
78
hospitalisation
70
injection site erythema
67
4 more recorded rows
renal impairment
57
spinal compression fracture
56
femur fracture
55
cardiac failure
53
recorded 2026-06-24 · last checked 2026-09-04
Q9
Which 10 reactions does Romosozumab's label not list?
ChEMBL 37 — CC BY-SA 3.0 Unported · ChEMBL ATC CC BY-SA · ClinicalTrials.gov — US Government work · Open Targets 26.06 — CC0 · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work
✗ required summary fields resolved: 4 required field(s) not terminal: Why people use it, Best-supported result, Biggest unanswered question, Human evidence
✓ public claims reviewed: 0 reviewed claim(s); drafts are never rendered
✓ source coverage passed: 6 source rows
✓ no critical contamination: no quarantine open
✓ canonical metadata passed: slug and display name present
✓ no raw internal fields: enforced by the copy-contract test over the rendered page
This is a record of evidence. It is not medical advice, and it does not say this substance suits you. Nothing here says any substance on RNAWiki is appropriate for a child.