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Romozosumab

Phase 3

Postmenopausal Osteoporosis | Small molecule | Endocrine |Amgen Inc.|Last Updated: Nov 29, 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment436

FDA Designations

No designations recorded

Clinical trial landscape

Romozosumab · 1 trial · 1 indication

Phase 3 1
NCT01796301An Open-label Study to Evaluate the Effect of Treatment With Romosozumab or Teriparatide in Postmenopausal WomenPostmenopausal Osteoporosis
COMPLETED436 Analytics
PHASE3COMPLETED
An Open-label Study to Evaluate the Effect of Treatment With Romosozumab or Teriparatide in Postmenopausal Women
Postmenopausal Osteoporosis
NCT01796301436
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Study Endpoints

Primary Endpoints

Percent Change From Baseline Through Month 12 in Total Hip Bone Mineral Density (BMD)
Baseline, month 6 and month 12

Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA). Percent change from baseline through month 12 is the average of the treatment effect at months 6 and 12.

Secondary Endpoints

Percent Change From Baseline in Total Hip BMD at Month 6
Baseline and month 6
Percent Change From Baseline in Total Hip BMD at Month 12
Baseline and month 12
Percent Change From Baseline in Cortical BMD by Quantitative Computed Tomography (QCT) at the Total Hip at Month 6
Baseline and month 6
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
RomosozumabEXPERIMENTALParticipants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
TeriparatideACTIVE_COMPARATORParticipants received 20 μg/day teriparatide administered by subcutaneous injection for 12 months.

Interventions

NameTypeDescription
RomozosumabDRUGAdministered by subcutaneous injection once a month.
TeriparatideDRUGAdministered by subcutaneous injection once a day.
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Eligibility Criteria

Age Range55 Years to 90 Years
SexFEMALE
Healthy VolunteersNo
Study Sites50

Inclusion Criteria: * Postmenopausal women, aged ≥ 55 to ≤ 90. * Received oral bisphosphonate therapy for at least 3 years immediately prior to screening * BMD T-score ≤ -2.50 at the lumbar spine, total hip or femoral neck * History of nonvertebral fracture after age 50, or vertebral fracture. Exc...

Countries:United StatesArgentinaBelgiumCanadaColombiaCzechiaDenmarkHungaryPolandSpainUnited Kingdom
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Frequently asked questions about Romozosumab

What is Romosozumab used for?

Romosozumab is an investigational small molecule being developed for the treatment of postmenopausal osteoporosis. It is currently in Phase 3 clinical development and has not been approved by the FDA. The drug is intended for use in postmenopausal women with this condition.

Who makes Romosozumab?

Romosozumab is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with postmenopausal osteoporosis.

What phase is Romosozumab in?

Romosozumab is in Phase 3 clinical development. It is an investigational drug and has not yet received regulatory approval. One Phase 3 trial has been completed, and the drug remains under investigation for the treatment of postmenopausal osteoporosis.

What clinical trials is Romosozumab in?

Romosozumab has been studied in a completed Phase 3 clinical trial with the identifier NCT01796301. This open-label, active-controlled study evaluated the effect of treatment with Romosozumab compared to teriparatide in postmenopausal women with osteoporosis. The trial enrolled 436 participants across multiple countries.

How does Romosozumab work?

Romosozumab is a small molecule being developed for postmenopausal osteoporosis. The specific molecular target of the drug has not been disclosed in available information. Clinical trials are evaluating its effects compared to an active control in postmenopausal women.