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Romosozumab/Denosumab Study for Premenopausal IOP

NCT04800367 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-02-27

No results posted yet for this study

Summary

The overarching goal of the research program is to define optimal treatment for premenopausal women with clinically significant fracture syndromes that require medical therapy. The investigators hypothesize that romosozumab will be associated with improvements in bone mass and microarchitecture in premenopausal women, and also that the responses and response rates will exceed those observed in premenopausal women treated with teriparatide. The investigators will test this hypothesis in this phase 2 study of 30 premenopausal women with idiopathic osteoporosis (IOP) who will receive 12M of romosozumab 210 mg monthly followed by 12M of denosumab 60 mg SC q6M. Aim 1 will define the within-group effects of this regimen. Aim 2 will compare results from participants treated with romosozumab-denosumab to the investigator's well-characterized historical controls treated with teriparatide followed by denosumab.

Conditions

  • Premenopausal Idiopathic Osteoporosis

Interventions

DRUG

Romosozumab Prefilled Syringe [Evenity]

2 syringes of 105 MG/1.17 mL subcutaneous solution injected one after the other, once a month from study baseline through 11 month visit

DRUG

Denosumab 60 MG/ML Prefilled Syringe [Prolia]

1 subcutaneous injection of 60 mg/mL every six months from study 12 month visit through the 24 month visit. Injections occur at the 12 and 18 month visits.

Sponsors & Collaborators

Principal Investigators

  • Adi Cohen, MD · Columbia University

  • Elizabeth Shane, MD · Columbia University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-12
Primary Completion
2027-03-31
Completion
2028-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04800367 on ClinicalTrials.gov