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NCT04800367 · ClinicalTrials.gov registry record · Phase 2
Romosozumab/Denosumab Study for Premenopausal IOP
A Phase 2 study of Premenopausal Idiopathic Osteoporosis, sponsored by Columbia University.
- Active
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT04800367: Active Phase 2 study of Premenopausal Idiopathic Osteoporosis, sponsored by Columbia University.
NCT04800367 is a Phase 2 study of Premenopausal Idiopathic Osteoporosis that is active but no longer recruiting, run by Columbia University. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04800367, a Phase 2 study of Premenopausal Idiopathic Osteoporosis, is active but no longer recruiting, sponsored by Columbia University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Within-group percent change in lumbar spine BMD by DXA at 12M
Conditions Studied
Interventions
- DRUG Romosozumab Prefilled Syringe [Evenity]
- DRUG Denosumab 60 MG/ML Prefilled Syringe [Prolia]
Study Locations (1)
New York
- Columbia University Irving Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2021-03-12 |
| Est. Completion | 2028-03 |
| Phase | Phase 2 |
What the registry record for NCT04800367 still lists
NCT04800367 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 1 condition, with Premenopausal Idiopathic Osteoporosis appearing as the primary indexed condition, and to 2 interventions - of which Romosozumab Prefilled Syringe [Evenity] is the first listed.
NCT04800367 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT04800367 about?
NCT04800367 is a clinical study titled "Romosozumab/Denosumab Study for Premenopausal IOP". 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 p...
What is the current status of trial NCT04800367?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2021-03-12. Estimated completion is 2028-03.
What conditions does trial NCT04800367 study?
This clinical trial studies the following conditions: Premenopausal Idiopathic Osteoporosis.
What interventions are being tested in trial NCT04800367?
The interventions under investigation include: Romosozumab Prefilled Syringe [Evenity] (DRUG), Denosumab 60 MG/ML Prefilled Syringe [Prolia] (DRUG).
Who is sponsoring clinical trial NCT04800367?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04800367 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04800367's enrollment target sits among peer trials
30 1582nd of 2000 higher than 332 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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