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NCT03623633 · ClinicalTrials.gov registry record · Phase 4
Comparative Antiresorptive Efficacy Discontinuation of Denosumab
A Phase 4 study of Osteoporosis and Osteoporosis, Postmenopausal, sponsored by Massachusetts General Hospital.
- Active
- Registry status
- Phase 4
- Development phase
- 51
- Enrollment target
- 1
- Study location
NCT03623633: Active Phase 4 study of Osteoporosis and Osteoporosis, Postmenopausal, sponsored by Massachusetts General Hospital.
NCT03623633 is a Phase 4 study of Osteoporosis and Osteoporosis, Postmenopausal that is active but no longer recruiting, run by Massachusetts General Hospital. The registered enrollment target is 51 participants, below the 1,545-participant average among 84 other Osteoporosis trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03623633, a Phase 4 study of Osteoporosis and Osteoporosis, Postmenopausal, is active but no longer recruiting, sponsored by Massachusetts General Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 51 participants
- Enrollment target
- 1
- Study location
Study Summary
Osteoporosis remains a significant healthcare burden for the United States. Current FDA-approved osteoporosis treatments include teriparatide, abaloparatide, bisphosphonates, denosumab, and raloxifene. Denosumab is a fully human monoclonal antibody that specifically binds to receptor activator of nuclear factor kappa-B ligand (RANKL). Denosumab potently suppresses osteoclastic activity but bone turnover rapidly normalizes and bone turnover marker levels can rebound above baseline levels after the drug is discontinued. This study will help us determine the optimal duration and relative efficacy of two oral antiresorptive medications that are FDA-approved for treatment of postmenopausal osteoporosis (alendronate and raloxifene) in preventing the rebound increase in bone turnover that occurs after denosumab discontinuation.
Primary Outcome
Change in serum CTX between month 12 and month 18
Conditions Studied
Interventions
- DRUG raloxifene
- DRUG denosumab
- DRUG alendronate
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2018-11-30 |
| Est. Completion | 2023-08-01 |
| Phase | Phase 4 |
What the registry record for NCT03623633 still lists
NCT03623633 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 1,545-participant average among 84 other Osteoporosis trials with a reported enrollment target (97% lower).
The record links to 2 conditions, with Osteoporosis appearing as the primary indexed condition, and to 3 interventions - of which raloxifene is the first listed.
NCT03623633 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03623633 about?
NCT03623633 is a clinical study titled "Comparative Antiresorptive Efficacy Discontinuation of Denosumab". Osteoporosis remains a significant healthcare burden for the United States. Current FDA-approved osteoporosis treatments include teriparatide, abaloparatide, bisphosphonates, denosumab, and raloxifene. Denosumab is a fully human monoclonal antibody that specifically binds to receptor activator of n...
What is the current status of trial NCT03623633?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 51 participants. The study started on 2018-11-30. Estimated completion is 2023-08-01.
What conditions does trial NCT03623633 study?
This clinical trial studies the following conditions: Osteoporosis, Osteoporosis, Postmenopausal.
What interventions are being tested in trial NCT03623633?
The interventions under investigation include: raloxifene (DRUG), denosumab (DRUG), alendronate (DRUG).
Who is sponsoring clinical trial NCT03623633?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03623633 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Osteoporosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03623633's enrollment target sits among peer trials
51 56th of 84 higher than 29 of 84 other Osteoporosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Osteoporosis 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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