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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03623633
The ClinicalTrials.gov registry entry for NCT03623633 describes a study currently listed as active not recruiting, categorized as Phase 4. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,545-participant average among 84 other Osteoporosis trials with a reported enrollment target (97% lower). The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Related
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