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NCT03292146 · ClinicalTrials.gov registry record · Phase 3
Effects of Denosumab on Bone Mineral Density in Women With Anorexia Nervosa: A Pilot Study
A Phase 3 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 3
- Development phase
- 30
- Enrollment target
NCT03292146: Completed Phase 3 study, sponsored by Massachusetts General Hospital.
NCT03292146 is a Phase 3 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 30 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03292146, a Phase 3 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 30 participants
- Enrollment target
Study Summary
This protocol is a randomized, double-blind, placebo-controlled clinical trial which aims to investigate the effect of denosumab on BMD in women with anorexia nervosa. The investigators hypothesize that 12 months of denosumab administration will result in an increase in bone mineral density, decrease in markers of bone resorption and improvement in bone microarchitecture in osteopenic women with anorexia nervosa compared with placebo. An optional extension study will offer subjects 12-month administration of open-label alendronate (an oral bisphosphonate) after the initial 12 month administration of denosumab or placebo. We hypothesize that 12 months of denosumab followed by 12 months of open-label alendronate will result in a greater increase in BMD compared to 12 months of placebo followed by 12 months of open-label alendronate. Within the group of women who receive sequential therapy with 12 months of denosumab followed by 12 months of alendronate, we hypothesize that BMD will be maintained between 12 and 24 months while on alendronate.
Primary Outcome
Postero-anterior (PA) lumbar spine bone mineral density was assessed by dual-energy x-ray absorptiometry (DXA). The DXA scanner used was a Hologic Horizon A (Hologic, Inc., Waltham, MA).
Interventions
- DRUG Placebo Injection
- DRUG Denosumab 60 MG [Prolia]
- DRUG Alendronate 70Mg Tab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2017-10-25 |
| Est. Completion | 2021-07-22 |
| Phase | Phase 3 |
What the finished NCT03292146 record still lists
NCT03292146 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 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo Injection is the first listed.
NCT03292146 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03292146 about?
NCT03292146 is a clinical study titled "Effects of Denosumab on Bone Mineral Density in Women With Anorexia Nervosa: A Pilot Study". This protocol is a randomized, double-blind, placebo-controlled clinical trial which aims to investigate the effect of denosumab on BMD in women with anorexia nervosa. The investigators hypothesize that 12 months of denosumab administration will result in an increase in bone mineral density, decreas...
What is the current status of trial NCT03292146?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 30 participants. The study started on 2017-10-25. Estimated completion is 2021-07-22.
What interventions are being tested in trial NCT03292146?
The interventions under investigation include: Placebo Injection (DRUG), Denosumab 60 MG [Prolia] (DRUG), Alendronate 70Mg Tab (DRUG).
Who is sponsoring clinical trial NCT03292146?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03292146's enrollment target sits among peer trials
30 1917th of 2000 higher than 68 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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