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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. 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03292146
The ClinicalTrials.gov registry entry for NCT03292146 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo Injection is the first listed.
NCT03292146 reports 0 study locations.
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.
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