Trials / Completed
CompletedNCT03292146
Effects of Denosumab on Bone Mineral Density in Women With Anorexia Nervosa: A Pilot Study
Effects of Denosumab on Bone Mineral Density, Markers of Bone Metabolism and Bone Microarchitecture in Women With Anorexia Nervosa: A Pilot Study
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Massachusetts General Hospital · Academic / Other
- Sex
- Female
- Age
- 20 Years – 60 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Denosumab 60 MG [Prolia] | Denosumab 60mg injection at baseline and 6 months |
| DRUG | Placebo Injection | Placebo Injection at baseline and 6 months |
| DRUG | Alendronate 70Mg Tab | Alendronate 70mg PO weekly starting at Month 12 through 24 months. |
Timeline
- Start date
- 2017-10-25
- Primary completion
- 2021-07-22
- Completion
- 2021-07-22
- First posted
- 2017-09-25
- Last updated
- 2025-11-04
- Results posted
- 2022-10-12
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03292146. Inclusion in this directory is not an endorsement.