Effects of Denosumab on Bone Mineral Density in Women With Anorexia Nervosa: A Pilot Study

Anorexia Nervosa Clinical Trial

Official title: Effects of Denosumab on Bone Mineral Density, Markers of Bone Metabolism and Bone Microarchitecture in Women With Anorexia Nervosa: A Pilot Study

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa
• Atypical Anorexia Nervosa
• Bone Density
• Bone Loss
• Eating Disorder
• Feeding and Eating Disorders

• NCT number: NCT03292146
• Study type: Interventional
• Source: Massachusetts General Hospital
• Status: Completed
• Phase: Phase 3
• Start date: October 25, 2017
• Completion date: July 22, 2021