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

NCT03292146 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-11-04

Study results available
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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

  • Bone Density
  • Bone Loss
  • Anorexia Nervosa
  • Eating Disorder
  • Atypical Anorexia Nervosa

Interventions

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.

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Karen K Miller, MD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-25
Primary Completion
2021-07-22
Completion
2021-07-22
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03292146 on ClinicalTrials.gov