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Effects of Romosozumab on Bone Density in Women With Anorexia Nervosa

NCT04779216 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-12-16

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 romosozumab on BMD in women with anorexia nervosa. The investigators will also investigate the safety of romosozumab in women with anorexia nervosa. The investigators hypothesize that 12 months of romosozumab administration will result in an increase in bone mineral density, increase in markers of bone formation and decrease in markers of bone resorption, and improvement in bone microarchitecture in osteopenic women with anorexia nervosa compared with placebo.

In Phase 2, participants will receive a single infusion of open-label zoledronic acid (an intravenous bisphosphonate) 5 mg after the initial 12-month administration of romosozumab or placebo. The investigators hypothesize that 12 months of romosozumab followed by a single intravenous infusion of open-label zoledronic acid will result in a greater increase in BMD compared to 12 months of placebo followed by a single intravenous infusion of open-label zoledronic acid. Within the group of women who receive sequential therapy with 12 months of romosozumab followed by a single intravenous infusion of zoledronic acid, the investigators hypothesize BMD will be maintained between 12 and 24 months following administration of zoledronic acid.

Conditions

Interventions

DRUG

Romosozumab Prefilled Syringe

Romosozumab 210mg Injection monthly for 12 months

DRUG

Placebo

Placebo Injection monthly for 12 months

DRUG

Zoledronic acid 5 mg

A single infusion of open-label zoledronic acid 5 mg after the initial 12-month administration of romosozumab or placebo

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • Karen Klahr Miller, MD

    lead OTHER

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
2021-09-20
Primary Completion
2024-10-24
Completion
2025-11-17
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

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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 NCT04779216 on ClinicalTrials.gov