MedDataX Logo

Effects of Romosozumab on Bone Density in Women With Anorexia Nervosa

NCT ID: NCT04779216

Last Updated: 2025-12-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-20

Study Completion Date

2025-11-17

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bone Density, Low Bone Loss Anorexia Nervosa Eating Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
Double Blind

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Active Romosozumab 210mg Injection

Romosozumab 210mg injection monthly for 12 months. A single infusion of open-label zoledronic acid 5 mg after the initial 12-month administration of romosozumab.

Group Type EXPERIMENTAL

Romosozumab Prefilled Syringe

Intervention Type DRUG

Romosozumab 210mg Injection monthly for 12 months

Zoledronic acid 5 mg

Intervention Type DRUG

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

Placebo

Placebo injection monthly for 12 months. A single infusion of open-label zoledronic acid 5 mg after the initial 12-month administration of placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo Injection monthly for 12 months

Zoledronic acid 5 mg

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Romosozumab Prefilled Syringe

Romosozumab 210mg Injection monthly for 12 months

Intervention Type DRUG

Placebo

Placebo Injection monthly for 12 months

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Zoledronate, Reclast

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Female
* Age 20-60 years, skeletally mature with closed epiphyses
* Body mass index (BMI) ≥ 16.5 kg/m2
* Anorexia nervosa or atypical anorexia nervosa defined by DSM-V diagnostic criteria
* BMD Z-score \< -1.0
* Normal serum 25-OH vitamin D (\>30 ng/mL) and calcium levels
* For women of reproductive age, agree to use an effective contraceptive method. Highly effective methods of birth control include: Combined (estrogen and progestogen) hormonal methods (pills, vaginal ring, or skin patch); Intrauterine device (IUD); Intrauterine hormonal-releasing system (IUS); Surgery to tie both fallopian tubes (bilateral tubal ligation/occlusion); Woman's male partner has had a vasectomy and testing shows there is no sperm in the semen
* Dental check-up within the past year

Exclusion Criteria

* Hospitalization within 3 months of baseline study visit, including inpatient eating disorder treatment facility; participating in a residential eating disorder treatment program within 3 months of study participation is permitted
* Myocardial infarction or stroke within 1 year preceding enrollment
* History of hypertension or use of anti-hypertensive medications within the past 6 months
* Any disease known to affect bone, including untreated thyroid dysfunction, Cushing's or renal failure
* Any medication known to affect bone metabolism within 3 months of the study, excluding oral contraceptives or other forms of estrogen administration. Bisphosphonates must have been discontinued for at least one year before participation
* Immunodeficiency or taking immunosuppressive therapy
* Serum 25-OH vitamin D level \<30 ng/mL
* Serum potassium \<3.0 meq/L
* Serum magnesium \<1.5 meq/L
* Serum ALT \>3 times upper limit of normal
* eGFR of less than 30 ml/min
* LDL \> 190 mg/dL
* Hypocalcemia
* Diabetes mellitus
* Active substance abuse, including alcohol
* Current smoker
* History of malignancy
* Paget disease of bone
* Osteomalacia
* Osteonecrosis of the jaw (ONJ) or risk factor for ONJ, such as invasive dental procedures (eg, tooth extraction, dental implants, oral surgery in the past 6 months), poor oral hygiene, periodontal and/or pre-existing dental disease, and current use of corticosteroids.
* Planned invasive dental procedure over the next 24 months
* Known sensitivity to any of the products or components of the medication to be administered
* Sensitivity to calcium or vitamin D supplements
* Pregnant, planning to become pregnant within 12 months after the end of treatment and/or breastfeeding
* Hypersensitivity to any component of zoledronic acid
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Amgen

INDUSTRY

Sponsor Role collaborator

Karen Klahr Miller, MD

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Karen Klahr Miller, MD

Professor of Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2020P000329

Identifier Type: -

Identifier Source: org_study_id