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

NCT03292146 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: 2017P000529
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Postero-anterior (PA) Lumbar Spine Bone Mineral Density by Dual-energy X-ray Absorptiometry (DXA)

  Postero-anterior (PA) lumbar spine bone mineral density was assessed by dual-energy x-ray absorptiometry (DXA). The DXA scanner used was a Hologic Horizon A (Hologic, Inc., Waltham, MA).

  12 months (Period 1)

Secondary Outcomes (2)

• Percent Change Postero-anterior (PA) Lumbar Spine Bone Mineral Density by DXA

  Baseline to 24 months

• Percent Change Postero-anterior (PA) Lumbar Spine Bone Mineral Density by DXA

  12 months to 24 months (Period 2)

Study Arms (2)

Active Denosumab 60mg Injection

EXPERIMENTAL

Denosumab 60mg injection at baseline study visit and 6 month study visit. Alendronate 70mg PO weekly starting at Month 12 through 24 months.

Drug: Denosumab 60 MG [Prolia]; Drug: Alendronate 70Mg Tab

Placebo

PLACEBO COMPARATOR

Placebo injection at baseline study visit and 6 month study visit. Alendronate 70mg PO weekly starting at Month 12 through 24 months.

Drug: Placebo Injection; Drug: Alendronate 70Mg Tab

Interventions

Denosumab 60 MG [Prolia] DRUG

Denosumab 60mg injection at baseline and 6 months

Active Denosumab 60mg Injection

Placebo Injection DRUG

Placebo Injection at baseline and 6 months

Placebo

Alendronate 70Mg Tab DRUG

Alendronate 70mg PO weekly starting at Month 12 through 24 months.

Active Denosumab 60mg Injection; Placebo

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• Female
• Age 20-60 years, skeletally mature with closed epiphyses
• Anorexia nervosa or atypical anorexia nervosa defined by DSM-V diagnostic criteria
• BMD T-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)
• Intraduterine hormonal-releasing system (IUS)
• Surgery to tie both fallopian tubes (bilateral tubal ligation/occlusion)
• Your male partner has had a vasectomy and testing shows there is no sperm in the semen
• Dental check up within the past year
• Any disease known to affect bone, including untreated thyroid dysfunction, Cushing's or renal failure
• Subjects with a known esophageal disease cannot participate in the alendronate extension study
• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Amgen: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic; Anorexia Nervosa; Feeding and Eating Disorders

Interventions

Denosumab; Alendronate

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Mental Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals

Results Point of Contact

• Title: Karen K. Miller, MD
• Organization: Massachusetts General Hospital

KKMILLER@mgh.harvard.edu

617-724-7388

Study Officials

• Karen K Miller, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: September 21, 2017
• First Posted: September 25, 2017
• Study Start: October 25, 2017
• Primary Completion: July 22, 2021
• Study Completion: July 22, 2021
• Last Updated: November 4, 2025
• Results First Posted: October 12, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)