Effects of Romosozumab on Bone Density, Markers of Bone Metabolism and Bone Microarchitecture in Women With Anorexia Nervosa: A Pilot Study

Who is this study for? Women With anorexia nervosa
What treatments are being studied? Romosozumab
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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. The extension study will offer subjects 12-month administration of open-label alendronate (an oral bisphosphonate) 70 mg once weekly after the initial 12 month administration of romosozumab or placebo. The investigators hypothesize that 12 months of romosozumab 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 romosozumab followed by 12 months of alendronate, the investigators hypothesize that BMD will be maintained between 12 and 24 months while on alendronate.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 20
Maximum Age: 60
Healthy Volunteers: No
View:

• 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), intrauterine hormonal-releasing system (IUS), surgery to tie both fallopian tubes (bilateral tubal ligation/occlusion), and 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

Locations
United States
Massachusetts
Massachusetts General Hospital
Recruiting
Boston
Contact Information
Primary
Karen K Miller, MD
kkmiller@mgh.harvard.edu
617-726-3870
Backup
Erinne Meenaghan, NP
emeenaghan@mgh.harvard.edu
617-724-7393
Time Frame
Start Date: September 20, 2021
Estimated Completion Date: January 2025
Participants
Target number of participants: 30
Treatments
Experimental: Active Romosozumab 210mg Injection
Romosozumab 210mg injection monthly for 12 months. Alendronate 70mg PO weekly starting at Month 12 through 24 months.
Placebo Comparator: Placebo
Placebo injection monthly for 12 months. Alendronate 70mg PO weekly starting at Month 12 through 24 months.
Related Therapeutic Areas
Sponsors
Collaborators: Amgen
Leads: Karen Klahr Miller, MD

This content was sourced from clinicaltrials.gov

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