Status:
COMPLETED
Effects of Denosumab on Bone Mineral Density in Women With Anorexia Nervosa: A Pilot Study
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Amgen
Conditions:
Bone Density
Bone Loss
Eligibility:
FEMALE
20-60 years
Phase:
PHASE3
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 th...
Eligibility Criteria
Inclusion
- Inclusion/
Exclusion
- Inclusion Criteria:
- 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
Key Trial Info
Start Date :
October 25 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 22 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03292146
Start Date
October 25 2017
End Date
July 22 2021
Last Update
November 4 2025
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114