Status:
COMPLETED
Effects of Romosozumab on Bone Density in Women With Anorexia Nervosa
Lead Sponsor:
Karen Klahr Miller, MD
Collaborating Sponsors:
Amgen
Conditions:
Bone Density, Low
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 romosozumab on BMD in women with anorexia nervosa. The investigators will also in...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 17 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04779216
Start Date
September 20 2021
End Date
November 17 2025
Last Update
December 16 2025
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114