Effects of Romosozumab on Bone Density in Women With Anorexia Nervosa

Anorexia Nervosa Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04779216
• Other study ID #: 2020P000329
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: September 20, 2021
• Est. completion date: September 2025

Study information

• Verified date: March 2024
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: September 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 60 Years

Eligibility

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), 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

Exclusion Criteria:

• Body mass index (BMI) <17 kg/m2

• 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

• 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

• 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 7 months after the end of treatment, and/or breastfeeding

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa
• Bone Density, Low
• Bone Diseases, Metabolic
• Bone Loss
• Eating Disorders
• Feeding and Eating Disorders

Intervention

Drug:
• Romosozumab Prefilled Syringe
Romosozumab 210mg Injection monthly for 12 months
• Placebo
Placebo Injection monthly for 12 months
• Alendronate 70Mg Tab
Alendronate 70mg PO weekly starting at 12 months through 24 months.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Karen Klahr Miller, MD	Amgen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in bone density	Change in bone density	12 months
Secondary	Change in bone density	Change in bone density	6 months, 24 months