Print

Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 20 Years and 60 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)
Masking Description
Double Blind

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Active Romosozumab 210mg Injection 		Romosozumab 210mg injection monthly for 12 months. Alendronate 70mg PO weekly starting at Month 12 through 24 months.
  • Drug: Romosozumab Prefilled Syringe
    Romosozumab 210mg Injection monthly for 12 months
  • Drug: Alendronate 70Mg Tab
    Alendronate 70mg PO weekly starting at 12 months through 24 months.
Placebo Comparator
Placebo 		Placebo injection monthly for 12 months. Alendronate 70mg PO weekly starting at Month 12 through 24 months.
  • Drug: Placebo
    Placebo Injection monthly for 12 months
  • Drug: Alendronate 70Mg Tab
    Alendronate 70mg PO weekly starting at 12 months through 24 months.

More Details

Status
Active, not recruiting
Sponsor
Karen Klahr Miller, MD

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.