Romosozumab for Anorexia Nervosa

Overseen By Erinne Meenaghan, NP

Age: 18 - 65

Sex: Female

Trial Phase: Phase 3

Sponsor: Karen Klahr Miller, MD

Must not be taking: Bisphosphonates, Immunosuppressants

Disqualifiers: BMI <17, Diabetes, Substance abuse, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

30 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop taking any medication known to affect bone metabolism at least 3 months before participating, except for oral contraceptives or other forms of estrogen. If you are taking bisphosphonates, they must be discontinued for at least one year before joining the trial.

How is the drug Romosozumab unique for treating anorexia nervosa?

Romosozumab is unique for treating anorexia nervosa because it is primarily known for its use in treating osteoporosis by increasing bone formation and decreasing bone resorption, which may help address bone density issues in anorexia nervosa patients. ^{1 2 3 4 5}

What is the purpose of this trial?

This trial tests if romosozumab can help women with anorexia nervosa build stronger bones over a year, followed by alendronate to maintain the strength. The goal is to see if this combination improves bone health. Romosozumab is a treatment that both increases bone formation and decreases bone breakdown, primarily used to reduce fracture risk in postmenopausal women with osteoporosis.

Eligibility Criteria

Women aged 20-60 with anorexia nervosa or atypical anorexia, having low bone density (BMD T-score < -1.0), normal vitamin D and calcium levels, who've had a dental check-up in the past year. They must not be on medications affecting bone metabolism recently, have no major illnesses like diabetes or untreated thyroid issues, and agree to use effective contraception if of reproductive age.

Inclusion Criteria

I agree to use a highly effective birth control method.

Dental check-up within the past year

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

Exclusion Criteria

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

I have jawbone damage or risk factors like recent major dental work, poor oral hygiene, gum/dental disease, or I'm using corticosteroids.

Pregnant, planning to become pregnant within 7 months after the end of treatment, and/or breastfeeding

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive romosozumab or placebo injections monthly for 12 months

12 months

Extension

Participants receive open-label alendronate 70 mg weekly for 12 months

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• Alendronate 70Mg Tab
• Placebo
• Romosozumab Prefilled Syringe

Trial Overview The trial is testing Romosozumab's effects on increasing bone mineral density (BMD) against a placebo in women with anorexia nervosa over 12 months. After this period, all participants will receive Alendronate for another year to see if it helps maintain or increase BMD further.

Participant Groups

Group I: Active Romosozumab 210mg Injection Experimental Treatment 2 Interventions

Romosozumab 210mg injection monthly for 12 months. Alendronate 70mg PO weekly starting at Month 12 through 24 months.

Group II: Placebo Placebo Group 2 Interventions

Placebo injection monthly for 12 months. Alendronate 70mg PO weekly starting at Month 12 through 24 months.

Who Is Running the Clinical Trial?

Karen Klahr Miller, MD

Lead Sponsor

Trials

1

Recruited

30+

Amgen

Industry Sponsor

Trials

1,508

Recruited

1,433,000+

Founded

1980

Headquarters

Thousand Oaks, USA

Known For

Human Therapeutics

Top Products

Enbrel, Prolia, Neulasta, Otezla

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton

Amgen

Chief Medical Officer since 2023

MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London

Findings from Research

Dasiglucagon is a safe and effective treatment for severe hypoglycemia in type 1 diabetes, showing a similar safety profile to reconstituted glucagon with no serious adverse events reported in trials involving adults.

In terms of efficacy, dasiglucagon provided a rapid recovery from insulin-induced hypoglycemia, with a median recovery time of 10 minutes, significantly faster than the 40 minutes observed with placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated safety and efficacy analysis of dasiglucagon for the treatment of severe hypoglycaemia in individuals with type 1 diabetes. Heller, S., Battelino, T., Bailey, TS., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

The Pharmacokinetics and Relative Bioavailability of Mepolizumab 100 mg Liquid Formulation Administered Subcutaneously to Healthy Participants: A Randomized Trial. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Nasal glucagon as a viable alternative for treating insulin-induced hypoglycaemia in Japanese patients with type 1 or type 2 diabetes: A phase 3 randomized crossover study. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Integrated safety and efficacy analysis of dasiglucagon for the treatment of severe hypoglycaemia in individuals with type 1 diabetes. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Glucagon Administration by Nasal and Intramuscular Routes in Adults With Type 1 Diabetes During Insulin-Induced Hypoglycaemia: A Randomised, Open-Label, Crossover Study. [2021]

5. Australia pubmed.ncbi.nlm.nih.gov

Mini-dose glucagon rescue for mild hypoglycaemia in children with type 1 diabetes: the Brisbane experience. [2022]