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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called romosozumab to determine if it can improve bone health in women with anorexia nervosa. The research aims to discover whether romosozumab, followed by alendronate, can increase bone mineral density and enhance bone structure. Suitable candidates for this trial include women with anorexia nervosa, a history of bone weakness, and normal vitamin D levels. Participants will receive either romosozumab injections or a placebo for 12 months, followed by alendronate pills for another 12 months. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that romosozumab is generally safe for people, including those with anorexia nervosa. Studies have found that it can significantly improve bone strength. Some participants experienced side effects, usually mild, such as joint pain or redness and swelling at the injection site.

Romosozumab already has FDA approval to increase bone density in other conditions, indicating a known safety record. However, it is still under study specifically for people with anorexia nervosa to ensure its safety and effectiveness for them. Always consult a healthcare provider with any questions about how this treatment might work. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for anorexia nervosa?

Unlike the standard treatments for anorexia nervosa, which often focus on nutritional rehabilitation and psychological therapy, Romosozumab targets bone health directly. Romosozumab is a monoclonal antibody that works by inhibiting sclerostin, a protein that affects bone formation and resorption, potentially improving bone density—a common issue in individuals with anorexia nervosa. Researchers are excited about Romosozumab because it provides a novel approach to addressing the bone complications associated with this condition, offering a dual benefit alongside standard care.

What evidence suggests that romosozumab might be an effective treatment for anorexia nervosa?

Research has shown that romosozumab, which participants in this trial may receive, can increase bone strength in women with anorexia nervosa. One study found that taking romosozumab for 12 months significantly improved bone density in the spine, hip, and upper thigh. Additionally, it increased signs of new bone growth and decreased signs of bone loss. These positive results suggest that romosozumab may improve bone health in women dealing with anorexia nervosa. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

Citations

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clinicaltrials.gov

clinicaltrials.gov/study/NCT04779216

Effects of Romosozumab on Bone Density in Women with ...

The investigators hypothesize that 12 months of romosozumab administration will result in an increase in bone mineral density, increase in markers of bone ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10874744/

Effect of romosozumab in premenopausal women with ...

This study aims to investigate the effects of romosozumab on BMD and bone metabolism. ... Long-term outcome of anorexia nervosa in a prospective 21-year follow-up ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S2352187224000706

Case Report Romosuzumab used to treat a 29-year-old ...

Based on our findings, 12 months of romosozumab treatment led to a significant increase in BMD values in the lumbar spine, femoral neck, and total hip of our AN ...

4.

rally.massgeneralbrigham.org

rally.massgeneralbrigham.org/study/romo

Bone Health Study Seeking Women with Disordered Eating

The goal of this study is to evaluate the effect of two medications on bone health in women with disordered eating. We hope to provide more targeted ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12545529/

SAT-805 Romosozumab Increases Spine and Hip Bone ...

SAT-805 Romosozumab Increases Spine and Hip Bone Mineral Density in Women With Anorexia Nervosa ... effects model using 0, 6 and 12-month data. At ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12321915/

Medication for bone loss in female patients with anorexia ...

The aims of this systematic review were to review current evidence on the medication used to prevent and treat low BMD in patients with AN, as ...

7.

mayoclinic.org

mayoclinic.org/drugs-supplements/romosozumab-aqqg-subcutaneous-route/description/drg-20461345

Romosozumab-aqqg (subcutaneous route) - Side effects & ...

Safety and efficacy have not been established. Geriatric. Appropriate studies performed to date have not demonstrated geriatric-specific ...