← Back to Search

Monoclonal Antibodies

Romosozumab for Anorexia Nervosa

Phase 3
Waitlist Available
Research Sponsored by Karen Klahr Miller, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female
Age 20-60 years, skeletally mature with closed epiphyses
Must not have
Any disease known to affect bone, including untreated thyroid dysfunction, Cushing's or renal failure
Immunodeficiency or taking immunosuppressive therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months, 24 months
Awards & highlights
Pivotal Trial

Summary

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.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include reactions where the medication is injected, increased risk of infections due to immune system effects, muscle pain or spasms related to changes in minerals like calcium and magnesium from treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am female.
Select...
I am between 20 and 60 years old and my bones have stopped growing.
Select...
I have been diagnosed with anorexia nervosa or atypical anorexia nervosa.
Select...
I agree to use a highly effective birth control method.
Select...
I have been diagnosed with anorexia nervosa or atypical anorexia.
Select...
I am female.
Select...
I am between 20 and 60 years old and my bones have stopped growing.
Select...
I have been diagnosed with anorexia nervosa or atypical anorexia nervosa.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a condition that affects my bones, like thyroid issues, Cushing's, or kidney problems.
Select...
I have a weak immune system or am taking medication to suppress my immunity.
Select...
My kidney function is low.
Select...
I have diabetes.
Select...
I have had cancer before.
Select...
I have been diagnosed with Paget's disease of bone.
Select...
I have been diagnosed with osteomalacia.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months, 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months, 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Change in bone density

Side effects data

From 2021 Phase 3 trial • 30 Patients • NCT03292146
15%
constipation
5%
COVID-19
5%
nausea/stomach pain/bloating
5%
bone fracture
5%
Keratitis
5%
C. difficile
5%
Disc degeneration and herniation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Denosumab (0-12 Months) Followed by Alendronate (12-24 Months)
Placebo (0-12 Months) Followed by Alendronate (12-24 Months)

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active Romosozumab 210mg InjectionExperimental Treatment2 Interventions
Romosozumab 210mg injection monthly for 12 months. Alendronate 70mg PO weekly starting at Month 12 through 24 months.
Group II: PlaceboPlacebo Group2 Interventions
Placebo injection monthly for 12 months. Alendronate 70mg PO weekly starting at Month 12 through 24 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Alendronate 70Mg Tab
2019
Completed Phase 3
~120

Find a Location

Who is running the clinical trial?

Karen Klahr Miller, MDLead Sponsor
AmgenIndustry Sponsor
1,442 Previous Clinical Trials
1,397,714 Total Patients Enrolled
1 Trials studying Anorexia Nervosa
30 Patients Enrolled for Anorexia Nervosa

Media Library

Romosozumab Prefilled Syringe (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04779216 — Phase 3
Anorexia Nervosa Research Study Groups: Active Romosozumab 210mg Injection, Placebo
Anorexia Nervosa Clinical Trial 2023: Romosozumab Prefilled Syringe Highlights & Side Effects. Trial Name: NCT04779216 — Phase 3
Romosozumab Prefilled Syringe (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04779216 — Phase 3
~7 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top