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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months, 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months, 24 months
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 • NCT0329214615%
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
1,433 Previous Clinical Trials
1,395,112 Total Patients Enrolled
1 Trials studying Anorexia Nervosa
30 Patients Enrolled for Anorexia Nervosa
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree to use a highly effective birth control method.I have jawbone damage or risk factors like recent major dental work, poor oral hygiene, gum/dental disease, or I'm using corticosteroids.I haven't taken any bone-affecting drugs in the last 3 months, except for birth control or estrogen.I have a weak immune system or am taking medication to suppress my immunity.I am female.I have been diagnosed with osteomalacia.I have diabetes.I have a condition that affects my bones, like thyroid issues, Cushing's, or kidney problems.You have a very low body weight for your height.I have not had a heart attack or stroke in the past year.I am between 20 and 60 years old and my bones have stopped growing.My kidney function is low.You are allergic or sensitive to calcium or vitamin D supplements.Your blood test shows that your ALT levels are more than three times higher than the normal range.Your LDL cholesterol level is higher than 190 mg/dL.I plan to have a dental surgery within the next 2 years.I have been diagnosed with anorexia nervosa or atypical anorexia nervosa.Low levels of calcium in the bloodYour vitamin D and calcium levels are within the normal range.I have been diagnosed with Paget's disease of bone.Your bone density score is lower than -1.0You are currently misusing drugs or alcohol.Your blood potassium level is less than 3.0 meq/L.Your blood test shows low levels of magnesium.I have had cancer before.I have been diagnosed with anorexia nervosa or atypical anorexia.I am female.I have not had a dental check-up in over a year.Your bone density test score is lower than -1.0.I am between 20 and 60 years old and my bones have stopped growing.I have been diagnosed with anorexia nervosa or atypical anorexia nervosa.
Research Study Groups:
This trial has the following groups:- Group 1: Active Romosozumab 210mg Injection
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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