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Monoclonal Antibodies

Romosozumab + Denosumab for Osteoporosis

Phase 2

Recruiting

Led By Adi Cohen, MD

Research Sponsored by Columbia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Documented adult fractures judged to be low-trauma (equivalent to a fall from a standing height or less) and T-score or Z-score ≤ -1.5 at the LS, TH or FN.

Be between 18 and 65 years old

Must not have

Any cardiovascular disease: history of myocardial infarction (MI) or stroke. Normal electrocardiogram (ECG) or ECG with no clinically significant abnormality is required at study entry.

Intestinal disorders including but not limited to celiac disease, pancreatic insufficiency, Crohn Disease or ulcerative colitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6 month, 12 month, 18 month, 24 month

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is testing a new osteoporosis treatment in premenopausal women to see if it is more effective than the current standard of care.

Who is the study for?

This trial is for premenopausal women aged 18-48 with idiopathic osteoporosis, regular menstrual cycles, and no secondary cause of bone loss. Participants must have had low-trauma fractures and a T-score or Z-score ≤ -1.5 at certain bone sites. They should agree to highly effective contraception during the study.

What is being tested?

The study tests if romosozumab improves bone mass in premenopausal women with osteoporosis better than teriparatide does. It involves giving participants romosozumab monthly for a year followed by denosumab every six months for another year, comparing their results to historical controls.

What are the potential side effects?

Possible side effects include reactions at the injection site, muscle pain, headache, joint pain, and possibly increased risk of heart problems or stroke. There's also a concern about potential harm to bones like unusual fractures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had fractures from minor falls and my bone density scores are low.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of heart disease but my recent ECG is normal or not concerning.

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I have a condition affecting my intestines, such as celiac disease or Crohn's.

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I have a new, untreated hormone gland disorder.

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I have a condition affecting my body's mineral levels, like vitamin D deficiency or hyperparathyroidism.

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I have not had a menstrual period for over a year, not due to pregnancy or breastfeeding.

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I am on long-term blood thinners.

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I have been taking more than 5 mg of prednisone or similar daily for over 3 months.

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I am currently taking medication to stop new blood vessels from forming in my tumor.

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My kidney function is reduced (eGFR below 60).

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I have cancer, but not skin cancer that's been cured.

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I haven't had major dental work in the last 3 months and don't need any in the next 2 years.

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My liver tests are higher than normal.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6 month, 12 month, 18 month, 24 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6 month, 12 month, 18 month, 24 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 month, 12 month, 18 month, 24 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Percent change in distal radius BMD by DXA

Structure of neck of femur

Percent change in lumbar spine BMD by DXA

+1 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Romosozumab followed by denosumabExperimental Treatment2 Interventions

Romosozumab 210 mg subcutaneous injection, once a month for 12 months followed by denosumab 60 mg subcutaneous injection, once every six months for 12 months.

0 / 13Eligibility criteria met

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor

1,486 Previous Clinical Trials

2,655,286 Total Patients Enrolled

AmgenIndustry Sponsor

1,433 Previous Clinical Trials

1,395,112 Total Patients Enrolled

Adi Cohen, MD4.04 ReviewsPrincipal Investigator - Columbia University

Columbia University

3 Previous Clinical Trials

96 Total Patients Enrolled

5Patient Review

Dr. Cohen has been extremely helpful, especially given the complexity of my condition. I never feel rushed during our appointments and appreciate how willing she is to help me understand my options. I would recommend her to anyone.