Your session is about to expire
← Back to Search
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
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 belowSelect...
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:Select...
I have a history of heart disease but my recent ECG is normal or not concerning.
Select...
I have a condition affecting my intestines, such as celiac disease or Crohn's.
Select...
I have a new, untreated hormone gland disorder.
Select...
I have a condition affecting my body's mineral levels, like vitamin D deficiency or hyperparathyroidism.
Select...
I have not had a menstrual period for over a year, not due to pregnancy or breastfeeding.
Select...
I am on long-term blood thinners.
Select...
I have been taking more than 5 mg of prednisone or similar daily for over 3 months.
Select...
I am currently taking medication to stop new blood vessels from forming in my tumor.
Select...
My kidney function is reduced (eGFR below 60).
Select...
I have cancer, but not skin cancer that's been cured.
Select...
I haven't had major dental work in the last 3 months and don't need any in the next 2 years.
Select...
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Percent change in distal radius BMD by DXA
Structure of neck of femur
Percent change in lumbar spine BMD by DXA
+1 moreTrial 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.
Find a Location
Who is running the clinical trial?
Columbia UniversityLead Sponsor
1,448 Previous Clinical Trials
2,531,460 Total Patients Enrolled
AmgenIndustry Sponsor
1,392 Previous Clinical Trials
1,381,090 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.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of heart disease but my recent ECG is normal or not concerning.I have a condition affecting my intestines, such as celiac disease or Crohn's.I have a new, untreated hormone gland disorder.I have a condition affecting my body's mineral levels, like vitamin D deficiency or hyperparathyroidism.I am currently using or have a history of using specific medications like steroids, anticonvulsants, blood thinners, methotrexate, or drugs to stop my periods.I stopped my osteoporosis medication as required before joining the trial.Your hormone levels show that you are not in the early stage of menopause.I have not had a menstrual period for over a year, not due to pregnancy or breastfeeding.I am on long-term blood thinners.I agree to use highly effective birth control during the study.My body releases too much calcium in my urine and treatments haven't worked.I may have bone softening due to symptoms like bone pain when standing and high enzyme levels.I have been taking more than 5 mg of prednisone or similar daily for over 3 months.I am a woman aged 18-48, premenopausal, with regular periods and no osteoporosis.I had an eating disorder that resolved over 5 years ago, lasting less than a year and started after I was 20.I am currently taking medication to stop new blood vessels from forming in my tumor.My vitamin D levels were low but are now ≥30 ng/ml after treatment.I have not taken Depo Provera in the last 5 years, or I started it after age 20.I have had fractures from minor falls and my bone density scores are low.You are allergic to romosozumab or denosumab.Low levels of calcium in the blood.My kidney function is reduced (eGFR below 60).I have cancer, but not skin cancer that's been cured.I haven't had major dental work in the last 3 months and don't need any in the next 2 years.I am currently using blood thinners, but I don't have a history of blood clots.My liver tests are higher than normal.
Research Study Groups:
This trial has the following groups:- Group 1: Romosozumab followed by denosumab
Awards:
This trial has 2 awards, including:- 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.
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.
Share this study with friends
Copy Link
Messenger