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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
Must agree to use highly effective contraception throughout the period of study drug administration. Highly effective contraception includes methods considered by the CDC to be >99% effective (e.g. vasectomized partner, tubal ligation, hysterectomy, IUD) as well as a combination of barrier method (condoms) with hormonal contraception considered to be > 90% effective (oral contraceptive pill, patch or ring). Systemic progestin only methods (oral or implanted) are not included due to their effect on systemic estrogen levels and thus potential effects on bone health in this premenopausal population.
Premenopausal women, aged 18-48, with regular menses and no historical or biochemical secondary cause of osteoporosis; the lower age limit is to ensure epiphyses are fused, the upper to make it less likely that women will enter menopause during the study. All subjects under age 25 will be screened (bone age radiograph) prior to enrollment to rule out open epiphyses.
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

Study 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.Check my eligibility
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.See study design
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 agree to use highly effective birth control during the study.
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I am a woman aged 18-48, premenopausal, with regular periods and no osteoporosis.
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I have had fractures from minor falls and my bone density scores are low.

Timeline

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

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 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.

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,419 Previous Clinical Trials
2,472,352 Total Patients Enrolled
AmgenIndustry Sponsor
1,351 Previous Clinical Trials
1,376,109 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

Denosumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04800367 — Phase 2
Idiopathic Osteoporosis Research Study Groups: Romosozumab followed by denosumab
Idiopathic Osteoporosis Clinical Trial 2023: Denosumab Highlights & Side Effects. Trial Name: NCT04800367 — Phase 2
Denosumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04800367 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the Denosumab 60 MG/ML Prefilled Syringe [Prolia] have authorization from the FDA?

"Denosumab 60 MG/ML Prefilled Syringe [Prolia] has been evaluated to a rating of 2 due to the presence of some evidence indicating its safety, however no efficacy data exists at this time."

Answered by AI

What medical conditions is Denosumab 60 MG/ML Prefilled Syringe [Prolia] commonly prescribed for?

"Denosumab 60 MG/ML Prefilled Syringe [Prolia] is commonly used to address skeletally mature patients. Beyond this, it has been proven effective for managing androgens, malignant neoplasms, and osteoporosis."

Answered by AI

Does this experiment accept volunteers aged 25 and older?

"This study only admits individuals aged 18 to 45. Separately, 20 trials are available for those younger than 18 and 165 studies exist for seniors over the age of 65."

Answered by AI

Is there any evidence of prior research on Denosumab 60 MG/ML Prefilled Syringe [Prolia]?

"Presently, 55 clinical trials are in progress testing Denosumab 60 MG/ML Prefilled Syringe [Prolia], 14 of which have arrived at Phase 3. While the bulk of studies lie in Izmir and Madrid, 538 sites across the world are currently investigating this therapeutical option."

Answered by AI

Is this clinical endeavor currently accepting new participants?

"Indeed, clinicaltrials.gov holds evidence that this study is actively searching for volunteers; it was originally posted on March 12th of 2021 and updated as recently as October 5th 2022. 30 participants are required from a single location to participate in the investigation."

Answered by AI

What is the enrollment scope of this investigation?

"Affirmative. The data available on clinicaltrials.gov verifies that this research study, which had its initial posting on March 12th 2021, is currently recruiting patients. Approximately 30 participants need to be recruited from only one medical centre."

Answered by AI

Does my profile qualify me to participate in this investigation?

"This clinical trial is looking for 30 premenopausal women, aged 18-48 with regular menses and no secondary cause of osteoporosis. All participants under the age of 25 must undergo a bone age radiograph to ensure epiphyses are fused. Furthermore, all potential patients must have an adult fracture from low trauma equivalent to a fall from standing height or less as well as T-score/Z-score ≤ -1.5 at LS, TH or FN sites before being accepted into the study. Lastly, it is necessary that those participating use highly effective contraception methods throughout the duration of this trial administration (vasectom"

Answered by AI
~8 spots leftby Mar 2025