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Monoclonal Antibodies

Anabolic Therapy for Osteoporosis

Phase 4
Waitlist Available
Led By Benjamin Leder, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Stage 4 or 5 chronic kidney disease (GFR less than 30)
Current use or use in the past 12 months of oral bisphosphonates or denosumab
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 0 to 12
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Drug Has Already Been Approved

Summary

This trial will compare two different medications to see which is more effective in the treatment of osteoporosis.

Who is the study for?
This trial is for postmenopausal women at high risk of fracture. Participants must not have severe kidney disease, uncontrolled skin conditions, very low or high calcium levels, certain bone diseases other than osteoporosis, recent heart issues, or a history of significant lung disease. They should not have used specific osteoporosis treatments recently and must not be currently abusing substances.
What is being tested?
The study compares two FDA-approved medications for treating osteoporosis: Denosumab and Romosozumab. It aims to understand their effects in preventing fractures in postmenopausal women who are at a higher risk.
What are the potential side effects?
Possible side effects include skin reactions at the injection site, low calcium levels in the blood (hypocalcemia), infections including those of the ear and urinary tract, joint pain (arthralgia), headache, nausea or vomiting.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My kidney function is severely reduced.
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I have used oral bisphosphonates or denosumab in the last year.
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I have a serious lung condition.
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I have used romosozumab or strontium before.
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I have had unstable chest pain or a mini-stroke in the last year.
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I have used steroids for more than 2 weeks in the last 6 months.
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I currently have atrial fibrillation.
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I have a bone condition that is not osteoporosis.
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I have had cancer before, but not skin cancer.
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I have not used teriparatide, abaloparatide, or injectable bisphosphonates in the last 3 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 0 to 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 0 to 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Total hip areal bone mineral density

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Active Control
Group I: RomosozumabActive Control1 Intervention
Group II: Romosozumab and denosumabActive Control2 Interventions

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
3,006 Previous Clinical Trials
13,307,232 Total Patients Enrolled
22 Trials studying Osteoporosis
1,439 Patients Enrolled for Osteoporosis
Benjamin Leder, MDPrincipal InvestigatorMass. General Hospital
4 Previous Clinical Trials
179 Total Patients Enrolled
4 Trials studying Osteoporosis
179 Patients Enrolled for Osteoporosis

Media Library

Denosumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05010590 — Phase 4
Osteoporosis Research Study Groups: Romosozumab, Romosozumab and denosumab
Osteoporosis Clinical Trial 2023: Denosumab Highlights & Side Effects. Trial Name: NCT05010590 — Phase 4
Denosumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05010590 — Phase 4
~14 spots leftby Nov 2025
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