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Monoclonal Antibodies

Denosumab for Osteoporosis

Phase 4
Waitlist Available
Led By William A Bauman, M.D.
Research Sponsored by James J. Peters Veterans Affairs Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1, 3, 6, 12, and 18 months after denosumab administration
Awards & highlights
All Individual Drugs Already Approved
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial is testing Denosumab, a medication that prevents bone loss, in patients with acute spinal cord injury who experience severe bone weakening. The drug works by blocking a protein that causes bones to break down, helping to maintain their strength.

Eligible Conditions
  • Osteoporosis
  • Spinal Cord Injury

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 12, and 18 months after denosumab administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 12, and 18 months after denosumab administration for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Bone mineral density (BMD) of the distal femur
Secondary study objectives
Bone microarchitecture of the distal femur and proximal tibia.

Side effects data

From 2022 Phase 4 trial • 37 Patients • NCT04026256
44%
joint pain
22%
nausea
22%
propagation of fracture at biopsy site
11%
dizziness
11%
rhinorrhea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Denosumab Only
Teriparatide Only
Denosumab and Teriparatide

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.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
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: DenosumabExperimental Treatment1 Intervention
A group of participants will be randomized to the experimental group and will have Denosumab (Prolia, 60 mg SC) administered at baseline, 6 and 12 months.
Group II: PlaceboPlacebo Group1 Intervention
A group of participants will be randomized to the placebo group and will receive the identical volume of normal saline at parallel time points.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Denosumab
FDA approved

Find a Location

Who is running the clinical trial?

James J. Peters Veterans Affairs Medical CenterLead Sponsor
57 Previous Clinical Trials
2,856 Total Patients Enrolled
4 Trials studying Osteoporosis
105 Patients Enrolled for Osteoporosis
Kessler Institute for RehabilitationIndustry Sponsor
22 Previous Clinical Trials
1,141 Total Patients Enrolled
4 Trials studying Osteoporosis
105 Patients Enrolled for Osteoporosis
William A Bauman, M.D.Principal InvestigatorJames J. Peters VA Medical Center
2 Previous Clinical Trials
26 Total Patients Enrolled
2 Trials studying Osteoporosis
26 Patients Enrolled for Osteoporosis
~2 spots leftby Nov 2025
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