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Monoclonal Antibodies

Osteoporosis Medication for Muscle Health in Older Adults

Phase 4
Recruiting
Research Sponsored by Susan L. Greenspan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ambulatory male and female residents with osteoporosis or low bone mass (at risk for fracture) age 65 and older will be considered if: 1) they reside in an institution (nursing home, assisted living facility or senior community) and; 2) they have osteoporosis as diagnosed by a) BMD (spine, hip or forearm BMD T-score ≤ -2.5 SD), b) a previous adult fragility spine or hip fracture, or c) have osteopenia but would be treated based on FRAX and the BHOF treatment thresholds of a 10-year major fracture risk of ≥ 20% or ≥ 3% hip fracture risk using femoral neck BMD.
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Drug Has Already Been Approved

Summary

This trial aims to show that a new medication called Denosumab can help older adults who are weak and frail by improving their muscle health, strength, mobility, and overall function.

Who is the study for?
This trial is for ambulatory men and women aged 65 or older living in institutions like nursing homes, who have osteoporosis or low bone mass at risk of fractures. They must have a diagnosis based on bone density scores, history of certain fractures, or high fracture risk as per specific criteria.
What is being tested?
The study tests the effectiveness of Denosumab in improving muscle health and strength compared to Zoledronic Acid in frail elderly adults with osteoporosis. It aims to see if Denosumab can help maintain mobility and function.
What are the potential side effects?
Potential side effects may include skin infections around the injection site for Denosumab, low calcium levels, joint pain, general weakness, and rarely jawbone problems. Zoledronic Acid might cause flu-like symptoms, kidney issues, muscle pain, and also rare jawbone complications.

Eligibility Criteria

Inclusion Criteria

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

Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Knee extension strength change

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
Experimental Treatment
Active Control
Group I: DenosumabExperimental Treatment1 Intervention
Denosumab 60mg SQ with placebo zoledronic acid
Group II: Zoledronic acidActive Control1 Intervention
Zoledronic acid 5mg IV with Denosumab placebo

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Who is running the clinical trial?

Susan L. GreenspanLead Sponsor
5 Previous Clinical Trials
833 Total Patients Enrolled
5 Trials studying Osteoporosis
833 Patients Enrolled for Osteoporosis
~165 spots leftby Apr 2027
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