Preserving Geriatric Muscle With an Osteoporosis Medication

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Susan L. Greenspan
Study ID
NCT06118905
Phase
PHASE4
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Denosumab 60 MG/ML — DRUG
    Subjects to receive Denosumab 60mg SQ and Zoledronic acid placebo IV
  • Zoledronic Acid 5Mg/Bag 100Ml Infusion — DRUG
    Subjects to receive Zoledronic Acid 5mg IV and Denosumab placebo

Study Details

Our goal is to demonstrate efficacy of the novel agent Denosumab to improve or preserve muscle health, strength, mobility and function in frail older adults.

Key Dates

Start date
Feb 8, 2024
Status verified
Feb 2026
Primary completion
Feb 28, 2029
Completion
Mar 31, 2029

Study Design

Enrollment
155 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Denosumab
    Denosumab 60mg SQ with placebo zoledronic acid
  • Active Comparator: Zoledronic acid
    Zoledronic acid 5mg IV with Denosumab placebo

Primary Outcome Measure

Knee extension strength change [ Time Frame: 12 Months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
St. Barnabas WoodlandsPittsburghPennsylvania16059
Joanie Gorman

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