Preserving Geriatric Muscle With an Osteoporosis Medication
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:
• 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.
Locations
United States
Pennsylvania
St. Barnabas Woodlands
RECRUITING
Pittsburgh
Contact Information
Primary
Susan Greenspan, MD
greenspn@pitt.edu
+14128554806
Backup
Nicholas Gatto, BS
NJG29@PITT.EDU
4126089525
Time Frame
Start Date: 2024-02-08
Estimated Completion Date: 2029-03-31
Participants
Target number of participants: 155
Treatments
Experimental: Denosumab
Denosumab 60mg SQ with placebo zoledronic acid
Active_comparator: Zoledronic acid
Zoledronic acid 5mg IV with Denosumab placebo
Related Therapeutic Areas
Sponsors
Leads: Susan L. Greenspan