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Recruiting Phase 4 NCT06118905

Preserving Geriatric Muscle With an Osteoporosis Medication

Trial Parameters

Condition Osteoporosis
Sponsor Susan L. Greenspan
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 155
Sex ALL
Min Age 65 Years
Max Age N/A
Start Date 2024-02-08
Completion 2029-02-28
Interventions
Denosumab 60 MG/MLZoledronic Acid 5Mg/Bag 100Ml Infusion

Brief 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 Criteria

Inclusion Criteria: 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. Exclusion Criteria: We will exclude residents with subacute illnesses surviving or those with life expectancy \<1 year. We will exclude those currently on a related therapy (including a bisphosphonate, Denosumab, teriparatide, abaloparatide, or romosozumab) or who have been on a bisphosphonate for \>1 year during the previous 2 years because some bisphosphonates are long acting. We will exclude subjects with a

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