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RECRUITINGPhase 4INTERVENTIONAL

Preserving Geriatric Muscle With an Osteoporosis Medication

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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. Who Should NOT Join This Trial: 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 history of hypocalcemia or contraindication for treatment or those who are on systemic glucocorticoids that may lower muscle strength. We will screen for these conditions by detailed history, chart review, and baseline laboratory analyses. Participants with 25-hydroxyvitamin D levels \<25 ng/mL will be treated with vitamin D 50,000 IU/wk for 8 weeks. The patient will be enrolled if the follow-up vitamin D level is 25 ng/mL or more. Patients will be allowed to continue on anticonvulsants because use is common in this population. Women on hormone replacement, raloxifene, or residents prescribed protective hip pads will be allowed to participate and continue on these therapies. We will suggest participants stop calcitonin due to cancer concerns. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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 history of hypocalcemia or contraindication for treatment or those who are on systemic glucocorticoids that may lower muscle strength. We will screen for these conditions by detailed history, chart review, and baseline laboratory analyses. Participants with 25-hydroxyvitamin D levels \<25 ng/mL will be treated with vitamin D 50,000 IU/wk for 8 weeks. The patient will be enrolled if the follow-up vitamin D level is 25 ng/mL or more. Patients will be allowed to continue on anticonvulsants because use is common in this population. Women on hormone replacement, raloxifene, or residents prescribed protective hip pads will be allowed to participate and continue on these therapies. We will suggest participants stop calcitonin due to cancer concerns.

Treatments Being Tested

DRUG

Denosumab 60 MG/ML

Subjects to receive Denosumab 60mg SQ and Zoledronic acid placebo IV

DRUG

Zoledronic Acid 5Mg/Bag 100Ml Infusion

Subjects to receive Zoledronic Acid 5mg IV and Denosumab placebo

Locations (1)

St. Barnabas Woodlands
Pittsburgh, Pennsylvania, United States