Using an osteoporosis medication to improve muscle health in older adults

Preserving Geriatric Muscle With an Osteoporosis Medication

This study is testing if an osteoporosis medication called Denosumab can help frail older adults improve their muscle strength and reduce the risk of falls.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 155 (estimated)
• Ages: 65 Years and up
• Sex: All
• Sponsor: University of Pittsburgh (Academic / other)
• Drugs / interventions: Denosumab, romosozumab, DEMAB
• Locations: 1 site (Pittsburgh, Pennsylvania)
• Trial ID: NCT06118905 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of Denosumab, an osteoporosis medication, in enhancing muscle health, strength, mobility, and function among frail older adults living in senior communities. The study addresses the critical issue of falls in this population, which are a leading cause of morbidity and mortality. By focusing on the relationship between muscle and bone health, the trial seeks to demonstrate that Denosumab can reduce the risk of falls and fractures in individuals with osteoporosis. Participants will receive Denosumab or an alternative treatment and will be monitored for improvements in their physical capabilities.

Who should consider this trial

Good fit: Ideal candidates are ambulatory men and women aged 65 and older with osteoporosis or low bone mass residing in nursing homes, assisted living facilities, or senior communities.

Not a fit: Patients with subacute illnesses or a life expectancy of less than one year, as well as those currently on related osteoporosis therapies, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly reduce the incidence of falls and fractures in frail older adults, improving their quality of life.

How similar studies have performed: Previous studies have shown promising results with Denosumab in reducing falls and fractures, indicating potential success for this approach.

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 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.

Where this trial is running

Pittsburgh, Pennsylvania

• St. Barnabas Woodlands — Pittsburgh, Pennsylvania, United States (Recruiting)

Study contacts

• Study coordinator: Susan Greenspan, MD

Conditions Osteoporosis