Clinical trial NCT05666310: Muscle Impact of Treating Osteoporosis
Official title: The Impact of Osteoporosis Medications on Muscle Health in Older Adults
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Sarcopenia
Osteoporosis
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: The Claude D. Pepper Older Americans Independence Centers
name: National Institute on Aging (NIA)
First posted: 2022-12-27
Enrollment: 20
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Osteosarcopenia is a geriatric musculoskeletal syndrome characterized by co-existence of osteoporosis and sarcopenia (low skeletal muscle mass, strength, and/or functional capacity). There is strong evidence of overlap between the pathophysiology of osteoporosis and sarcopenia (muscle-bone crosstalk). This research plan will further explore the relationship between bone and muscle, and provide new information about effect of osteoporosis medications on muscle health in older adults who are under treatment for osteoporosis.


Eligibility criteria: Inclusion Criteria:

Ambulatory adults age ≥65 years including those using assistive devices to maximize generalizability, if they have criteria for treating osteoporosis including:

1. Osteoporosis by axial bone density (spine, hip or forearm BMD T-score ≤-2.5 SD) or
2. A previous adult fragility fracture of the spine or hip or
3. Would be treated based on FRAX National Osteoporosis Foundation treatment thresholds of a 10-year risk of ≥ 20% for a major osteoporotic fracture or ≥ 3% for hip fracture using femoral neck BMD.

Exclusion Criteria:

1. Patients with a calculated creatinine clearance \< 35 ml/min or
2. Who have a contraindication for bisphosphonates or denosumab or
3. Those who are scheduled for a tooth extraction to avoid jaw osteonecrosis or
4. Subjects with severe liver disease or
5. Those who have been on oral bisphosphonates for the past 1 year and intravenous bisphosphonates for the past 2 years prior to the study or
6. Men

Primary outcomes:
measure: Percentage change from baseline in muscle mass (kg) measured by D3-Creatine
timeFrame: Baseline vs Month 12
measure: Percentage change from baseline in appendicular lean mass (ALM/body mass index)
timeFrame: Baseline vs Month 12
measure: Percentage change from baseline in trabecular bone score (TBS)
timeFrame: Baseline vs Month 12
measure: Percentage change from baseline in bone mineral density (BMD) (g/cm²)
timeFrame: Baseline vs Month 12
measure: Percentage change from baseline in grip strength (kgf)
timeFrame: Baseline vs Month 12
measure: Percentage change from baseline in gait speed (m/s)
timeFrame: Baseline vs Month 12
measure: Percentage change from baseline in rectus femoris muscle thickness (cm)
timeFrame: Baseline vs Month 12
measure: Percentage change from baseline in rectus femoris muscle cross-sectional surface area (cm²)
timeFrame: Baseline vs Month 12
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Nami Safai Haeri, MD
role: PRINCIPAL_INVESTIGATOR
References: