Muscle Impact of Treating Osteoporosis

Phase 4

Active, not recruiting

• Conditions: Sarcopenia; Osteoporosis
• Interventions: Drug: Zoledronic Acid; Drug: Denosumab; Other: Zoledronic Acid Placebo; Other: Denosumab Placebo

• Registration Number: NCT05666310
• Lead Sponsor: Nami Safai Haeri

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-15
• Study First Submitted QC: 2022-12-22
• Study First Posted: 2022-12-27
• Study Start: 2023-02-14
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-04
• Last Update Posted: 2025-01-07
• Primary Completion: 2025-07-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Denosumab	Zoledronic Acid Placebo	-
Zoledronic Acid	Denosumab Placebo	-
Zoledronic Acid	Zoledronic Acid	-
Denosumab	Denosumab	-

Primary Outcome Measures

Name	Time	Method
Percentage change from baseline in appendicular lean mass (ALM/body mass index)	Baseline vs Month 12	Appendicular lean mass is measured by whole body DXA scan and is an index of skeletal muscle mass
Percentage change from baseline in gait speed (m/s)	Baseline vs Month 12	Gait speed is a measure of muscle function and will be measured by standard 4 meter gait speed test
Percentage change from baseline in muscle mass (kg) measured by D3-Creatine	Baseline vs Month 12	D3-Creatine dilution method is a novel method to measure muscle mass
Percentage change from baseline in bone mineral density (BMD) (g/cm²)	Baseline vs Month 12	BMD is measured by a DXA scan system and a higher BMD is correlated with lower fracture risk
Percentage change from baseline in rectus femoris muscle thickness (cm)	Baseline vs Month 12	This variable will be measured by ultrasound
Percentage change from baseline in rectus femoris muscle cross-sectional surface area (cm²)	Baseline vs Month 12	This variable will be measured by ultrasound
Percentage change from baseline in trabecular bone score (TBS)	Baseline vs Month 12	TBS is measure of bone microarchitecture and is measured by a DXA system. A value of ≥ 1.35 indicates a normal architecture while TBS ≤ 1.20 indicates degraded microarchitecture
Percentage change from baseline in grip strength (kgf)	Baseline vs Month 12	Grip strength is measure of muscle strength and will be measured by a standard hand dynamometer

Trial Locations

Locations (1)

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States