Muscle Impact of Treating Osteoporosis

Osteoporosis Clinical Trial

— MITO  

Official title:

The Impact of Osteoporosis Medications on Muscle Health in Older Adults

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05666310
• Other study ID #: STUDY22080139
• Secondary ID: P30AG024827
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: February 14, 2023
• Est. completion date: July 1, 2026

Study information

• Verified date: February 2024
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: July 1, 2026
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoporosis
• Sarcopenia

Intervention

Drug:
• Denosumab
Half of study participants will randomly receive denosumab 60 mg subcutaneous injection at month 0 and 6 with zoledronic acid placebo at month 0.
• Zoledronic Acid
Half of study participants will randomly receive zoledronic acid 5 mg intravenous infusion at month 0 with denosumab placebo at month 0 and 6. All forty participants will receive zoledronic acid 5 mg intravenous infusion at month 12.

Other:
• Denosumab Placebo
Half of study participants who will randomly receive zoledronic acid 5 mg intravenous infusion at month 0 will also receive denosumab placebo at month 0 and 6.
• Zoledronic Acid Placebo
Half of study participants who will randomly receive denosumab 60 mg subcutaneous injection at month 0 and 6 will also receive zoledronic acid placebo.

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Nami Safai Haeri	National Institute on Aging (NIA), The Claude D. Pepper Older Americans Independence Centers

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage change from baseline in muscle mass (kg) measured by D3-Creatine	D3-Creatine dilution method is a novel method to measure muscle mass	Baseline vs Month 12
Primary	Percentage change from baseline in appendicular lean mass (ALM/body mass index)	Appendicular lean mass is measured by whole body DXA scan and is an index of skeletal muscle mass	Baseline vs Month 12
Primary	Percentage change from baseline in trabecular bone score (TBS)	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	Baseline vs Month 12
Primary	Percentage change from baseline in bone mineral density (BMD) (g/cm²)	BMD is measured by a DXA scan system and a higher BMD is correlated with lower fracture risk	Baseline vs Month 12
Primary	Percentage change from baseline in grip strength (kgf)	Grip strength is measure of muscle strength and will be measured by a standard hand dynamometer	Baseline vs Month 12
Primary	Percentage change from baseline in gait speed (m/s)	Gait speed is a measure of muscle function and will be measured by standard 4 meter gait speed test	Baseline vs Month 12
Primary	Percentage change from baseline in rectus femoris muscle thickness (cm)	This variable will be measured by ultrasound	Baseline vs Month 12
Primary	Percentage change from baseline in rectus femoris muscle cross-sectional surface area (cm²)	This variable will be measured by ultrasound	Baseline vs Month 12