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OpenTrials
Active, Not Recruiting

NCT Number: NCT05666310

Muscle Impact of Treating Osteoporosis

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Sarcopenia Atrophy Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Muscular Atrophy Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Nutritional and Metabolic Diseases Osteoporosis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

65 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

  • Osteoporosis by axial bone density (spine, hip or forearm BMD T-score ≤-2.5 SD) or
  • A previous adult fragility fracture of the spine or hip or
  • 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

  • Patients with a calculated creatinine clearance < 35 ml/min or
  • Who have a contraindication for bisphosphonates or denosumab or
  • Those who are scheduled for a tooth extraction to avoid jaw osteonecrosis or
  • Subjects with severe liver disease or
  • 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
  • Men

Treatment and study plan

Denosumab

Drug

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

Drug

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.

Denosumab Placebo

Other

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

Other

Half of study participants who will randomly receive denosumab 60 mg subcutaneous injection at month 0 and 6 will also receive zoledronic acid placebo.

Primary outcomes

  1. Percentage change from baseline in muscle mass (kg) measured by D3-Creatine

    Time frame: Baseline vs Month 12

    D3-Creatine dilution method is a novel method to measure muscle mass

  2. Percentage change from baseline in appendicular lean mass (ALM/body mass index)

    Time frame: Baseline vs Month 12

    Appendicular lean mass is measured by whole body DXA scan and is an index of skeletal muscle mass

  3. Percentage change from baseline in trabecular bone score (TBS)

    Time frame: 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

  4. Percentage change from baseline in bone mineral density (BMD) (g/cm²)

    Time frame: Baseline vs Month 12

    BMD is measured by a DXA scan system and a higher BMD is correlated with lower fracture risk

  5. Percentage change from baseline in grip strength (kgf)

    Time frame: Baseline vs Month 12

    Grip strength is measure of muscle strength and will be measured by a standard hand dynamometer

  6. Percentage change from baseline in gait speed (m/s)

    Time frame: Baseline vs Month 12

    Gait speed is a measure of muscle function and will be measured by standard 4 meter gait speed test

  7. Percentage change from baseline in rectus femoris muscle thickness (cm)

    Time frame: Baseline vs Month 12

    This variable will be measured by ultrasound

  8. Percentage change from baseline in rectus femoris muscle cross-sectional surface area (cm²)

    Time frame: Baseline vs Month 12

    This variable will be measured by ultrasound

Sponsors and collaborators

Lead sponsor

Nami Safai Haeri

Other

Collaborators

  • National Institute on Aging (NIA)
  • The Claude D. Pepper Older Americans Independence Centers

Registry information

Official study title

The Impact of Osteoporosis Medications on Muscle Health in Older Adults

Acronym: MITO

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 27, 2022
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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