Muscle Impact of Treating Osteoporosis

NCT05666310 | Active Not Recruiting Phase 4 FDA Drug

• 2 other identifiers: STUDY22080139P30AG024827
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia; Osteoporosis

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• 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

• 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

• 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

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

  This variable will be measured by ultrasound

  Baseline vs Month 12

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

  This variable will be measured by ultrasound

  Baseline vs Month 12

Study Arms (2)

Zoledronic Acid

ACTIVE COMPARATOR

Drug: Zoledronic Acid; Other: Denosumab Placebo

Denosumab

ACTIVE COMPARATOR

Drug: Denosumab; Other: Zoledronic Acid Placebo

Interventions

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.

Denosumab

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.

Zoledronic Acid

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

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.

Denosumab

Eligibility Criteria

• Age: 65 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nami Safai Haeri: lead
• The Claude D. Pepper Older Americans Independence Centers: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Sarcopenia; Osteoporosis

Interventions

Denosumab; Zoledronic Acid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Nami Safai Haeri, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 15, 2022
• First Posted: December 27, 2022
• Study Start: February 14, 2023
• Primary Completion: January 5, 2026
• Study Completion (Estimated): September 5, 2026
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)