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Muscle Impact of Treating Osteoporosis | Clinical Trials | Clareo Health

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Muscle Impact of Treating Osteoporosis

The Impact of Osteoporosis Medications on Muscle Health in Older Adults

NCT05666310•Nami Safai Haeri

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

Age

65 - No limit years

Sex

FEMALE

Healthy Volunteers

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

Locations (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Key Dates

Start Date

February 14, 2023

Primary Completion Date

January 5, 2026

Completion Date

September 5, 2026

Last Updated

January 12, 2026

Enrollment

ACTUAL participants

Conditions

SarcopeniaOsteoporosis

Interventions

Denosumab

DRUG

Zoledronic Acid

DRUG

Denosumab Placebo

OTHER

Zoledronic Acid Placebo

OTHER

Effect of Essential Aminoacid Supplementation and Exercise on Skeletal Muscle Function in Hemodialysis Patients

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Sarcopenia

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RECRUITINGNA

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Predictive Factors for Functional and Quality of Life Decline in Patients >65 Years With a Gastrointestinal Tract Cancer Diagnosis Taken to Curative Resectable Surgery

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 12, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Muscle Impact of Treating Osteoporosis

Inclusion Criteria

Exclusion Criteria

Effect of Essential Aminoacid Supplementation and Exercise on Skeletal Muscle Function in Hemodialysis Patients

Evaluation of the JUICE HA® as an Anti-sarcopenia

Predictive Factors for Functional and Quality of Life Decline in Patients >65 Years With a Gastrointestinal Tract Cancer Diagnosis Taken to Curative Resectable Surgery

Mechanism of TIPS to Improve Sarcopenia

Sarcopenia Magnetic Resonance Imaging Evaluation (SUSIE)

OsteoPorotic fracTure preventION System (OPTIONS) Research Study