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ACTIVE NOT RECRUITING
NCT05666310
PHASE4

Muscle Impact of Treating Osteoporosis

Sponsor: Nami Safai Haeri

View on ClinicalTrials.gov

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.

Official title: The Impact of Osteoporosis Medications on Muscle Health in Older Adults

Key Details

Gender

FEMALE

Age Range

65 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2023-02-14

Completion Date

2026-09-05

Last Updated

2026-01-12

Healthy Volunteers

No

Interventions

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.

DRUG

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.

OTHER

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 (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, United States