Muscle Impact of Treating Osteoporosis

NCT ID: NCT05666310

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-14
• Study Completion Date: 2026-09-05

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Zoledronic Acid

Group Type: ACTIVE_COMPARATOR

Zoledronic Acid

Intervention Type: 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

Intervention Type: 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.

Denosumab

Group Type: ACTIVE_COMPARATOR

Denosumab

Intervention Type: 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 Placebo

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The Claude D. Pepper Older Americans Independence Centers

OTHER

Sponsor Role: collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Nami Safai Haeri

OTHER

Sponsor Role: lead

Responsible Party

Nami Safai Haeri

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Nami Safai Haeri, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

P30AG024827

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY22080139

Identifier Type: -

Identifier Source: org_study_id