Preserving Geriatric Muscle With an Osteoporosis Medication

NCT06118905 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: STUDY23020192
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 1

Brief Summary

Our goal is to demonstrate efficacy of the novel agent Denosumab to improve or preserve muscle health, strength, mobility and function in frail older adults.

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (1)

• Knee extension strength change

  The primary muscle strength outcome measure will be the peak muscle force generated by the dominant leg (same side as dominant hand) knee extensor muscles in the sitting position with the knee at 60 degrees of flexion.

  12 Months

Study Arms (2)

Denosumab

EXPERIMENTAL

Denosumab 60mg SQ with placebo zoledronic acid

Drug: Denosumab 60 MG/ML

Zoledronic acid

ACTIVE COMPARATOR

Zoledronic acid 5mg IV with Denosumab placebo

Drug: Zoledronic Acid 5Mg/Bag 100Ml Infusion

Interventions

Denosumab 60 MG/ML DRUG

Subjects to receive Denosumab 60mg SQ and Zoledronic acid placebo IV

Also known as: Prolia

Denosumab

Zoledronic Acid 5Mg/Bag 100Ml Infusion DRUG

Subjects to receive Zoledronic Acid 5mg IV and Denosumab placebo

Also known as: Reclast

Zoledronic acid

Eligibility Criteria

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

You may qualify if:

• Ambulatory male and female residents with osteoporosis or low bone mass (at risk for fracture) age 65 and older will be considered if: 1) they reside in an institution (nursing home, assisted living facility or senior community) and; 2) they have osteoporosis as diagnosed by a) BMD (spine, hip or forearm BMD T-score ≤ -2.5 SD), b) a previous adult fragility spine or hip fracture, or c) have osteopenia but would be treated based on FRAX and the BHOF treatment thresholds of a 10-year major fracture risk of ≥ 20% or ≥ 3% hip fracture risk using femoral neck BMD.

You may not qualify if:

• We will exclude residents with subacute illnesses surviving or those with life expectancy \<1 year. We will exclude those currently on a related therapy (including a bisphosphonate, Denosumab, teriparatide, abaloparatide, or romosozumab) or who have been on a bisphosphonate for \>1 year during the previous 2 years because some bisphosphonates are long acting. We will exclude subjects with a history of hypocalcemia or contraindication for treatment or those who are on systemic glucocorticoids that may lower muscle strength. We will screen for these conditions by detailed history, chart review, and baseline laboratory analyses. Participants with 25-hydroxyvitamin D levels \<25 ng/mL will be treated with vitamin D 50,000 IU/wk for 8 weeks. The patient will be enrolled if the follow-up vitamin D level is 25 ng/mL or more. Patients will be allowed to continue on anticonvulsants because use is common in this population. Women on hormone replacement, raloxifene, or residents prescribed protective hip pads will be allowed to participate and continue on these therapies. We will suggest participants stop calcitonin due to cancer concerns.

Sponsors & Collaborators

• Susan L. Greenspan: lead

Study Sites (1)

St. Barnabas Woodlands

Pittsburgh, Pennsylvania, 16059, United States

RECRUITING

MeSH Terms

Conditions

Osteoporosis

Interventions

Denosumab; Zoledronic Acid

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Susan Greenspan, MD

CONTACT

+14128554806; greenspn@pitt.edu

Nicholas Gatto, BS

CONTACT

4126089525; NJG29@PITT.EDU

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: Professor

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: November 7, 2023
• Study Start: February 8, 2024
• Primary Completion (Estimated): February 28, 2029
• Study Completion (Estimated): March 31, 2029
• Last Updated: February 10, 2026

Record last verified: 2026-02

Locations

US (1)