Recruiting

Osteoporosis Medication

Sponsor:

Susan L. Greenspan

Code:

NCT06118905

Conditions

Osteoporosis

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Denosumab 60 MG/ML

Zoledronic Acid 5Mg/Bag 100Ml Infusion

Study Details

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

Study ID

NCT06118905

Start date

Feb 8, 2024

Status verified date

Feb, 2026

Completion date

Mar 31, 2029

Anticipated

Primary completion date

Feb 28, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Design

Enrollment

155 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Denosumab

Denosumab 60mg SQ with placebo zoledronic acid

active comparator: Zoledronic acid

Zoledronic acid 5mg IV with Denosumab placebo

Interventions

Denosumab 60 MG/ML

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

Zoledronic Acid 5Mg/Bag 100Ml Infusion

Subjects to receive Zoledronic Acid 5mg IV and Denosumab placebo

Primary outcome measure

  • Knee extension strength change [ Time Frame: 12 Months ]

Central Contacts and Locations

Central contacts

Nicholas Gatto, BS

4126089525NJG29@PITT.EDU

Locations

St. Barnabas Woodlands

Recruiting

Pittsburgh, Pennsylvania, United States, 16059

More Information

Sponsor

Susan L. Greenspan

Last update posted

Feb 10, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Susan L. Greenspan on 2026-02-10.