NCT02753283

Preventing Osteoporosis Using Denosumab

Sustaining Skeletal Health in Frail Elderly

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 201 (actual)
• Sponsor: Susan L. Greenspan · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to find out if denosumab (Prolia®), an injection given in the arm under the skin every 6 months, works to treat bone loss and prevent it from worsening in older men and women (ages 65 and older) who have osteoporosis and reside in long-term care (LTC) facilities.

Detailed description

Objective: The long term goal is to improve health, well-being and quality of life in the frail long-term care (LTC) elderly population by reducing fractures. The short term goal is to demonstrate efficacy of the non-bisphosphonate denosumab to improve bone mineral density (BMD), a necessary (but not sufficient) pre-condition of a large fracture reduction trial. The investigators propose to conduct a 2-year, randomized, double-blind, calcium-vitamin D controlled trial to test the efficacy and predictability of the antiresorptive RANK ligand inhibitor, denosumab (60 mg), among a cohort of 212 institutionalized, under-served, frail men and women ≥65 years old in LTC. Specific Aims: Aim 1: To evaluate efficacy of denosumab in improving/maintaining bone mineral density. The investigators will measure conventional hip and spine bone mineral density (BMD). Primary Hypothesis: After 2 years, women and men on denosumab will have greater hip and spine BMD increases.

Conditions

• Osteoporosis, Postmenopausal
• Osteoporosis
• Osteoporotic Fractures

Interventions

Type	Name	Description
DRUG	denosumab	Semi-annual dose: 60 mg injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
DRUG	Placebo	Semi-annual saline injection
DIETARY_SUPPLEMENT	Calcium and Vitamin D	Dietary supplement: Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)

Timeline

• Start date: 2016-06-01
• Primary completion: 2023-08-01
• Completion: 2023-08-01
• First posted: 2016-04-27
• Last updated: 2024-09-19
• Results posted: 2024-09-19

Locations

1 site across 1 country: United States