CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 201 enrolled
Drug / intervention
denosumab +2 moredrug
Likely dose
denosumab 60 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02753283
NCT02753283Phase 4Completed
CompareCT.gov

Sustaining Skeletal Health in Frail Elderly

Susan L. Greenspan·interventional·Posted Apr 27, 2016·Updated Sep 19, 2024

In Brief

A Phase 4 clinical trial evaluating denosumab, Placebo, and 1 other intervention for Osteoporosis, Postmenopausal and 2 related conditions. Completed, enrolled 201 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoporosis, Postmenopausal, Osteoporosis, Osteoporotic Fractures
CountriesUnited States
CollaboratorsNational Institutes of Health (NIH), National Institute on Aging (NIA)

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedApr 27, 2016
Enrollment StartJun 1, 2016
Primary CompletionAug 1, 2023
TodayJul 2, 2026
Enrollment to primary: 7.2 yearsPosted 10.2 years ago

Interventions

denosumabdrug

Semi-annual dose: 60 mg injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)

Placebodrug

Semi-annual saline injection

Calcium and Vitamin Ddietary

Dietary supplement: Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)