MedTrace Logo

Preventing Osteoporosis Using Denosumab

NCT02753283 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 201

Last updated 2024-09-19

Study results available
· View outcomes & findings →

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.

Conditions

  • Osteoporosis, Postmenopausal
  • Osteoporosis
  • Osteoporotic Fractures

Interventions

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)

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Institute on Aging (NIA)

    collaborator NIH

  • Susan L. Greenspan

    lead OTHER

Principal Investigators

  • Susan L Greenspan, MD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2023-08-31
Completion
2023-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02753283 on ClinicalTrials.gov