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Romosozumab Use to Build Skeletal Integrity

NCT05058976 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 184

Last updated 2026-02-17

No results posted yet for this study

Summary

The purpose of this study is to find out if one year of romosozumab (Evenity®), a monthly injection given in the arm under the skin, prior to an infusion of zoledronic acid Reclast®, works to treat bone loss and prevent it from worsening in older women (ages 65 and older) who have osteoporosis and reside in long-term care (LTC) facilities.

Conditions

  • Osteoporosis
  • Osteoporosis, Postmenopausal
  • Osteoporosis Fracture

Interventions

DRUG

Romosozumab

Monthly dose: 210 mg subcutaneous injection

DRUG

Placebo

Monthly saline injection

DRUG

Zoledronic acid

5 mg IV infusion at Month 12 Visit

DIETARY_SUPPLEMENT

Calcium and Vitamin D

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
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-15
Primary Completion
2027-03-31
Completion
2027-03-31
FDA Drug
Yes

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 NCT05058976 on ClinicalTrials.gov