NCT05058976

Romosozumab Use to Build Skeletal Integrity

Innovative Approach to Geriatric Osteoporosis

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 184 (actual)
• Sponsor: Susan L. Greenspan · Academic / Other
• Sex: Female
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Objective: The long-term goal of this study is to improve health, well-being and quality of life in the frail Long-term Care (LTC) population by reducing fractures. The short-term goal is to demonstrate efficacy of the novel dual action Romosozumab (ROMO) to improve Bone Mineral Density (BMD) and skeletal integrity and its safety, a necessary (but not sufficient) precondition 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 safety of the sclerostin inhibitor ROMO among a cohort of 200 underserved, institutionalized, frail women ≥65 years old. Bone measures will be collected in a mobile lab. The monthly subcutaneous therapy negates concerns regarding poor oral absorption or compliance. The use of annual Zoledronic Acid (ZOL) to follow ROMO, will prevent bone loss and insure the entire group will be provided with at least 1 year of therapy. The groups include: 1) ROMO →ZOL vs 2) placebo →ZOL. Aim 1: Evaluate efficacy of bone building ROMO treatment prior to ZOL in improving bone mineral density. H1: Women on ROMO →ZOL will have greater hip and spine BMD increases after 2 years (H1.1-primary) and 1 year (H1.2), and at other locations (H1.3). Aim 2: Examine improvements in 3D trabecular microstructure (TBS), markers of bone turnover and collect preliminary evidence for a fracture reduction trial. The investigators will measure vertebral trabecular bone score (TBS), a 3-D microarchitectural image and parameters of the spine, hip, and lateral spine H2: Women on ROMO →ZOL will have greater increases in TBS measures of spine, hip and lateral spine after one (H2.1) and two (H2.2) years; and improvement in bone turnover markers (CTx and P1NP; H2.3). Aim 3: Determine characteristics associated with responders and non responders. The investigators will use multiple regression analyses and other data mining techniques to identify baseline characteristics of responders and non-responders. H3.1: Poor baseline functional/cognitive status/immobility will be associated with poor bone healthy outcomes. H3.2: Greater early changes in bone turnover markers will be associated with greater skeletal improvements.

Conditions

• Osteoporosis
• Osteoporosis, Postmenopausal
• Osteoporosis Fracture

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2021-09-15
• Primary completion: 2027-03-31
• Completion: 2027-03-31
• First posted: 2021-09-28
• Last updated: 2026-02-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study