Romosozumab Use to Build Skeletal Integrity

NCT05058976 | Active Not Recruiting Phase 4 DMC FDA Drug

• 2 other identifiers: STUDY200600285R01AG066825-02
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Bone loss; Nursing Home Patients; Long-term Care Patients; Osteoporotic Fractures

Outcome Measures

Primary Outcomes (2)

• Bone Mineral Density of the total hip

  Bone Mineral Density (BMD) of the total hip at 24 months as assessed by dual-energy x-ray absorptiometry (DXA)

  24 months

• Bone Mineral Density of the spine

  Bone Mineral Density (BMD) of the spine at 24 months as assessed by dual-energy x-ray absorptiometry (DXA)

  24 months

Study Arms (2)

Romosozumab, then Zoledronic Acid

EXPERIMENTAL

Monthly dose: 210 mg Romosozumab subcutaneous injections; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplements); all participants will receive 5 mg Zoledronic Acid IV infusion at the Month 12 visit.

Drug: Romosozumab; Drug: Zoledronic acid; Dietary Supplement: Calcium and Vitamin D

Placebo, then Zoledronic Acid

PLACEBO COMPARATOR

Monthly dose: placebo saline subcutaneous injections; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplements); all participants will receive 5 mg Zoledronic Acid IV infusion at the Month 12 visit.

Drug: Placebo; Drug: Zoledronic acid; Dietary Supplement: Calcium and Vitamin D

Interventions

Romosozumab DRUG

Monthly dose: 210 mg subcutaneous injection

Also known as: Evenity

Romosozumab, then Zoledronic Acid

Placebo DRUG

Monthly saline injection

Placebo, then Zoledronic Acid

Zoledronic acid DRUG

5 mg IV infusion at Month 12 Visit

Also known as: Reclast

Placebo, then Zoledronic Acid; Romosozumab, then Zoledronic Acid

Calcium and Vitamin D DIETARY_SUPPLEMENT

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

Placebo, then Zoledronic Acid; Romosozumab, then Zoledronic Acid

Eligibility Criteria

• Age: 65 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Elderly women 65 years and older will be considered if:
• They reside in an institution (nursing home or assisted living facility or senior care community);
• They have a) osteoporosis by axial bone density (spine, hip or forearm BMD T-score≤ -2.5 SD), b) a previous adult fragility fracture of the spine or hip or c) would be treated based on FRAX and the National Osteoporosis Foundation (NOF) treatment thresholds of a 10 year risk of 10% for a major osteoporotic fracture or ≥ 3% for hip fracture using femoral neck BMD.
• Willing and able to complete the informed consent process or provide consent by proxy.

You may not qualify if:

• Those with subacute illnesses who are not expected to survive or who will be discharged in less than 2 years.
• Those who have previously had an acute cardiovascular or cerebrovascular event within the preceding year. specifically, no recent history of coronary heart disease, heart failure, significant arrhythmia, stroke or Transient Ischemic Attack (TIA).
• Recent cardiovascular disease (CVD) symptoms (significant chest pain, congestive heart failure, shortness of breath, or palpitations or cerebrovascular symptoms such as numbness or weakness in the face, arm, legs, difficulty talking, changes in vision, loss of balance, headache, feeling light-headed or dizzy).
• Unstable angina.
• Those who are currently on therapy (including a bisphosphonate, denosumab, teriparatide, abaloparatide or romosozumab) or have been on a bisphosphonate for greater than 1 year during the previous 2 years.
• Those who are unable to take an intravenous bisphosphonate (zoledronic acid) due to renal insufficiency with eGFR \< 35 ml/min.
• Vitamin D levels \<25 ng/mL.
• Participants will be allowed to continue on medications known to affect bone and mineral metabolism (e.g., glucocorticoids, anticonvulsants) because their use is common in this population.
• Those who have been treated in the past or present with osteoporosis agents, such as estrogen/progesterone or raloxifene will be allowed to participate and continue on these therapies if prescribed by their physician.
• Patients will be allowed to wear hip pads if prescribed by their physician.
• Non-ambulatory residents (those who cannot stand and pivot with assistance in order to transfer to the DXA table) will be excluded.

Sponsors & Collaborators

• Susan L. Greenspan: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

UPMC Senior Communities

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Osteoporosis; Osteoporosis, Postmenopausal; Osteoporotic Fractures; Bone Diseases, Metabolic

Interventions

romosozumab; Zoledronic Acid; Calcium; Vitamin D

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Fractures, Bone; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Susan L Greenspan, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: September 17, 2021
• First Posted: September 28, 2021
• Study Start: September 15, 2021
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Any data request will be considered only after main planned manuscripts have been accepted for publication.
• Access Criteria: The PI and the investigative team will review data requests. If approved, all essential identifying information will be removed prior to data distribution. When a request of the data is received, a data sharing agreement will be sent to the requestor which will specifically include requirements for privacy and confidentiality, especially that no attempt will be made to identify study participants, that the data will not be redistributed, and will be destroyed after completing the specific stated purpose. Upon receipt of the signed data sharing agreement, the PI will send the distribution file to the requestor using an appropriate modality such as email or cloud storage.

Locations

US (1)