Romosozumab Use to Build Skeletal Integrity

Launched by SUSAN L. GREENSPAN · Sep 17, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a treatment called romosozumab (Evenity®) on improving bone health in older women who have osteoporosis. The goal is to see if taking this monthly injection for one year, followed by another treatment called zoledronic acid (Reclast®), can help prevent further bone loss and reduce the risk of fractures. The trial is specifically focused on women aged 65 and older who live in long-term care facilities, such as nursing homes or assisted living.

To participate, women must have osteoporosis, which is determined by a specific bone density measurement or by having a history of fractures. They should also be able to provide consent, either themselves or through a representative. However, women with certain serious health conditions, recent heart problems, or those already on specific osteoporosis medications might not be eligible. Participants can expect to receive regular injections and infusions as part of the study, and their progress will be monitored throughout the trial. This study is important as it aims to find effective treatments to help manage osteoporosis in older adults, potentially improving their quality of life.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• 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.
• Exclusion Criteria:
• • 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.