Using romosozumab to improve bone health in older women with osteoporosis
Innovative Approach to Geriatric Osteoporosis
This study is testing if a monthly injection of romosozumab can help improve bone health and prevent fractures in older women with osteoporosis living in long-term care facilities.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 65 Years and up |
| Sex | Female |
| Sponsor | University of Pittsburgh Academic / other |
| Drugs / interventions | denosumab, romosozumab |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT05058976 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of romosozumab, a monthly injection, in improving bone mineral density and preventing fractures in older women aged 65 and above who reside in long-term care facilities and have osteoporosis. Participants will receive either romosozumab followed by zoledronic acid or a placebo followed by zoledronic acid over a two-year period. The study will assess changes in bone density and microstructure, as well as safety outcomes. The approach includes a randomized, double-blind design to ensure unbiased results.
Who should consider this trial
Good fit: Ideal candidates are women aged 65 and older living in nursing homes or assisted living facilities with a diagnosis of osteoporosis.
Not a fit: Patients with recent acute cardiovascular or cerebrovascular events or those not expected to survive for at least two years may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the risk of fractures and improve the quality of life for elderly women with osteoporosis.
How similar studies have performed: Previous studies have shown promise with similar treatments for osteoporosis, but this specific combination approach is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Pittsburgh, Pennsylvania
- UPMC Senior Communities — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Susan L Greenspan, MD — University of Pittsburgh
- Study coordinator: Cristie Porco, RN
- Email: clp98@pitt.edu
- Phone: 412-692-2483
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.