Romosozumab + Zoledronic Acid for Osteoporosis
(RUBI Trial)
Trial Summary
What is the purpose of this trial?
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.
Do I need to stop my current medications for the trial?
You can continue taking medications that affect bone and mineral metabolism, like glucocorticoids and anticonvulsants, and osteoporosis agents like estrogen/progesterone or raloxifene if prescribed by your doctor. However, you cannot participate if you are currently on certain osteoporosis therapies like bisphosphonates, denosumab, teriparatide, abaloparatide, or romosozumab.
What data supports the effectiveness of the drug Romosozumab for osteoporosis?
Research shows that Romosozumab is effective in treating osteoporosis by increasing bone density and reducing the risk of fractures, especially in postmenopausal women. Studies have demonstrated that it works well when used alone or followed by another drug called denosumab, leading to ongoing improvements in bone health.12345
Is Romosozumab safe for humans?
Romosozumab has been studied for safety in several clinical trials for osteoporosis, and while it is generally considered safe, there may be potential cardiovascular risks (related to the heart and blood vessels) associated with its use. The FDA's adverse event reporting system is used to monitor any unexpected side effects.26789
How does the drug romosozumab differ from other osteoporosis treatments?
Romosozumab is unique because it is a monoclonal antibody that both promotes bone formation and reduces bone breakdown by targeting sclerostin, a protein that regulates bone growth. This dual action leads to rapid and significant increases in bone density, which is more effective than many other treatments like bisphosphonates or parathyroid hormone analogs. It is typically followed by another drug to maintain its benefits.410111213
Research Team
Susan L Greenspan, MD
Principal Investigator
University of Pittsburgh
Eligibility Criteria
This trial is for women aged 65 or older with osteoporosis, living in long-term care facilities. They must have a bone density score of -2.5 SD or lower, a history of fractures, or meet certain risk criteria. Excluded are non-walkers, those with recent severe heart issues, kidney problems preventing IV treatment, recent stroke or heart attack victims, current users of specific osteoporosis meds and very low vitamin D levels.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive monthly subcutaneous injections of Romosozumab for 12 months, followed by a Zoledronic Acid infusion
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Romosozumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Susan L. Greenspan
Lead Sponsor
National Institutes of Health (NIH)
Collaborator
National Institute on Aging (NIA)
Collaborator