200 Participants Needed

Romosozumab + Zoledronic Acid for Osteoporosis

(RUBI Trial)

CP
AB
BM
Overseen ByBari M Guzikowski, BA
Prior Safety DataThis treatment has passed at least one previous human 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

SL

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

Willing and able to complete the informed consent process or provide consent by proxy
I am a woman aged 65 or older living in a care facility.
I have osteoporosis or had a major bone fracture.

Exclusion Criteria

Your vitamin D levels are lower than 25 ng/mL.
I am currently taking or have recently taken medication for osteoporosis.
I am unable to walk on my own.
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive monthly subcutaneous injections of Romosozumab for 12 months, followed by a Zoledronic Acid infusion

12 months
12 visits (in-person) for injections, 1 visit (in-person) for infusion

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months
Regular monitoring visits

Treatment Details

Interventions

  • Romosozumab
Trial OverviewThe study tests if romosozumab injections followed by zoledronic acid infusion can improve bone health in elderly women with osteoporosis at LTC facilities. It compares the effects to placebo treatments alongside standard calcium and vitamin D supplements.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Romosozumab, then Zoledronic AcidExperimental Treatment3 Interventions
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.
Group II: Placebo, then Zoledronic AcidPlacebo Group3 Interventions
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Susan L. Greenspan

Lead Sponsor

Trials
6
Recruited
990+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

National Institute on Aging (NIA)

Collaborator

Trials
1,841
Recruited
28,150,000+

Findings from Research

In a study of 148 postmenopausal osteoporosis patients, those who were treatment-naïve showed the greatest increase in bone mineral density (BMD) after 12 months of romosozumab treatment, with an 18.2% increase in lumbar spine BMD compared to lower increases in patients previously treated with bisphosphonates or other therapies.
The effectiveness of romosozumab in increasing BMD was significantly influenced by the type of prior treatment and early changes in bone turnover markers, indicating that these factors can help predict treatment response.
Effects of prior osteoporosis treatment on 12-month treatment response of romosozumab in patients with postmenopausal osteoporosis.Ebina, K., Tsuboi, H., Nagayama, Y., et al.[2021]
Romosozumab significantly reduces the incidence of new vertebral fractures in postmenopausal women with osteoporosis after just 12 months of treatment, showing strong efficacy compared to both placebo and active bisphosphonate controls.
However, there is a concerning numerical increase in cardiovascular events associated with romosozumab, suggesting it should be used cautiously, especially in patients with a history of cardiovascular issues or high cardiovascular risk.
Romosozumab: a Review of Efficacy, Safety, and Cardiovascular Risk.Fixen, C., Tunoa, J.[2021]
Romosozumab treatment significantly increased bone mineral density (BMD) in the lumbar spine compared to denosumab, with increases of 4.9% and 5.2% at 3 and 6 months, respectively, versus 2.3% and 3.2% for denosumab.
Despite the improvement in BMD, romosozumab did not significantly affect disease activity in rheumatoid arthritis (RA) patients over the 6-month study period, indicating that while it may help with bone health, it does not impact RA symptoms.
Effects of romosozumab or denosumab treatment on the bone mineral density and disease activity for 6 months in patients with rheumatoid arthritis with severe osteoporosis: An open-label, randomized, pilot study.Mochizuki, T., Yano, K., Ikari, K., et al.[2022]

References

Effects of prior osteoporosis treatment on 12-month treatment response of romosozumab in patients with postmenopausal osteoporosis. [2021]
Romosozumab: a Review of Efficacy, Safety, and Cardiovascular Risk. [2021]
Effects of romosozumab or denosumab treatment on the bone mineral density and disease activity for 6 months in patients with rheumatoid arthritis with severe osteoporosis: An open-label, randomized, pilot study. [2022]
[The sequential therapy of romosozumab followed by denosumab for osteoporosis.] [2019]
Effects of prior osteoporosis treatment on early treatment response of romosozumab in patients with postmenopausal osteoporosis. [2021]
A pharmacovigilance analysis of FDA adverse event reporting system events for romosozumab. [2023]
Romosozumab: A Novel Injectable Sclerostin Inhibitor With Anabolic and Antiresorptive Effects for Osteoporosis. [2021]
Romosozumab versus Teriparatide for the Treatment of Postmenopausal Osteoporosis: A Systematic Review and Meta-analysis through a Grade Analysis of Evidence. [2023]
Romosozumab treatment in postmenopausal women with osteoporosis: a meta-analysis of randomized controlled trials. [2019]
Romosozumab: A Review in Postmenopausal Osteoporosis. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
Effect of Romosozumab Treatment in Postmenopausal Women With Osteoporosis and Knee Osteoarthritis: Results From a Substudy of a Phase 3 Clinical Trial. [2023]
Effects of romosozumab with and without active vitamin D analog supplementation for postmenopausal osteoporosis. [2022]
Clinical Utility of Romosozumab in the Management of Osteoporosis: Focus on Patient Selection and Perspectives. [2022]