Romosozumab for Osteoporosis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if romosozumab, a monthly injection, can improve bone and muscle health in postmenopausal women with osteoporosis undergoing lumbar spine surgery. Researchers seek to assess whether this treatment strengthens bones, reduces complications during and after surgery, and increases muscle mass for better recovery. Participants will receive either romosozumab or alendronate (a weekly pill) to compare their effectiveness in this context. Women diagnosed with osteoporosis and planning spine surgery might be suitable candidates for this trial. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant medical advancements.
Will I have to stop taking my current medications?
The trial requires that you have not used osteoporosis medications in the past 3 years and are not currently using certain other medications like anabolic agents or androgen receptor modulators. If you are on these medications, you may need to stop them to participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have shown that romosozumab holds promise in treating osteoporosis, significantly reducing the risk of new spine fractures. However, some safety concerns exist. One study found a slightly higher rate of heart-related side effects with romosozumab compared to alendronate. Specifically, 2.5% of people taking romosozumab experienced heart issues, compared to 1.9% with alendronate. Despite this, overall research suggests that romosozumab is a safe option for many postmenopausal women with osteoporosis. Its approval for treating this condition indicates a positive safety profile.12345
Why do researchers think this study treatment might be promising for osteoporosis?
Romosozumab is unique because it works by targeting a protein called sclerostin, which plays a role in bone formation. Unlike standard treatments for osteoporosis, like bisphosphonates (such as alendronate), which primarily slow bone loss, romosozumab actively stimulates new bone growth. This dual action of increasing bone formation and decreasing bone resorption offers a promising advantage in rapidly improving bone strength. Researchers are excited about its potential to provide quicker and more robust improvements in bone density compared to existing therapies.
What evidence suggests that this trial's treatments could be effective for osteoporosis?
Research has shown that romosozumab improves bone strength, particularly in the lower back. Studies found that after 12 months, patients experienced a significant increase in bone density, reducing the risk of fractures. In this trial, one group of participants will receive romosozumab along with placebo alendronate. In postmenopausal women with osteoporosis, romosozumab reduced the risk of spine and other fractures compared to their condition before treatment. This suggests that romosozumab could strengthen bones and reduce complications during and after spine surgery. Previous patients experienced major improvements in bone health without serious side effects.23678
Who Is on the Research Team?
Nitin Agarwal, M.D.
Principal Investigator
University of Pittsburgh
Are You a Good Fit for This Trial?
This trial is for postmenopausal women with osteoporosis who are planning to have lumbar spine surgery. They should be willing to receive monthly injections or take weekly pills, and attend five study visits over a year. Details about specific inclusion and exclusion criteria were not provided.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either romosozumab or alendronate. Romosozumab is administered as monthly injections, while alendronate is taken weekly. Surgery is performed 3 months after treatment initiation.
Surgery
Participants undergo lumbar spine surgery 3 months after starting treatment.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments at 3 months and 9 months post-operation.
What Are the Treatments Tested in This Trial?
Interventions
- Romosozumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Nitin Agarwal
Lead Sponsor
Amgen
Industry Sponsor
Robert A. Bradway
Amgen
Chief Executive Officer since 2012
MBA from Harvard Business School
Paul Burton
Amgen
Chief Medical Officer since 2023
MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London
Beckwith Foundation
Collaborator