Anabolic Therapy for Osteoporosis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how two FDA-approved medications, denosumab (also known as Prolia or Xgeva) and romosozumab, can treat osteoporosis, a condition where bones weaken and are more prone to fractures. Participants will receive either romosozumab alone or a combination of romosozumab and denosumab to determine which is more effective in reducing fracture risk. Postmenopausal women at high risk of fractures who haven't recently used certain bone medications might be suitable for this study. As a Phase 4 trial, it involves treatments already FDA-approved and proven effective, aiming to understand how they can benefit more patients.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications before participating. If you are currently using or have recently used medications like bisphosphonates, denosumab, estrogens, SERMs, calcitonin, glucocorticoids, romosozumab, strontium, teriparatide, or abaloparatide, you may need to stop them for a specific period before joining the trial.
What is the safety track record for these treatments?
Research has shown that both romosozumab and denosumab are generally safe for treating osteoporosis, but a few considerations are important.
For romosozumab, studies have found it can significantly reduce fracture risk. However, one study reported that 2.5% of patients experienced heart-related issues after 12 months, compared to 1.9% in another group, indicating a slightly higher risk for those with heart concerns.
Limited research suggests that using romosozumab and denosumab together might slightly improve bone strength. No major safety issues specific to the combination have been reported, but the known risks of each drug should be considered.
Both medications have FDA approval for other uses, indicating a good overall safety record. However, discussing potential risks with a healthcare provider is advisable, especially if there are existing health concerns.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about these treatments for osteoporosis because they offer unique approaches compared to traditional therapies like bisphosphonates or selective estrogen receptor modulators. Romosozumab is a standout because it not only slows bone loss but also actively stimulates new bone formation by inhibiting the protein sclerostin. This dual action sets it apart from many existing treatments that focus solely on preventing bone breakdown. Additionally, the combination of Romosozumab with Denosumab, another treatment involved in the trial, could potentially enhance bone density more effectively by pairing bone-building and anti-resorptive actions, offering a comprehensive approach to managing osteoporosis.
What evidence suggests that this trial's treatments could be effective for osteoporosis?
Research has shown that romosozumab, one of the treatments in this trial, effectively treats osteoporosis. Studies have found that using this treatment for 12 months significantly improves bone strength, particularly in the spine and hip areas. It also reduces the risk of fractures in postmenopausal women, a major concern with osteoporosis.
Another treatment arm in this trial involves combining romosozumab with denosumab. This combination can further enhance bone strength, especially for patients who have not achieved good results with denosumab alone. Both treatments have FDA approval and have shown promise in strengthening bones and reducing fracture risk.45678Who Is on the Research Team?
Benjamin Leder, MD
Principal Investigator
Massachusetts General Hospital
Are You a Good Fit for This Trial?
This trial is for postmenopausal women at high risk of fracture. Participants must not have severe kidney disease, uncontrolled skin conditions, very low or high calcium levels, certain bone diseases other than osteoporosis, recent heart issues, or a history of significant lung disease. They should not have used specific osteoporosis treatments recently and must not be currently abusing substances.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 alone or in combination with Denosumab for osteoporosis treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Denosumab
- Romosozumab
Denosumab is already approved in European Union, United States, Canada, Japan for the following indications:
- Osteoporosis in postmenopausal women
- Bone loss associated with hormone ablation therapy for prostate cancer
- Bone loss associated with hormone ablation therapy for breast cancer
- Treatment of postmenopausal women with osteoporosis at high risk for fracture
- Treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer
- Treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer
- Treatment of osteoporosis in postmenopausal women at high risk for fracture
- Treatment to increase bone mass in men with osteoporosis at high risk for fracture
- Treatment of osteoporosis in postmenopausal women
- Treatment of bone loss associated with hormone ablation therapy for prostate cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor