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Efficacy of Romosozumab and Denosumab Combined Treatment in Postmenopausal Osteoporosis Patients with Multiple Fragility Fractures
Sponsor: Marmara University
Summary
The aim of this clinical trial is to investigate the effectiveness of romosozumab started without stopping denosumab in patients diagnosed with postmenopausal osteoporosis with a very high risk of fragility fractures and who is under at least 2 years of denosumab treatment. The main questions aimed to answer are: * Does it effective to prevent fractures add Romosozumab to ongoing denosumab treatment? * If it is appropiate to quit denosumab for starting 1 year romosozumab treatment? * If there is complications in denosumab and romosozumab combination treatment? Researchers will compare the Romosozumab 210mg subcutaneous(sc) monthly plus denosumab 60mg per 6 months sc treatment to prooceeding denosumab treatment and romosozumab 210mg monthly treatment in patient whom denosumab cessaced. Participians are postmenopousal women with osteoporosis and they are under at least 2 years of treatment with denosumab and they will: * Add 210 mg monthly romosozumab sc injection or switch to 210 mg monthly romosozumab sc injection or proceed 60mg per 6 months denosumab sc injection * Visit the clinic at least once every 3 months and first month of new treatment regimen, blood tests per 3 months and Bone mineral density examination per 6 months * Keep a diary of their symptoms
Key Details
Gender
FEMALE
Age Range
55 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2025-01-15
Completion Date
2026-12-15
Last Updated
2024-12-27
Healthy Volunteers
No
Conditions
Interventions
Romosozumab and Denosumab Combination Therapy
Romosozumab 210mg per month and denosumab 60mg per 6 months will be applied
Romosozumab Prefilled Syringe [Evenity]
Romosozumab 210mg subcutaneously per month
Denosumab (Prolia)
Denosumab 60 mg subcutaneously per 6 months
Locations (1)
Marmara University
Istanbul, Turkey (Türkiye)