Efficacy of Romosozumab and Denosumab Combined Treatment in Postmenopausal Osteoporosis Patients with Multiple Fragility Fractures

• Status: NOT_YET_RECRUITING
• Trial end date: 2026-12-15

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

• Phase: PHASE4

Details

• Lead Sponsor: Marmara University
• Treatments: Denosumab; romosozumab