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NOT YET RECRUITING
NCT06720350
PHASE4

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

Sponsor: Marmara University

View on ClinicalTrials.gov

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

Interventions

DRUG

Romosozumab and Denosumab Combination Therapy

Romosozumab 210mg per month and denosumab 60mg per 6 months will be applied

DRUG

Romosozumab Prefilled Syringe [Evenity]

Romosozumab 210mg subcutaneously per month

DRUG

Denosumab (Prolia)

Denosumab 60 mg subcutaneously per 6 months

Locations (1)

Marmara University

Istanbul, Turkey (Türkiye)