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Clinical Trials in Turkey / NCT06720350
Starting soon Phase 4

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

NCT06720350 · tracked via the Priya Life Science Turkey tracker
Sponsor
Marmara University
Phase
Phase 4
Started
2025-01-15
Last updated
2024-12-27

Condition(s) studied

Osteoporosis in Post-menopausal Women

Investigational drug(s) / intervention(s)

Romosozumab and Denosumab Combination TherapyRomosozumab Prefilled Syringe [Evenity] →Denosumab (Prolia) →

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

Study 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

Eligibility

Sex
FEMALE
Min age
55 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria: * Postmenopausal Women * Patients with Osteoporosis * Patients aged between 55 and 85 years old Exclusion Criteria: * Patient with history of Serebrovascular diseases * Patient with history of Miyocardial Infarction * Patients who have calcium metabiolism disturbances * Patients with chronic kidney diseases * Patient with history of allergic reactions to denosumab or romosozumab

Primary outcome measure(s)

  • New Fracture — 1 year and 9 months
    If the patient exposed new fracture along treatment period
  • Bone Mineral Density — 1 year
    Bone mineral density before treatment regimen and after treatment done

Trial sites (1)

FacilityCityRegionStatus
Marmara University Istanbul Turkey (Türkiye)

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06720350 on ClinicalTrials.gov ↗ ← All trials in Turkey