Tests romosozumab added to denosumab in women with osteoporosis and multiple fractures
Tests adding romosozumab to denosumab in postmenopausal women with osteoporosis at high fracture risk.
Key facts
- Who runs it
- Marmara University
- Where
- Istanbul, TürkiyeSee the site
- Trial code
- Registry title
- Efficacy of Romosozumab and Denosumab Combined Treatment in Postmenopausal Osteoporosis Patients with Multiple Fragility Fractures
- Status
- Not yet recruiting
- Phase
- Phase 4
- People taking part
- 60 people, planned
- Started
- 15 Jan 2025
- Expected to end
- 15 Dec 2026
- Type of study
- Interventional, 3 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Romosozumab and Denosumab Combination Therapy
- Romosozumab Prefilled Syringe [Evenity]
- Denosumab (Prolia)
- Record updated
- 27 December 2024
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for postmenopausal women with osteoporosis who have had many fragility fractures and have taken denosumab for at least 2 years.
- Age
- 55 to 85 years
- Sex
- Women only
- Disease stage
- Postmenopausal osteoporosis with a very high risk of fragility fractures.
- Earlier treatment
- At least 2 years of denosumab treatment.
Main reasons for not taking part
- History of cerebrovascular disease
- History of myocardial infarction
- Calcium metabolism disturbances
- Chronic kidney disease
- Past allergic reaction to denosumab or romosozumab
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- Postmenopausal Women
- Patients with Osteoporosis
- Patients aged between 55 and 85 years old
Who cannot take part
- Patient with history of Serebrovascular diseases
- Patient with history of Miyocardial Infarction
- Patients with chronic kidney diseases
- Patient with history of allergic reactions to denosumab or romosozumab
- Patients who have calcium metabiolism disturbances
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 55 and 85 years old?
Where in Türkiye
- Marmara UniversityIstanbul, TürkiyeContact: Canan Şanal, Associate ProffesorNo longer taking part
About the trial
What the trial wants to find out
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:
Read full original descriptionShow less
* 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
The 3 groups in the trial
- Romosozumab and denosumab combinationTreatment being tested
Romosozumab 210 mg subcutaneously per month combined with denosumab 60mg subcutaneously per 6 months
Treatment: Romosozumab and Denosumab Combination Therapy
- RomosozumabExisting treatment, for comparison
Romosozumab 210 mg subcutaneously per month
Treatment: Romosozumab Prefilled Syringe [Evenity]
- DenosumabExisting treatment, for comparison
denosumab 60mg subcutaneously per 6 months
Treatment: Denosumab (Prolia)
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Efficacy of Romosozumab and Denosumab Combined Treatment in Postmenopausal Osteoporosis Patients with Multiple Fragility Fractures
- Plain-language title
- Tests romosozumab added to denosumab in women with osteoporosis and multiple fracturesGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06720350, who can take part
- Record updated
- 27 December 2024