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

ConditionOsteoporosis in Post-menopausal Women
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age55-85
SponsorMarmara University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Postmenopausal Women

Patients with Osteoporosis

Patients aged between 55 and 85 years old

Disqualifiers

Patient with history of Serebrovascular diseases

Patient with history of Miyocardial Infarction

Patients who have calcium metabiolism disturbances

Patients with chronic kidney diseases

Trial design

Design model

Factorial

Treatments tested in this trial

  • Romosozumab and Denosumab Combination Therapy

    Drug

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

  • Romosozumab Prefilled Syringe [Evenity]

    Drug

    Romosozumab 210mg subcutaneously per month

  • Denosumab (Prolia)

    Drug

    Denosumab 60 mg subcutaneously per 6 months

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Romosozumab and denosumab combinationExperimental treatment 1 intervention
Group B: RomosozumabActive comparator 1 intervention
Group C: DenosumabActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

New Fracture

If the patient exposed new fracture along treatment period

Time frame
1 year and 9 months
2

Bone Mineral Density

Bone mineral density before treatment regimen and after treatment done

Time frame
1 year

Secondary outcomes

1

New fracture at long term follow up

If the patient exposed new fracture along long term follow up (Phase 2 of this study) period

Time frame
5 years
2

Beta Crosslaps

Beta Crosslaps value througout treatment regimen per 6 months interval

Time frame
6 months interval

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Marmara University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: