Effects of Cycle Therapy vs Sequential Therapy With Romosozumab and Denosumab in Postmenopausal Osteoporosis Patients
Recruiting · NCT06938152 · Interventional (participants receive a specific treatment) · Lead sponsor: National Taiwan University Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Romosozumab and Denosumab Cycle TherapyRomosozumab followed by Denosumab
What this trial is about
This study is a prospective, randomized, controlled clinical trial comparing the efficacy of a 24-month cyclic therapy regimen (6 months of Romosozumab followed by 6 months of Denosumab, repeated for two years) versus a traditional sequential treatment regimen (12 months of Romosozumab followed by 12 months of Denosumab). The goal is to determine which approach yields better therapeutic outcomes and to optimize drug strategies for osteoporosis patients.
Who can take part
Age range
50 Years to 90 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 1\. Postmenopausal women aged 50-90 years
- 2\. BMD T-score ≤ -3.0 at any lumbar vertebra
- 3\. Physically and mentally capable of understanding and complying with the study protocol and follow-up
- 4\. Signed informed consent
Exclusion criteria
- 1\. Previous osteoporosis treatment within the past two years, including Romosozumab, Teriparatide, Denosumab, Alendronate, Ibandronate, Zoledronic Acid, Risedronate, Raloxifene, or Bazedoxifene
- 2\. Allergy to Romosozumab or Denosumab
- 3\. Secondary osteoporosis
- 4\. Autoimmune disease
- 5\. Chronic steroid use (e.g., Chronic Obstruction Pulmonary Disease patients)
- 6\. Hypercalcemia or hypocalcemia
- 7\. Metabolic bone diseases
- 8\. Primary or metastatic bone tumors
- 9\. Cancer patients (except for in situ carcinoma and non-melanoma skin cancer, unless fully treated and in remission for five years)
- 10\. Planned dental procedures (e.g., extractions, implants) within the next year
- 11\. History of stent placement, myocardial infarction, stroke, or coronary artery disease
- 12\. Renal disease (Creatinine \> 1.5 mg/dL) or dialysis patients
- 13\. Smoking more than one pack per day (except for those who have quit for over ten years)
Where it is running
1 location listed.
- National Taiwan University Hospital - Taipei, Taiwan