Status:
RECRUITING
Effects of Cycle Therapy vs Sequential Therapy With Romosozumab and Denosumab in Postmenopausal Osteoporosis Patients
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Osteoporosis
Osteoporosis Postmenopausal
Eligibility:
FEMALE
50-90 years
Phase:
PHASE4
Brief Summary
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 ...
Detailed Description
Osteoporosis is common in postmenopausal women and the elderly, and has been recognized by the World Health Organization as the second most prevalent metabolic bone disease worldwide. Most patients sh...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2029
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06938152
Start Date
April 8 2025
End Date
December 31 2029
Last Update
December 19 2025
Active Locations (1)
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1
National Taiwan University Hospital
Taipei, Taiwan