Effects of Cycle Therapy vs Sequential Therapy With Romosozumab and Denosumab in Postmenopausal Osteoporosis Patients
Effects of Cycle Therapy With Romosozumab and Denosumab 2 Years vs 1 Year Romosozumab Followed by 1 Year Denosumab in Postmenopausal Osteoporosis Patients-A Randomized Control Trial
National Taiwan University Hospital
70 participants
Apr 8, 2025
INTERVENTIONAL
Conditions
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 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.
Eligibility
Inclusion Criteria4
- \. Postmenopausal women aged 50-90 years
- \. BMD T-score ≤ -3.0 at any lumbar vertebra
- \. Physically and mentally capable of understanding and complying with the study protocol and follow-up
- \. Signed informed consent
Exclusion Criteria13
- \. Previous osteoporosis treatment within the past two years, including Romosozumab, Teriparatide, Denosumab, Alendronate, Ibandronate, Zoledronic Acid, Risedronate, Raloxifene, or Bazedoxifene
- \. Allergy to Romosozumab or Denosumab
- \. Secondary osteoporosis
- \. Autoimmune disease
- \. Chronic steroid use (e.g., Chronic Obstruction Pulmonary Disease patients)
- \. Hypercalcemia or hypocalcemia
- \. Metabolic bone diseases
- \. Primary or metastatic bone tumors
- \. Cancer patients (except for in situ carcinoma and non-melanoma skin cancer, unless fully treated and in remission for five years)
- \. Planned dental procedures (e.g., extractions, implants) within the next year
- \. History of stent placement, myocardial infarction, stroke, or coronary artery disease
- \. Renal disease (Creatinine > 1.5 mg/dL) or dialysis patients
- \. Smoking more than one pack per day (except for those who have quit for over ten years)
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Interventions
Romosozumab 210mg/month for 12 months, then Denosumab 60mg/6months for 12 months
Romosozumab 210mg/month for 6 months then followed by Denosumab 60mg/6months once, and then repeat one more time after 6 months
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06938152