Effects of Cycle Therapy vs Sequential Therapy With Romosozumab and Denosumab in Postmenopausal Osteoporosis Patients
Trial Parameters
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 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 Criteria
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 placeme