CTRI/2023/05/052831进行中（未招募）4 期
A phase IV, open label, single-arm, multi-centre clinical study to evaluate the safety and efficacy of denosumab in patients with postmenopausal osteoporosis.
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •1. Women with at least 5 years post menopause, aged > 50 to 80 years.
- •2. Have low bone mass density test (dual energy X-ray absorptiometry) Bone mineral Density Tscore < -2.5 standard deviation at any one of two sites measured ( Lumbar spine [L1-L4] and Femoral neck)
- •3. Women giving written, voluntary informed consent for study participation.
排除标准
- •1. Known hypersensitivity to denosumab or any of its excipients
- •2. Pre-existing hypocalcemia
- •3. Subject previously treated with Denosumab
- •4. Vitamin D deficiency as indicated by serum levels of 25-OH vitamin D test, vitamin D < 20 ng/mL at screening
- •5. Subjects with hyperparathyroidism or hypoparathyroidism at screening
- •6. Subjects with thyroid dysfunction
- •7. Metabolic bone diseases other than postmenopausal osteoporosis including hyperthyroidism, Cushing diseases and Pagets diseases.
- •8. Any of the following oral/dental conditions:
- •a. prior history or current evidence of osteomyelitis or osteonecrosis of jaw
- •b. Active dental or jaw condition which requires oral surgery
- •c. Planned invasive dental procedure
- •d. Non-healed dental or oral surgery
- •9. Any significant medical condition in the opinion of the investigator that does not allow the participation of the patient in the study
- •10. Subjects who are unwilling or unable to comply with the requirements of the protocol
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