CTRI/2018/07/014908已完成3 期
A Prospective, Active-controlled, Randomized, Double blind, Multicenter, Phase III Study to Compare the Safety and Efficacy of Biosimilar Denosumab of Enzene Biosciences Limited versus Innovator Denosumab in the Treatment of Postmenopausal Osteoporosis
Alkem Laboratories Limited0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Women with at least 5 years of post-menopause aged > 50 to 80 years;
- •2. Have low bone mass determined by a bone density test (Dual- energy X-ray Absorptiometry [DXA]), Bone Mineral Density (BMD) T-scores < -2.5 standard deviation (SD) at any one of the two sites measured (lumbar spine [L1 ââ?¬â?? L4] and femoral neck);
- •3. Women giving written, voluntary informed consent for study participation.
排除标准
- •1. Women with vertebral abnormalities at L1 to L4 that may interfere with the vertebral assessment by DXA
- •2. Vitamin D deficiency as indicated by serum levels of 25-OH vitamin D test, vitamin D < 20 ng/mL at screening
- •3. Subjects with hyperparathyroidism or hypoparathyroidism at screening
- •4. Subjects with thyroid dysfunction
- •5. Subjects with hypocalcemia or hypercalcemia 6. Subjects with Rheumatoid arthritis
- •7. Any previous treatment with bisphosphonates in the last 12 months prior to screening
- •8. Previous treatment with any other drug affecting bone metabolism in the last 3 months prior to screening;
- •9. Subjects with abnormal laboratory findings at screening: ïâ??· Total Bilirubin > 1.5 times the Upper Limit of the Normal (ULN) laboratory range; ïâ??· ALT and/or AST > 2.5 x ULN; ïâ??· Unexplained elevation of ALP; ïâ??· Serum Creatinine > ULN
- •10. Subjects with positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV) at screening;
- •11. Subject with any evidence of metabolic bone disease other than osteoporosis, which may interfere with the interpretation of the findings, such as Osteomalacia, Osteogenesis Imperfecta, Pagetââ?¬•s disease, Cushingââ?¬•s disease, Hyperprolactinemia.
- •12. Subject with any malignancy
- •13. Subjects with known hypersensitivity to Denosumab or any of its excipients;
- •14. Any of the following Oral/Dental conditions: ïâ??· Prior history or current evidence of osteomyelitis or osteonecrosis of jaw ïâ??· Active dental or jaw condition which requires oral surgery ïâ??· Planned invasive dental procedure ïâ??· Non-healed dental or oral surgery 15. Malabsorption syndrome or any gastrointestinal disorders that are associated with malabsorption
- •16. Subjects with clinical evidence of active or chronic infective illness
- •17. Patients on immunosuppressive therapy
- •18. Any significant medical illness that is preventing the subject from study participation 19. Subjects who are unwilling or unable to comply with the requirements of the protocol
- •20. Subject who has participated in any other clinical study in last 30 days.
- •21. Subject with Hip replacement surgery
研究者
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