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）
- 入组人数
- 200
- 试验地点
- 6
- 主要终点
- Number of AEs (adverse events) and Number of adverse reactions (ARs)
研究概览
简要总结
A phase IV, open label, single-arm, multi-centre clinical study to evaluate the safety and efficacy of denosumab in patients with postmenopausal osteoporosis.
A total 200 subject who meet eligibility criteria will be given Denosumab (Enzene Biosciences Ltd) 60 mg subcutaneously once only.
The study duration will be approximately 53 weeks considering 24 weeks of recruitment period and 29 weeks of study period.
The study comprises of 3 periods:
Screening Period: It will last up to 3 weeks
Treatment Period: It will last for 24 weeks; all subjects will receive Denosumab (Enzene Biosciences Ltd) 60 mg subcutaneously once only;
Follow-up Period: It will last for 2 weeks after completion of Treatment Period.
Primary Objectives:
The primary objective of this study is to evaluate safety of denosumab in patients with postmenopausal osteoporosis.
Secondary Objectives:
To evaluate efficacy of denosumab in patients with postmenopausal osteoporosis
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 50.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women with at least 5 years post menopause, aged > 50 to 80 years.
- •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)
- •Women giving written, voluntary informed consent for study participation.
排除标准
- •Known hypersensitivity to denosumab or any of its excipients
- •Pre-existing hypocalcemia
- •Subject previously treated with Denosumab
- •Vitamin D deficiency as indicated by serum levels of 25-OH vitamin D test, vitamin D < 20 ng/mL at screening
- •Subjects with hyperparathyroidism or hypoparathyroidism at screening
- •Subjects with thyroid dysfunction
- •Metabolic bone diseases other than postmenopausal osteoporosis including hyperthyroidism, Cushing diseases and Pagets diseases.
- •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.
- •Non-healed dental or oral surgery
- •Any significant medical condition in the opinion of the investigator that does not allow the participation of the patient in the study
- •Subjects who are unwilling or unable to comply with the requirements of the protocol.
结局指标
主要结局
Number of AEs (adverse events) and Number of adverse reactions (ARs)
时间窗: Baseline, week 12, week 24 and week 26
次要结局
- 1. Number of serious adverse events (SAEs) and serious adverse drug reactions (SADRs) during the study period.(2. Percentage change from baseline to Week 24 in bone mineral density (BMD) at lumbar spine and femoral neck.)