A phase IV, prospective, open label, single-arm, multicenter clinical study to evaluate the safety and efficacy of teriparatide 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 and number of adverse reactions
研究概览
简要总结
This is a phase IV, prospective, open label, single-arm, multicentre clinical study to evaluate the safety and efficacy of teriparatide in patients with postmenopausal osteoporosis.
A total 200 subject who meet eligibility criteria will be given teriparatide (Enzene Biosciences Ltd) 20 mcg 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) 20 mcg 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 the safety of teriparatide injection in patients with postmenopausal osteoporosis.
Secondary Objectives:
To evaluate the efficacy of teriparatide injection in patients with postmenopausal osteoporosis.
To assess the pharmacodynamics (PD) response of teriparatide injection 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 of post menopause, aged > 50 to 80 years
- •Postmenopausal women with osteoporosis.
排除标准
- •known hypersensitivity to teriparatide or any of its excipients
- •pre-existing hypercalcemia
- •severe renal impairment
- •metabolic bone diseases other than postmenopausal osteoporosis.
- •unexplained elevation of alkaline phosphatase
- •Prior external beam or implant radiation therapy to the skeleton.
- •patients with skeletal malignancies or bone metastases should be excluded from the treatment with teriparatide.
- •Any significant medical condition in the opinion of the investigator that does not allow the participation of the patient in the study.
结局指标
主要结局
Number of AEs and number of adverse reactions
时间窗: 26 weeks
次要结局
- 1. Number of serious adverse reaction and serious adverse drug reactions during the study period.(2. percentage change from baseline to week 24 in bone mineral density at lumbar spine and femoral neck)