JPRN-jRCTs031180235已完成4 期
Fracture inhibitory effect verification test of osteoporosis drug for primary osteoporosis patients at high risk of fracture-Clinical trial of sequential therapy of once-weekly teriparatide and alendronate or monotherapy of alendronate-JOINT-05 - Fracture inhibitory effect verification test of osteoporosis drug for primary osteoporosis patients at high risk of fracture
Mori Satoshi0 个研究点目标入组 1,011 人开始时间: 2019年3月12日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,011
研究概览
简要总结
In the analysis of the primary endpoint , the incidence of morphometric vertebral fracture in the teriparatide groupwas significantly lower than that in the alendronate group with the rate ratio of 0.78(95% CI 0.61 to 0.99, p = 0.04). The incidence of non-vertebral fractures in the teriparatide group was 1.09 (95% CI 0.68 to 1.75) compared to the alendronate group. The 95% CI cap did not exceed the preset margin of 1.96 (p <0.01 for non-inferiority).
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 75age old 至 ot applicable（—）
- 性别
- Female
入选标准
- •A document agreement of the clinical study participation is provided and intends for a patient meeting all the following standards
- •1.Primary osteoporosis
- •2.a Japanese patient 75 years or older
- •3.postmenopausal women
- •4.The patient that an independence walk is possible
- •5.The patient who satisfies any of the following:
- •Patient with less than in bone density 60% of YAM or less than -3.3SD,
- •The patient who has vertebral body bone fractures more than two to the fourth lumbar vertebrae from the fourth thoracic vertebra at the time of registration,
- •Patient having a bone fracture of grade 3,
- •The patient who has the past of the proximal thighbone bone fracture
排除标准
- •1.Secondary osteoporosis
- •2.bone loss Disease other than osteoporosis
- •3.diseases that affect the strength of the vertebral body
- •4.hypersensitivity
- •5.use of contraindicated therapeutic drugs
- •6.severe complications such as heart disease, liver disease, renal disease
- •7.problem with the reliability of the interview data
- •8.inpatient
- •9.Patients treated with teriparatide in the past
研究者
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