JPRN-jRCTs071180087已完成4 期
Comparative effect of daily teriparatide, weekly teriparatide, or bisphosphonate on bone microarchitecture in patients with primary osteoporosis: A HR-pQCT study. - TERABIT study
Osaki Makoto0 个研究点目标入组 131 人开始时间: 2019年3月29日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 131
研究概览
简要总结
We investigated the differences in the effects of daily teriparatide (20 micro g), weekly high-dose teriparatide (56.5 micro g), and bisphosphonate on postmenopausal osteoporosis patients with fragile fractures. D-PTH, W-PTH, and BPs were all shown to improve bone structure, although they exhibited different mechanisms and degrees of effects.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 60age old 至 <= 89age old(—)
- 性别
- Female
入选标准
- •1.Age: Patients over 60 years old and less than 89 years old.
- •2.Gender: female.
- •3.Inpatient or Outpatient: unmentioned.
- •4.Primary osteoporosis patients with one or more previous fragility fractures (e.g., proximal femoral fracture, vertebral fracture, distal radius fracture, proximal humerus fracture, rib fracture, pelvic fracture, lower leg fracture).
- •5.Medical history using Vitamin D preparation: unmentioned.
- •6.After receiving sufficient explanation for participation in this study, patients who gained written consent by the patient's free will with sufficient understanding.
排除标准
- •1.Patients with serious cardiac disorder, serious liver dysfunction, serious kidney dysfunction, diabetes mellitus, endocrine and metabolic diseases which may affect to the bone metabolism, and secondary osteoporosis (e.g., glucocorticoid-induced osteoporosis, rheumatoid arthritis, immobilization osteoporosis).
- •2.Patients treated with medication which affect to the bone metabolism as follows,
- •i)Glucocorticosteroids (within 6 months before enrollment, or >5mg for over 3 months) except inhaler or nasal drip.
- •ii)Anti-cancer drugs.
- •iii)Anti-osteoporosis drugs (teriparatide, anti-RANKL antibody, bisphosphonates within 6 months before enrollment, SERMs within 3 months before enrollment, or estrogen preparations).
- •3.Patients who have contraindication of teriparatide or bisphosphonate.
- •4.Patients who have severe allergy.
- •5.Patients enrolled in other clinical studies in the past 3 months.
- •6.Patients judged to be inadequate for this study by investigators.
研究者
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