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临床试验/JPRN-jRCTs071180087
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

发起方
Osaki Makoto

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