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临床试验/IRCT138810121414N5
IRCT138810121414N5已完成3 期

Comparing the effects of recombinant form of human PTH and the Brand type (Forteo) in improving Bone Mineral Density in patients having osteoporosis

Cinagen biotechnology0 个研究点目标入组 92 人开始时间: 待定最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
92

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
45 years 至 75 years(—)
性别
Female

入选标准

  • Inclusion Criteria:
  • Patients are menopause women aged 45-75 who have following conditions: A) T-score less than -3 in lumbar vertebras, neck of femur or total hip in bone mass densitometry by DEXA method without evidences of fracture with low trauma due to osteoporosis. B) T-score less than -2.5 in one of mentioned regions due to osteoporosis with low trauma in vertebras or limbs. C) Women aged 55 and over with T-score less than -2.5 in one of regions of lumbar vertebras, neck of femur or total hip in bone mass densitometry by DEXA method without evidence of fracture with low trauma due to osteoporosis. D) Women aged 55 and over with T-score less than -2 at one of mentioned regions with history of fracture due to osteoporosis and low trauma in vertebras or limbs.
  • Exclusion criteria:
  • A) Rejecting to take part in the study and anticipating lack of cooperation during treatment and follow up periods. B) History of taking bone resorption inhibitor medications such as; Bisphosphanates at least for four weeks. C) Having a disease or being under treatment that interacts with bone metabolism and disrupts treatment process like auto-immune diseases, long term taking of Corticosteroid, chemotherapy or radiotherapy, epilepsy under treatment. D) Hypercalcemia above 10 mg/dl or hypercalceuria with ratio of Uca/Ucr>0.35, history of receiving PTH or stransium, history of urinary stones, advanced stage of liver or kidney disorders, intestinal malabsorbtion, hyper& hypoparathyroidism, hyperthyroidism, history of cancer in 5 years before the first visit, hyperuricemia and gout, lactation.

排除标准

  • 未提供

研究者

发起方
Cinagen biotechnology

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