A prospective, multi-centric, open-label, randomised, controlled study to evaluate the safety and efficacy of teriparatide (rhPTH 1-34) in postmenopausal osteoporosis.

Cadila Healthcare Limited0 个研究点目标入组 83 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Postmenopausal women diagnosed as osteoporosis with T score between ranges of -2.5 to -4 at any one of the two sites measured (lumbar spine and femoral neck).
•2. Subjects who are in the opinion of the investigator, likely to comply with the protocol and the investigator?s instructions during the study period.
•3. Subjects giving informed consent for participation in the study.

•1. History of hypersensitivity to teriparatide or any other PTH.
•2. History of nephrolithiasis/ urolithiasis in the past 1 year.
•3. Abnormal liver function test (ALT/AST>/= 2.5 times UNL) or kidney function test (serum creatinine >/= 2.0 mg/dl and calculated GFR value).
•4. Abnormal or clinically significant laboratory values of parathyroid hormone (PTH), Serum Calcium (Ca), and Alkaline phosphatase (ALP).
•5. History of hyperuricemia/gout.
•6. History of malignancy/ radiotherapy.
•7. History of diseases causing malabsorption in the last one year.
•8. History of iatrogenic menopause.
•9. History of secondary osteoporosis eg. Pagets disease, renal osteodystrophy, osteomalacia, hypoparathyroidism, hyperparathyroidism, hyperthyroidisim, drug induced (Appendix I) etc.
•10. Subjects having history of any vertebral deformities at L1-L4 interfering with the measurement of BMD with Dual energy X-ray Absorptiometry (DEXA)
•11. Subjects using bone modulating drugs (Appendix II), oral/ parenteral steroids and/or Hormone replacement therapy (HRT) in the last six months.
•12. Subjects requiring other unacceptable concomitant medicines eg. Digitalis, Verapamil, diltiazem, diuretics etc.
•13. Subjects with abnormal ECG findings.
•14. Subjects participated in any clinical trial in the last six months.

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