A clinical trial to study the safety and efficacy of teriparatide in postmenopausal osteoporosis

Phase 3

Completed

• Conditions: Health Condition 1: M810- Age-related osteoporosis without current pathological fractureHealth Condition 2: null- Postmenopausal osteoporosis

• Registration Number: CTRI/2009/091/000190
• Lead Sponsor: Cadila Healthcare Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 83

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified