Health Condition 1: M810- Age-related osteoporosis without current pathological fracture Health Condition 2: null- Postmenopausal osteoporosis
Conditions
Interventions
Intervention1: Teriparatide: 20 microgram OD Subcutaneous for 12 weeks
Control Intervention1: Calcium + Vitamin D3: Calcium 1000 mg + Vitamin D3 400mcg PO once daily
Control Intervention2: Vitamin D:
Sponsors
Cadila Healthcare Limited
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change in biomarker of bone formation, Procollagen type 1 N-terminal peptide (P1NP) from baselineTimepoint: 3 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage change in: 1. Biomarker of bone formation, Bone specific alkaline phosphatase (BSAP) from baseline. 2. Bone Mineral density (BMD) at the end of 3 months over baseline, at lumbar spine (L1-L4).Timepoint: At the end of 3 months | — |
Countries
India
Contacts
Public ContactDr Rajendra H Jani
Cadila Healthcare Limited
Outcome results
None listed