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

Phase 3

Completed

Conditions: Age-related osteoporosis without current pathological fracture, Postmenopausal osteoporosis,

Brief Summary: This study is a prospective, multi-centric, open-label, randomised, controlled study to evaluate the safety and efficacy of teriparatide (rhPTH1-34) in postmenopausal women with osteoporosis.Primary Objective of this study is to assess the percentage change in biomarker of bone formation, Procollagen type 1 N-terminal peptide (P1NP) from baseline at 3 months in postmenopausal osteoporosis.Secondary Objective(s) of this study are to assess the percentage change in biomarker of bone formation, Bone specific alkaline phosphatase (BSAP) from baseline at the end of 3 months and Bone Mineral density (BMD) at the end of 3 months over baseline, at lumbar spine (L1-L4).

Recruitment & Eligibility

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).
Subjects who are in the opinion of the investigator, likely to comply with the protocol and the investigator?s instructions during the study period.
Subjects giving informed consent for participation in the study.

Exclusion Criteria

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.

Primary Outcome Measures

Name	Time	Method
Percentage change in biomarker of bone	3 months.
formation, Procollagen type 1 N-terminal peptide (P1NP) from	3 months.
baseline	3 months.

Secondary Outcome Measures

Name	Time	Method
Percentage change in:	1. Biomarker of bone formation, Bone specific alkaline phosphatase (BSAP) from baseline.

Locations (8): Ashwini Accident and Multi Specialty Hospital
🇮🇳
Nashik, MAHARASHTRA, India
HCG Medisurge Hospital
🇮🇳
Ahmadabad, GUJARAT, India
Institute of Postgraduate Medical Education & Research (IPGMER)
🇮🇳
Kolkata, WEST BENGAL, India
KEM Hospital
🇮🇳
Pune, MAHARASHTRA, India
Oyster and Pearl Hospitals Pvt. Ltd
🇮🇳
Pune, MAHARASHTRA, India
Parakh Hospital
🇮🇳
Mumbai, MAHARASHTRA, India
Post-Graduate Institute of Medical Education & Research (PGIMER)
🇮🇳
Chandigarh, CHANDIGARH, India
Sterling Hospital
🇮🇳
Ahmadabad, GUJARAT, India
Ashwini Accident and Multi Specialty Hospital
🇮🇳Nashik, MAHARASHTRA, India
Dr Girsh Autade
Principal investigator
09822060200
autudegj@gmail.com