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

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2010
INTERVENTION: 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: 400 microgm. CONDITION: Postmenopausal osteoporosis PRIMARY OUTCOME: Percentage change in biomarker of bone ; formation, Procollagen type 1 N‐terminal peptide (P1NP) from ; baseline‐‐‐‐‐‐Timepoint: 3 months. SECONDARY OUTCOME: 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 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.
Epistemonikos ID: 4b7dfef5026b16518f5b11ffbf5cc88e05b508e5
First added on: Aug 22, 2024