| Outcome Measures: |
Primary: Change in mean percentage change in BMD at various sites by Dual energy X-ray absorptiometry(DXA) from baseline and at 6, 12 months in PIO versus MET treatment group., The primary endpoint was change in mean percentage change in BMD values at the lumbar spine (L1-L4), femoral neck and total hip by DXA from baseline and at 6 and 12 months in the PIO and the MET treatment groups., 6-18 months | Secondary: Bone turnover Markers and other Biomarkers, Secondary end-points were changes in serum sclerostin, serum bone-specific alkaline phosphatase (BSAP), serum procollagen type1 N-terminal propeptide (P1NP) and serum C-terminal crosslinking telopeptide of type 1 collagen (CTX); and urinary N-terminal crosslinking telopeptide type 1 collagen (u-NTX); serum calcium, 25-hydroxyvitamin D (25-OHD), and serum Dickkopf-1( DKK-1) at various time intervals from baseline between PIO vs MET treatment., 6-18 months | Other: Exploratory and Safety Outcomes, Other endpoints were changes in inflammatory markers (hs-CRP), 6-18 months|Exploratory Outcomes: lipid profile, lipid profile (total cholesterol, HDL-c, LDL-c and triglycerides), 6-18 months|Exploratory outcomes: liver and renal function tests, liver function tests \[albumin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP)\]; renal function tests (creatinine, urea, uric acid) and parathyroid hormone (PTH)., 6-18 months|Exploratory outcomes: glycemic control, within and between treatment group comparisons of change from baseline at specified time points in HbA1c, fasting plasma glucose (FPG), fasting plasma insulin, and insulin sensitivity measured by the homeostasis model assessment (HOMA-s)., 6-18 months|Exploratory and safety outcomes, Safety endpoints were adverse events (AEs), clinical laboratory assessments, vital signs, and electrocardiograms, 6-18 months
|
