Effect of Pioglitazone Versus Metformin on Bone Health in Postmenopausal Women With Type 2 Diabetes (Pioglitazone)
|ClinicalTrials.gov Identifier: NCT01935804|
Recruitment Status : Completed
First Posted : September 5, 2013
Last Update Posted : June 17, 2014
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders||Drug: Pioglitazone Drug: Metformin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||440 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Phase 1 Study of Pioglitazone Versus Metformin on Bone Health in Postmenopausal Women With Type 2 Diabetes|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||January 2014|
Experimental: Experimental: 1
Pioglitazone given 30mg/once daily for 12 months.
30 mg/daily for 12 months
Other Name: Actos
Active Comparator: Active comparator: 2
Metformin given 850 mg/twice daily for 12 months.
850 mg/daily for 12 months
Other Name: Glucophage
- 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. [ Time Frame: 6-18 months ]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.
- Bone turnover Markers and other Biomarkers [ Time Frame: 6-18 months ]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.
- Exploratory and Safety Outcomes [ Time Frame: 6-18 months ]Other endpoints were changes in inflammatory markers (hs-CRP)
- Exploratory Outcomes: lipid profile [ Time Frame: 6-18 months ]lipid profile (total cholesterol, HDL-c, LDL-c and triglycerides)
- Exploratory outcomes: liver and renal function tests [ Time Frame: 6-18 months ]liver function tests [albumin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP)]; renal function tests (creatinine, urea, uric acid) and parathyroid hormone (PTH).
- Exploratory outcomes: glycemic control [ Time Frame: 6-18 months ]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).
- Exploratory and safety outcomes [ Time Frame: 6-18 months ]Safety endpoints were adverse events (AEs), clinical laboratory assessments, vital signs, and electrocardiograms
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01935804
|Center of Excellence for Osteoporosis Research, King Abdulaziz University|
|Jeddah, Makkah, Saudi Arabia, 21589|
|Principal Investigator:||Mohammed-Salleh M Ardawi, PhD, FRCPath||Center of Excellence for Osteoporosis Research and Faculty of Medicine, King Abdulaziz University|
|Study Director:||Abdulrahim A Rouzi, FRCPC||Center of Excellence for Osteoporosis Research, and Faculty of Medicine, King Abdulaziz University|