| Outcome Measures: |
Primary: Adjusted Percent Change From Baseline in Femoral Neck (FN) Bone Mineral Density (BMD) Via Dual-energy X-ray Absorptiometry (DXA) at Week 52, FN BMD (measured in grams per centimeters squared \[g/cm\^2\]) was measured by DXA. Bone mineral density is calculated as the mineral content of a bone divided by the area of the bone. DXA is the principal technique used for measuring BMD. Percent change from Baseline at Week 52 was calculated as (BMD at Week 52 minus BMD at Baseline)/BMD at Baseline x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Change in FN BMD at Week 52 was only analyzed within the Rosiglitazone arm., Baseline and Week 52|Adjusted Percent Change From Baseline in Femoral Neck (FN) Bone Mineral Density (BMD) Via Dual-energy X-ray Absorptiometry (DXA) at Week 76+10 Days, FN BMD (measured in grams per centimeters squared \[g/cm\^2\]) was measured by DXA. Bone mineral density is calculated as the mineral content of a bone divided by the area of the bone. DXA is the principal technique used for measuring BMD. Percent change from Baseline at Week 76+10 days was calculated as (BMD at Week 76+10 days minus BMD at Baseline)/BMD at Baseline x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region., Baseline and Week 76+10 days|Adjusted Percent Change in Femoral Neck (FN) Bone Mineral Density (BMD) Via Dual-energy X-ray Absorptiometry (DXA) From Week 52 +10 Days to Week 76+10 Days, FN BMD (measured in grams per centimeters squared \[g/cm\^2\]) was measured by DXA. Bone mineral density is calculated as the mineral content of a bone divided by the area of the bone. DXA is the principal technique used for measuring BMD. Percent change from Week 52+10 days to Week 76+10 days was calculated as (BMD at Week 76+10 days minus BMD at Week 52+10 days)/BMD at Week 52+10 days x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region., Week 52+10 days and Week 76+10 days | Secondary: Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA at Week 52, BMD (measured in grams per centimeters squared \[g/cm\^2\]) was measured by DXA. Percent change from Baseline at Week 52 was calculated as (BMD at Week 52 minus BMD at Baseline)/BMD at Baseline x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region., Baseline and Week 52|Adjusted Percent Change in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA From Week 52+10 Days to Week 76 + 10 Days, BMD (measured in grams per centimeters squared \[g/cm\^2\]) was measured by DXA. Percent change from Week 52 + 10 days toat Week 76 + 10 days was calculated as (BMD at Week 76 + 10 days minus BMD at Week 52 + 10 days)/BMD at Week 52 + 10 days x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region., Week 52 + 10 days and Week 76 + 10 days|Adjusted Percent Change in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA From Week 52+30 Days to Week 76 + 30 Days, BMD (measured in grams per centimeters squared \[g/cm\^2\]) was measured by DXA. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (BMD at Week 76 + 30 days minus BMD at Week 52 + 30 days)/BMD at Week 52 + 30 days x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region., Week 52 + 30 days and Week 76 + 30 days|Adjusted Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) and Procollagen Type 1 N-propeptide (P1NP) at Week 52 and Week 76, BSAP and P1NP levels were measured in micrograms per liter (mcg/L) from blood samples. BSAP and P1NP are indicators of bone buildup or formation. GM, geometric mean; SE, standard error. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region., Baseline, Week 52, and Week 76|Adjusted Percent Change in Bone Specific Alkaline Phosphatase (BSAP) and Procollagen Type 1 N-propeptide (P1NP) From Week 52 to Week 76, BSAP and P1NP levels were measured in micrograms per liter (mcg/L) from blood samples. BSAP and P1NP are indicators of bone buildup or formation. GM, geometric mean; SE, standard error. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region., Week 52 and Week 76|Adjusted Percent Change From Baseline in Carboxyterminal Cross-linked Telopeptide of Type 1 Collagen (CTX) at Week 52 and Week 76, CTX levels were measured in picograms per milliliter (pg/ml) from blood samples. CTX is an indicator of bone break down or resorption. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region., Baseline, Week 52, and Week 76|Adjusted Percent Change in Carboxyterminal Cross-linked Telopeptide of Type 1 Collagen (CTX) From Week 52 to Week 76, CTX levels were measured in picograms per milliliter (pg/ml) from blood samples. CTX is an indicator of bone break down or resorption. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region., Week 52 and Week 76|Adjusted Percent Change From Baseline in 25-Hydroxyvitamin D (Vitamin D) at Week 52 and Week 76, Vitamin D levels were measured in nanomoles per Liter (nmol/L) from blood samples. Vitamin D is required for good bone health. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region., Baseline, Week 52, and Week 76|Adjusted Percent Change in 25-Hydroxyvitamin D (Vitamin D) From Week 52 to Week 76, Vitamin D levels were measured in nanomoles per Liter (nmol/L) from blood samples. Vitamin D is required for good bone health. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region., Week 52 and Week 76|Adjusted Percent Change From Baseline in Intact Parathyroid Hormone (PTH) at Week 52 and Week 76, Intact PTH levels were measured in nanograms per Liter (ng/L) from blood samples. Intact PTH is the amount of PTH circulating in the blood and influences bone health. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region., Baseline, Week 52, and Week 76|Adjusted Percent Change in Intact Parathyroid Hormone (PTH) From Week 52 to Week 76, Intact PTH levels were measured in nanograms per Liter (ng/L) from blood samples. Intact PTH is the amount of PTH circulating in the blood and influences bone health. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region., Week 52 and Week 76|Percent Change From Baseline in Serum Estradiol at Week 52 and Week 76, Serum estradiol levels were measured in picomoles per Liter (pmol/L) from blood samples. Estradiol is one form of the female sex hormone estrogen and influences bone health. Percent change from baseline was based on log-transformed data., Baseline, Week 52, and Week 76|Percent Change in Serum Estradiol From Week 52 to Week 76, Serum estradiol levels were measured in picomoles per Liter (pmol/L) from blood samples. Estradiol is one form of the female sex hormone estrogen and influences bone health. Percent change from baseline was based on log-transformed data., Week 52 and Week 76|Percent Change From Baseline in Total Testosterone at Week 52 and Week 76, Total testosterone levels were measured in nanomoles per Liter (nmol/L) from blood samples. Testosterone is a male sex hormone and influences bone health; total testosterone is the entire amount circulating in blood. Percent change from baseline was based on log-transformed data., Baseline, Week 52, and Week 76|Percent Change in Total Testosterone From Week 52 to Week 76, Total testosterone levels were measured in nanomoles per Liter (nmol/L) from blood samples. Testosterone is a male sex hormone and influences bone health; total testosterone is the entire amount circulating in blood. Percent change from baseline was based on log-transformed data., Week 52 and Week 76|Percent Change From Baseline in Free Testosterone at Week 52 and Week 76, Free testosterone levels were measured as a percentage of total testosterone from blood samples. Free testosterone is the amount of testosterone available to the body for use. Percent change from baseline was based on log-transformed data., Baseline, Week 52, and Week 76|Percent Change in Free Testosterone From Week 52 to Week 76, Free testosterone levels were measured as a percentage of total testosterone from blood samples. Free testosterone is the amount of testosterone available to the body for use. Percent change from baseline was based on log-transformed data., Week 52 and Week 76|Percent Change From Baseline in Sex Hormone Binding Globulin (SHBG) at Week 52 and Week 76, SHBG levels were measured in nanomoles per liter (nmol/L) from blood samples. SHBG binds to estradiol and testosterone and influences the amount of estradiol or testosterone available to the body for use. Percent change from baseline was based on log-transformed data., Baseline, Week 52, and Week 76|Percent Change in Sex Hormone Binding Globulin (SHBG) From Week 52 to Week 76, SHBG levels were measured in nanomoles per liter (nmol/L) from blood samples. SHBG binds to estradiol and testosterone and influences the amount of estradiol or testosterone available to the body for use. Percent change from baseline was based on log-transformed data., Week 52 and Week 76 | Other: Percent Change in Percentage of Free Estradiol From Week 52 to Week 76, Free estradiol levels were measured as a percentage of serum estrogen from blood samples. Free estradiol is the amount of estrogen available to the body for use. Percent change was based on log-transformed data., Week 52 and Week 76|Percent Change in Free Estradiol From Week 52 to Week 76, Free estradiol levels were measured in picomoles per Liter (pmol/L) from blood samples. Free estrodial is the amount of estrogen available to the body for use. Change was based on log-transformed data., Week 52 and Week 76
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| Locations: |
GSK Investigational Site, Tucson, Arizona, 85745, United States|GSK Investigational Site, Huntington Park, California, 90255, United States|GSK Investigational Site, Los Angeles, California, 90022, United States|GSK Investigational Site, Sacramento, California, 95823, United States|GSK Investigational Site, San Diego, California, 92117, United States|GSK Investigational Site, Torrance, California, 90502, United States|GSK Investigational Site, Vista, California, 92081, United States|GSK Investigational Site, Miami, Florida, 33143, United States|GSK Investigational Site, Miami, Florida, 33156, United States|GSK Investigational Site, Lexington, Kentucky, 40504, United States|GSK Investigational Site, Slidell, Louisiana, 70461, United States|GSK Investigational Site, Las Vegas, Nevada, 89117, United States|GSK Investigational Site, Albuquerque, New Mexico, 87102, United States|GSK Investigational Site, Albuquerque, New Mexico, 87106, United States|GSK Investigational Site, East Syracuse, New York, 13057, United States|GSK Investigational Site, Kingston, New York, 12401, United States|GSK Investigational Site, Columbia, South Carolina, 29201, United States|GSK Investigational Site, Columbia, South Carolina, 29204, United States|GSK Investigational Site, Kingsport, Tennessee, 37660, United States|GSK Investigational Site, San Antonio, Texas, 78221, United States|GSK Investigational Site, Wenatchee, Washington, 98801, United States|GSK Investigational Site, Ciudad Autonoma de Buenos Aires, Buenos Aires, B1704ETD, Argentina|GSK Investigational Site, Ciudad Autonoma de Buenos Aires, Buenos Aires, C1012AAR, Argentina|GSK Investigational Site, Buenos Aires, 1425, Argentina|GSK Investigational Site, Ciudad Autónoma de Buenos Aires, C1128AAF, Argentina|GSK Investigational Site, Vancouver, British Columbia, V6H 3X8, Canada|GSK Investigational Site, Brampton, Ontario, L6T 3T1, Canada|GSK Investigational Site, Granby, Quebec, J2G 8Z9, Canada|GSK Investigational Site, Tallinn, 13415, Estonia|GSK Investigational Site, Tallin, 13419, Estonia|GSK Investigational Site, Cuernavaca, Morelos, 62250, Mexico|GSK Investigational Site, Monterrey, Nuevo León, 64460, Mexico|GSK Investigational Site, Mérida, Yucatán, 97129, Mexico|GSK Investigational Site, Durango, 34000, Mexico|GSK Investigational Site, Lahore, 54000, Pakistan|GSK Investigational Site, Manila, 01008, Philippines|GSK Investigational Site, Marikina City, 1810, Philippines|GSK Investigational Site, Alicante, 03114, Spain|GSK Investigational Site, Benidorm/Alicante, 03503, Spain|GSK Investigational Site, Granada, 18003, Spain|GSK Investigational Site, Granada, 18014, Spain|GSK Investigational Site, Petrer, 03610, Spain
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