Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
18-month Change From Baseline in Total Hip Trabecular Volumetric Bone Mineral Density Assessed by Computed Tomography (CT) in mg/cm^3 |
To determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet on the 18-month change from baseline in total hip trabecular volumetric bone mineral density (vBMD). Total hip trabecular vBMD (in mg/cm^3) was measured from the baseline and 18-month quantitative CT scans using the Mindways Model 3 phantom to calibrate the vBMD measures. The 18-month change in total hip trabecular vBMD from baseline is reported for this outcome measure. |
Change from Baseline to Month 18 |
|
Secondary |
6-month Change From Baseline in Percentage of Adipose Tissue Within the Lumbar Spine Bone Marrow as Assessed by Dual-energy Computed Tomography Algorithm |
Percentage of adipose tissue within the lumbar spine bone marrow as assessed by a dual-energy computed tomography (CT) algorithm to determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet. Percentage of adipose tissue within the bone marrow was measured from the baseline and 6-month dual-energy CT scans using a Mindways Model 3 phantom for calibration. The 6-month change in percentage of adipose tissue within the lumbar spine bone marrow from baseline is reported for this outcome measure. |
Change from Baseline to Month 6 |
|
Secondary |
18-month Change From Baseline in Percentage of Adipose Tissue Within the Lumbar Spine Bone Marrow as Assessed by Dual-energy Computed Tomography Algorithm |
Percentage of adipose tissue within the lumbar spine bone marrow as assessed by a dual-energy computed tomography (CT) algorithm to determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet. Percentage of adipose tissue within the bone marrow was measured from the baseline and 18-month dual-energy CT scans using a Mindways Model 3 phantom for calibration. The 18-month change in percentage of adipose tissue within the lumbar spine bone marrow from baseline is reported for this outcome measure. |
Change from Baseline to Month 18 |
|
Secondary |
6-month Change From Baseline in Femoral Bone Strength in kN |
Subject-specific finite element models were created from the baseline and 6-month CT scans and femoral bone strength was assessed from a simulated test of a sideways fall. Bone strength was measured as the peak section force extracted at the femoral neck to determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet on the 6-month change from baseline in femoral bone strength. |
Change from Baseline to Month 6 |
|
Secondary |
18-month Change From Baseline in Femoral Bone Strength in kN |
Subject-specific finite element models were created from the baseline and 18-month CT scans and femoral bone strength was assessed from a simulated test of a sideways fall. Bone strength was measured as the peak section force extracted at the femoral neck to determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet on the 18-month change from baseline in femoral bone strength. |
Change from Baseline to Month 18 |
|
Secondary |
18-month Change From Baseline in Femoral Cortical Thickness Assessed by Computed Tomography (CT) in mm |
Cortical thickness of the proximal femur was assessed by a computed tomography (CT) based algorithm to determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet on the 18-month change from baseline in femoral cortical thickness. Cortical thickness was measured from the baseline and 18-month CT scans, and the 18-month change from baseline (in mm) is reported for this outcome measure. |
Change from Baseline to Month 18 |
|
Secondary |
6-month Change From Baseline in Femoral Cortical Thickness Assessed by Computed Tomography (CT) in mm |
Cortical thickness of the proximal femur was assessed by a computed tomography (CT) based algorithm to determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet on the 6-month change from baseline in femoral cortical thickness. Cortical thickness was measured from the baseline and 6-month CT scans, and the 6-month change from baseline (in mm) is reported for this outcome measure. |
Change from Baseline to Month 6 |
|
Secondary |
18-month Change From Baseline in Vertebral Volumetric Bone Mineral Density in the Lumbar Spine Assessed by Computed Tomography (CT) in mg/cm^3 |
To determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet on the 18-month change from baseline in vertebral volumetric bone mineral density (vBMD) in the lumbar spine. Trabecular vBMD (in mg/cm^3) was measured from the baseline and 18-month quantitative CT scans using the Mindways Model 3 phantom to calibrate the vertebral vBMD measures. The 18-month change in vertebral vBMD in the lumbar spine from baseline is reported for this outcome measure. |
Change from Baseline to Month 18 |
|
Secondary |
6-month Change From Baseline in Vertebral Volumetric Bone Mineral Density in the Lumbar Spine Assessed by Computed Tomography (CT) in mg/cm^3 |
To determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet on the 6-month change from baseline in vertebral volumetric bone mineral density (vBMD) in the lumbar spine. Trabecular vBMD (in mg/cm^3) was measured from the baseline and 6-month quantitative CT scans using the Mindways Model 3 phantom to calibrate the vertebral vBMD measures. The 6-month change in vertebral vBMD in the lumbar spine from baseline is reported for this outcome measure. |
Change from Baseline to Month 6 |
|
Secondary |
6-month Change From Baseline in Total Hip Trabecular Volumetric Bone Mineral Density Assessed by Computed Tomography (CT) in mg/cm^3 |
To determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet on the 6-month change from baseline in total hip trabecular volumetric bone mineral density (vBMD). Total hip trabecular vBMD (in mg/cm^3) was measured from the baseline and 6-month quantitative CT scans using the Mindways Model 3 phantom to calibrate the vBMD measures. The 6-month change in total hip trabecular vBMD from baseline is reported for this outcome measure. |
Change from Baseline to Month 6 |
|