Trial Outcomes & Findings for Texture Analysis for Postmenopausal Osteoporosis (NCT NCT00145977)
NCT ID: NCT00145977
Last Updated: 2018-09-11
Results Overview
Percent Change in lumbar spine BMD from Baseline to Month 24
COMPLETED
NA
36 participants
Baseline to Month 24
2018-09-11
Participant Flow
Participant milestones
| Measure |
Alendronate
All subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal. This group will also receive alendronate 70 mg once weekly, according to standard recommendations.
Alendronate: Subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal. This group will also receive alendronate 70 mg once weekly, according to standard recommendations.
|
Control
All subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal.
Control: All subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
17
|
|
Overall Study
COMPLETED
|
17
|
13
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
| Measure |
Alendronate
All subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal. This group will also receive alendronate 70 mg once weekly, according to standard recommendations.
Alendronate: Subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal. This group will also receive alendronate 70 mg once weekly, according to standard recommendations.
|
Control
All subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal.
Control: All subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal.
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
0
|
4
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Texture Analysis for Postmenopausal Osteoporosis
Baseline characteristics by cohort
| Measure |
Alendronate
n=19 Participants
All subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal. This group will also receive alendronate 70 mg once weekly, according to standard recommendations.
Alendronate: Subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal. This group will also receive alendronate 70 mg once weekly, according to standard recommendations.
|
Control
n=17 Participants
All subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal.
Control: All subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.4 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
61.1 years
STANDARD_DEVIATION 7.7 • n=7 Participants
|
64.4 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Month 24Population: Three missing values in Alendronate group and five missing values in control group were not imputed.
Percent Change in lumbar spine BMD from Baseline to Month 24
Outcome measures
| Measure |
Alendronate
n=14 Participants
All subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal. This group will also receive alendronate 70 mg once weekly, according to standard recommendations.
Alendronate: Subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal. This group will also receive alendronate 70 mg once weekly, according to standard recommendations.
|
Control
n=8 Participants
All subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal.
Control: All subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal.
|
|---|---|---|
|
Changes in Lumbar Spine BMD +/- Treatment With Alendronate
|
5.28 Percent Change
Standard Deviation 10.0
|
-1.48 Percent Change
Standard Deviation 4.56
|
SECONDARY outcome
Timeframe: Baseline to Month 24Population: Three missing values in Alendronate group and five missing values in control group were not imputed.
Percent Change in peripheral heel BMD from Baseline to Month 24
Outcome measures
| Measure |
Alendronate
n=14 Participants
All subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal. This group will also receive alendronate 70 mg once weekly, according to standard recommendations.
Alendronate: Subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal. This group will also receive alendronate 70 mg once weekly, according to standard recommendations.
|
Control
n=8 Participants
All subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal.
Control: All subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal.
|
|---|---|---|
|
Changes in Peripheral Heel BMD +/- Treatment With Alendronate
|
1.02 Percent Change
Standard Deviation 3.89
|
-1.99 Percent Change
Standard Deviation 6.73
|
SECONDARY outcome
Timeframe: Baseline to Month 24Population: Three missing values in Alendronate group and five missing values in control group were not imputed.
Percent Change in femoral neck BMD from Baseline to Month 24
Outcome measures
| Measure |
Alendronate
n=14 Participants
All subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal. This group will also receive alendronate 70 mg once weekly, according to standard recommendations.
Alendronate: Subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal. This group will also receive alendronate 70 mg once weekly, according to standard recommendations.
|
Control
n=8 Participants
All subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal.
Control: All subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal.
|
|---|---|---|
|
Changes in Femoral Neck BMD +/- Treatment With Alendronate
|
-4.21 Percent Change
Standard Deviation 10.24
|
0.04 Percent Change
Standard Deviation 5.01
|
SECONDARY outcome
Timeframe: Baseline to Month 24Population: Three missing values in Alendronate group and five missing values in control group were not imputed.
Percent Change in total hip BMD from Baseline to Month 24
Outcome measures
| Measure |
Alendronate
n=14 Participants
All subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal. This group will also receive alendronate 70 mg once weekly, according to standard recommendations.
Alendronate: Subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal. This group will also receive alendronate 70 mg once weekly, according to standard recommendations.
|
Control
n=8 Participants
All subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal.
Control: All subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal.
|
|---|---|---|
|
Changes in Total Hip BMD +/- Treatment With Alendronate
|
-3.68 Percent Change
Standard Deviation 9.30
|
-0.77 Percent Change
Standard Deviation 2.70
|
SECONDARY outcome
Timeframe: Baseline to Month 24Population: Three missing values in Alendronate group and five missing values in control group were not imputed.
Root Mean Square (RMS) is a measure of the variability in the radiographic texture pattern, the relative difference in the contrast between light and dark areas is expressed in a grayscale level. In practical terms, a bone image with a washed-out appearance due to loss of trabecular structure such as that seen in osteoporosis, will have a low value for RMS because there will be relatively little contrast between lighter and darker areas of the image. An image of a bone with strong trabecular structure will have a high RMS value because the contrast between the lighter and darker areas of the image will be greater. To derive a measure of variability in the RMS in the region of interest in the bone image, the power spectrum is divided into 24 angular sectors at 15 degree intervals, and RMS is calculated for each segment. The iRMS (integrated RMS) roughly corresponds to RMS averaged across all 24 angular sectors
Outcome measures
| Measure |
Alendronate
n=14 Participants
All subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal. This group will also receive alendronate 70 mg once weekly, according to standard recommendations.
Alendronate: Subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal. This group will also receive alendronate 70 mg once weekly, according to standard recommendations.
|
Control
n=8 Participants
All subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal.
Control: All subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal.
|
|---|---|---|
|
Changes in Radiographic Texture Analysis (RTA) Integrated Root Mean Square (iRMS) From Baseline to Month 24
|
-3.70 Percent Change
Standard Deviation 18.31
|
-0.53 Percent Change
Standard Deviation 3.51
|
SECONDARY outcome
Timeframe: Baseline to Month 24Population: Three missing values in Alendronate group and five missing values in control group were not imputed.
Root Mean Square (RMS) is a measure of the variability in the radiographic texture pattern, the relative difference in the contrast between light and dark areas is expressed in a grayscale level. In practical terms, a bone image with a washed-out appearance due to loss of trabecular structure such as that seen in osteoporosis, will have a low value for RMS because there will be relatively little contrast between lighter and darker areas of the image. An image of a bone with strong trabecular structure will have a high RMS value because the contrast between the lighter and darker areas of the image will be greater. To derive a measure of variability in the RMS in the region of interest of the bone image, the power spectrum is divided into 24 angular sectors at 15 degree intervals, and RMS is calculated for each segment. We use sdRMS (standard deviation of the RMS across the segments) as a measure of the direction dependence (anisotropy) of the trabeculae in the bone image.
Outcome measures
| Measure |
Alendronate
n=14 Participants
All subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal. This group will also receive alendronate 70 mg once weekly, according to standard recommendations.
Alendronate: Subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal. This group will also receive alendronate 70 mg once weekly, according to standard recommendations.
|
Control
n=8 Participants
All subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal.
Control: All subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal.
|
|---|---|---|
|
Changes in Radiographic Texture Analysis (RTA) Feature Standard Deviation of Root Mean Square (sdRMS) From Baseline to Month 24
|
6.85 Percent Change
Standard Deviation 39.30
|
1.08 Percent Change
Standard Deviation 18.85
|
SECONDARY outcome
Timeframe: Baseline to Month 24Population: Three missing values in Alendronate group and five missing values in control group were not imputed.
To derive a measure of variability and directionality in the first moment of the power spectrum (FMP) in the region of interest of the bone image, the power spectrum is divided into 24 angular sectors at 15 degree intervals, and FMP is calculated for each segment. We use iFMP (integrated FMP) as a measure of overall special frequency of the radiographic pattern. FMP characterizes spatial frequency in the radiographic pattern and the underlying trabecular structure. This corresponds to the coarseness or fineness of the radiographic texture pattern. A high level of FMP indicates thin and closely spaced trabecular structure. Low FMP indicates widely spaced dark areas usually corresponding to a strong, thick trabecular structure.
Outcome measures
| Measure |
Alendronate
n=14 Participants
All subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal. This group will also receive alendronate 70 mg once weekly, according to standard recommendations.
Alendronate: Subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal. This group will also receive alendronate 70 mg once weekly, according to standard recommendations.
|
Control
n=8 Participants
All subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal.
Control: All subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal.
|
|---|---|---|
|
Changes in Radiographic Texture Analysis (RTA) Feature Integrated First Moment of the Power Spectrum (iFMP) From Baseline to Month 24
|
0.09 Percent Change
Standard Deviation 5.10
|
1.04 Percent Change
Standard Deviation 2.54
|
SECONDARY outcome
Timeframe: Baseline to Month 24Population: Three missing values in Alendronate group and five missing values in control group were not imputed.
To derive a measure of variability and directionality in the first moment of the power spectrum (FMP) in the region of interest of the bone image, the power spectrum is divided into 24 angular sectors at 15 degree intervals and FMP is calculated for each segment. We use minFMP (minimum FMP) to represent the lowest value of FMP across the 24 angular sectors corresponding to the special frequency in the most washed-out direction. FMP characterizes spatial frequency in the radiographic pattern and the underlying trabecular structure. This corresponds to the coarseness or fineness of the radiographic texture pattern. A high level of FMP indicates thin and closely spaced trabecular structure. Low FMP indicates widely spaced dark areas usually corresponding to a strong, thick trabecular structure.
Outcome measures
| Measure |
Alendronate
n=14 Participants
All subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal. This group will also receive alendronate 70 mg once weekly, according to standard recommendations.
Alendronate: Subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal. This group will also receive alendronate 70 mg once weekly, according to standard recommendations.
|
Control
n=8 Participants
All subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal.
Control: All subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal.
|
|---|---|---|
|
Changes in Radiographic Texture Analysis (RTA) Minimum First Moment of the Power Spectrum (minFMP) From Baseline to Month 24
|
-3.61 Percent Change
Standard Deviation 11.31
|
-0.18 Percent Change
Standard Deviation 6.89
|
SECONDARY outcome
Timeframe: Baseline to Month 24Population: Three missing values in Alendronate group and five missing values in control group were not imputed.
The Percent Change in Radiographic Texture Analysis (RTA) Minkowski Fractal Dimension (MINK) from Baseline to Month 24 is a description of the similarity of texture of the images at different magnifications. The Minkowski fractal dimension is calculated from the slope of the least -square fitted line relating log volume and log magnification.
Outcome measures
| Measure |
Alendronate
n=14 Participants
All subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal. This group will also receive alendronate 70 mg once weekly, according to standard recommendations.
Alendronate: Subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal. This group will also receive alendronate 70 mg once weekly, according to standard recommendations.
|
Control
n=8 Participants
All subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal.
Control: All subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal.
|
|---|---|---|
|
Changes in Radiographic Texture Analysis (RTA) Minkowski Fractal Dimension (MINK) From Baseline to Month 24
|
-0.06 Percent Change
Standard Deviation 0.48
|
0.12 Percent Change
Standard Deviation 0.42
|
SECONDARY outcome
Timeframe: Baseline to Month 24Population: Three missing values in Alendronate group and five missing values in control group were not imputed.
The Percent Change in Radiographic Texture Analysis (RTA) spectral density coefficient beta (BETA) from Baseline to Month 24 is an analysis of spectral density vs. the spacial frequency on a log-log plot. BETA is the coefficient (slope) of this plot. Higher values of beta correspond to rougher (strong bone) and lower values to smoother, higher-frequency texture pattern (washed out bone).
Outcome measures
| Measure |
Alendronate
n=14 Participants
All subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal. This group will also receive alendronate 70 mg once weekly, according to standard recommendations.
Alendronate: Subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal. This group will also receive alendronate 70 mg once weekly, according to standard recommendations.
|
Control
n=8 Participants
All subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal.
Control: All subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal.
|
|---|---|---|
|
Changes in Radiographic Texture Analysis (RTA) Spectral Density Coefficient Beta (BETA) From Baseline to Month 24
|
3.09 Percent Change
Standard Deviation 21.30
|
6.53 Percent Change
Standard Deviation 11.02
|
Adverse Events
Alendronate
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place