N/A
N=36
Texture Analysis for Postmenopausal Osteoporosis
Osteoporosis · Osteopenia
Bottom Line
View on ClinicalTrials.gov: NCT00145977 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Sep 2018
Primary outcome: Primary: Changes in Lumbar Spine BMD +/- Treatment With Alendronate — 5.28; -1.48 Percent Change
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Alendronate (Drug); Calcium Citrate (Dietary_supplement); Vitamin D (Dietary_supplement)
- Age
- Adult, Older Adult · 59+ yrs
- Sex
- Female
- Sponsor
- University of Chicago
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Lumbar Spine BMD +/- Treatment With Alendronate |
5.28; -1.48 | — |
| SECONDARY Changes in Peripheral Heel BMD +/- Treatment With Alendronate |
1.02; -1.99 | — |
| SECONDARY Changes in Femoral Neck BMD +/- Treatment With Alendronate |
-4.21; 0.04 | — |
| SECONDARY Changes in Total Hip BMD +/- Treatment With Alendronate |
-3.68; -0.77 | — |
| SECONDARY Changes in Radiographic Texture Analysis (RTA) Integrated Root Mean Square (iRMS) From Baseline to Month 24 |
-3.70; -0.53 | — |
| SECONDARY Changes in Radiographic Texture Analysis (RTA) Feature Standard Deviation of Root Mean Square (sdRMS) From Baseline to Month 24 |
6.85; 1.08 | — |
| SECONDARY Changes in Radiographic Texture Analysis (RTA) Feature Integrated First Moment of the Power Spectrum (iFMP) From Baseline to Month 24 |
0.09; 1.04 | — |
| SECONDARY Changes in Radiographic Texture Analysis (RTA) Minimum First Moment of the Power Spectrum (minFMP) From Baseline to Month 24 |
-3.61; -0.18 | — |
| SECONDARY Changes in Radiographic Texture Analysis (RTA) Minkowski Fractal Dimension (MINK) From Baseline to Month 24 |
-0.06; 0.12 | — |
| SECONDARY Changes in Radiographic Texture Analysis (RTA) Spectral Density Coefficient Beta (BETA) From Baseline to Month 24 |
3.09; 6.53 | — |
Summary
The purpose of this study is to determine if a new test for osteoporosis can be useful in monitoring treatment. We are studying a new method for examining the quality of bone by an experimental method of computerized analysis of radiographic images (x-ray pictures) of the heel.
Eligibility Criteria
Inclusion Criteria
- The study will enroll 40 postmenopausal women with a T score < -2 either at the lumbar spine or the femoral neck: 20 who decide to begin anti-resorptive therapy (treated group), and 20 women who decline such therapy (control group). We will attempt to match the patients and the controls for T score (within 0.3) and age (within 5 years).
- All study participants will be:
- at least 3 years past the last menstrual period,
- not on HRT, Raloxifene or calcitonin for at least 6 months.
Exclusion Criteria
- All study participants will not be on bisphosphonates during the previous 12 months.
- Women with secondary causes of osteoporosis will be excluded.
Data sourced from ClinicalTrials.gov (NCT00145977). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.