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Texture Analysis for Postmenopausal Osteoporosis

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ClinicalTrials.gov Identifier: NCT00145977
Recruitment Status : Completed
First Posted : September 5, 2005
Results First Posted : September 11, 2018
Last Update Posted : September 11, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
University of Chicago

Brief 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.

Condition or disease Intervention/treatment Phase
Osteoporosis Osteopenia Drug: Alendronate Dietary Supplement: Calcium Citrate Dietary Supplement: Vitamin D Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Changes in Bone Density, Radiographic Texture Analysis and Bone Turnover During Two Years of Antiresorptive Therapy for Postmenopausal Osteoporosis
Study Start Date : July 2001
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

Arm Intervention/treatment
Experimental: Experimental
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.
Drug: Alendronate
alendronate 70 mg once weekly
Other Name: fosamax

Dietary Supplement: Calcium Citrate
600 mg of calcium citrate

Dietary Supplement: Vitamin D
500 mg of Vitamin D consumed with the evening meal.

Active Comparator: Control
All subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal.
Dietary Supplement: Calcium Citrate
600 mg of calcium citrate

Dietary Supplement: Vitamin D
500 mg of Vitamin D consumed with the evening meal.




Primary Outcome Measures :
  1. Changes in Lumbar Spine BMD +/- Treatment With Alendronate [ Time Frame: Baseline to Month 24 ]
    Percent Change in lumbar spine BMD from Baseline to Month 24


Secondary Outcome Measures :
  1. Changes in Peripheral Heel BMD +/- Treatment With Alendronate [ Time Frame: Baseline to Month 24 ]
    Percent Change in peripheral heel BMD from Baseline to Month 24

  2. Changes in Femoral Neck BMD +/- Treatment With Alendronate [ Time Frame: Baseline to Month 24 ]
    Percent Change in femoral neck BMD from Baseline to Month 24

  3. Changes in Total Hip BMD +/- Treatment With Alendronate [ Time Frame: Baseline to Month 24 ]
    Percent Change in total hip BMD from Baseline to Month 24

  4. Changes in Radiographic Texture Analysis (RTA) Integrated Root Mean Square (iRMS) From Baseline to Month 24 [ Time Frame: Baseline to Month 24 ]

    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


  5. Changes in Radiographic Texture Analysis (RTA) Feature Standard Deviation of Root Mean Square (sdRMS) From Baseline to Month 24 [ Time Frame: Baseline to Month 24 ]

    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.


  6. Changes in Radiographic Texture Analysis (RTA) Feature Integrated First Moment of the Power Spectrum (iFMP) From Baseline to Month 24 [ Time Frame: Baseline to Month 24 ]
    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.

  7. Changes in Radiographic Texture Analysis (RTA) Minimum First Moment of the Power Spectrum (minFMP) From Baseline to Month 24 [ Time Frame: Baseline to Month 24 ]
    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.

  8. Changes in Radiographic Texture Analysis (RTA) Minkowski Fractal Dimension (MINK) From Baseline to Month 24 [ Time Frame: Baseline to Month 24 ]
    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.

  9. Changes in Radiographic Texture Analysis (RTA) Spectral Density Coefficient Beta (BETA) From Baseline to Month 24 [ Time Frame: Baseline to Month 24 ]
    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).



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Ages Eligible for Study:   59 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00145977


Locations
United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
National Institutes of Health (NIH)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
Principal Investigator: Tamara Vokes, MD University of Chicago

Publications:
National Osteoporosis Foundation: Physicians guide to prevention and treatment of osteoporosis, . 1999, Exerpta Medica, Inc.: Belle Mead, New Jersey.
Maragos, P., Fractal signal analysis using mathematicl morphology. Advances in Electronics and Electron Physics, 1994. 88: p. 199-246.

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00145977     History of Changes
Other Study ID Numbers: IRB# 11009B
NIH AR42739 ( Other Grant/Funding Number: NIH )
NIH AR42739-S1 ( Other Grant/Funding Number: NIH )
1K23AR048205 ( U.S. NIH Grant/Contract )
First Posted: September 5, 2005    Key Record Dates
Results First Posted: September 11, 2018
Last Update Posted: September 11, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Chicago:
osteoporosis
bone density
women
endocrine
musculoskeletal
metabolic

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Osteoporosis, Postmenopausal
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Vitamins
Vitamin D
Ergocalciferols
Calcium, Dietary
Alendronate
Citric Acid
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action