Texture Analysis for Postmenopausal Osteoporosis

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT00145977
First received: September 1, 2005
Last updated: April 14, 2016
Last verified: April 2016
  Purpose
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 Intervention
Osteoporosis
Osteopenia
Drug: Alendronate
Drug: Control

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • changes in lumbar spine BMD +/- treatment with alendronate [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • changes in peripheral heel BMD +/- treatment with alendronate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • changes in femoral neck BMD +/- treatment with alendronate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • changes in total hip BMD +/- treatment with alendronate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • results of texture analysis of the PIXI images [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • changes in RTA feature iRMS +/- treatment with alendronate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • changes in RTA feature sdRMS +/- treatment with alendronate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • changes in RTA feature iFMP +/- treatment with alendronate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • changes in RTA feature minFMP +/- treatment with alendronate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • changes in RTA feature MINK +/- treatment with alendronate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • changes in RTA feature BETA +/- treatment with alendronate [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: July 2001
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: 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.
Other Name: fosamax
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.
Drug: Control
All subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal.
Other Name: Placebo

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   59 Years and older   (Adult, Senior)
Genders 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00145977     History of Changes
Other Study ID Numbers: IRB# 11009B  NIH AR42739  NIH AR42739-S1  1K23AR048205 
Study First Received: September 1, 2005
Last Updated: April 14, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Vitamins
Vitamin D
Ergocalciferols
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

ClinicalTrials.gov processed this record on July 28, 2016