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Texture Analysis for Postmenopausal Osteoporosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2007 by University of Chicago.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by:
University of Chicago
ClinicalTrials.gov Identifier:
NCT00145977
First received: September 1, 2005
Last updated: March 16, 2007
Last verified: March 2007
History of Changes
  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 70mg

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial 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:

U.S. FDA Resources

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • central BMD of the lumbar spine, proximal femur, total hip
  • peripheral BMD of the heel
  • results of texture analysis of the PIXI images
  • For assessment of bone turnover:
  • Bone Formation Markers
  • serum osteocalcin
  • BSAP as a markers of bone formation
  • Bone resorption Markers
  • urinary NTx and serum CTx
  • Serum osteocalcin
  • immunoradiometric assay

Estimated Enrollment: 40
Study Start Date: July 2001
Estimated Study Completion Date: July 2010
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   59 Years and older
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00145977

Contacts
Contact: Tamara Vokes, MD 773-702-1465 tvokes@medicine.bsd.uchicago.edu
Contact: Ann Pham 773-702-1197 apham@medicine.bsd.uchicago.edu

Locations
United States, Illinois
The University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Tamara Vokes, MD     773-702-1465     tvokes@medicine.bsd.uchicago.edu    
Contact: Ann Pham     773-702-1197     apham@medicine.bsd.uchicago.edu    
Principal Investigator: Tamara Vokes, MD            
Sponsors and Collaborators
University of Chicago
National Institutes of Health (NIH)
Investigators
Principal Investigator: Tamara Vokes, MD University of Chicago
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00145977     History of Changes
Other Study ID Numbers: IRB# 11009B, NIH AR42739, NIH AR42739-S1, NIH K23
Study First Received: September 1, 2005
Last Updated: March 16, 2007
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases
Musculoskeletal Diseases
 Alendronate
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 16, 2012