Texture Analysis for Postmenopausal Osteoporosis

This study is currently recruiting participants.

Verified by University of Chicago, March 2007

Sponsors and Collaborators:	University of Chicago National Institutes of Health (NIH)
Information provided by:	University of Chicago
ClinicalTrials.gov Identifier:	NCT00145977

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

MedlinePlus related topics: Osteoporosis

Drug Information available for: Alendronate Alendronate sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Factorial Assignment, Efficacy Study
Official Title:	Changes in Bone Density, Radiographic Texture Analysis and Bone Turnover During Two Years of Antiresorptive Therapy for Postmenopausal Osteoporosis

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

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

Keywords provided by University of Chicago:

osteoporosis
bone density
women

endocrine
musculoskeletal
metabolic

Study placed in the following topic categories:

Musculoskeletal Diseases
Alendronate
Osteoporosis, Postmenopausal

Osteoporosis
Bone Diseases, Metabolic
Bone Diseases

Additional relevant MeSH terms:

Physiological Effects of Drugs
Bone Density Conservation Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009