Osteoporosis Research Registry

This study has been completed.

Sponsor:

Collaborator:

Shirley Ryan AbilityLab

Information provided by (Responsible Party):

Thomas J. Schnitzer, Northwestern University

ClinicalTrials.gov Identifier:

NCT01223300

First received: October 14, 2010

Last updated: December 16, 2016

Last verified: December 2016

History of Changes

Tracking Information

First Received Date ^ICMJE

October 14, 2010

Last Updated Date

December 16, 2016

Start Date ^ICMJE

November 2008

Primary Completion Date

December 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

BMD [ Time Frame: 0 months ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01223300 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Bone markers [ Time Frame: 0 months ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Osteoporosis Research Registry

Official Title ^ICMJE

Osteoporosis Research Registry

Brief Summary

The aim of this research registry is to collect information on individuals with osteoporosis, those with risk factors for osteoporosis, and comparative healthy controls. Bone mineral density measurements will be done on these individuals to determine bone health.

Detailed Description

The goal of this project is to develop a registry of research subjects with OP, with a risk of developing OP, and healthy controls. DXA scans will be performed on willing individuals at the spine, hips, and forearms and possibly the legs and heels in order to determine BMD. Subjects will also be asked to provide two (10 ml) blood samples, which may be used to analyze Vitamin D levels and/or other bone markers. By participating in the registry, subjects will be considered for current and future clinical research studies.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case-Only
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples With DNA

Description:

Two (10 ml) blood samples

Sampling Method

Non-Probability Sample

Study Population

Individuals with osteoporosis or at risk for osteoporosis. Also, healthy controls.

Condition ^ICMJE

Osteoporosis

Intervention ^ICMJE

Not Provided

Study Groups/Cohorts

Osteoporosis

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2016

Primary Completion Date

December 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Any subjects who give written informed consent

Exclusion Criteria:

Any individual who is not willing or able to give written informed consent

Sex/Gender

Sexes Eligible for Study:

All

Ages

Child, Adult, Senior

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01223300

Other Study ID Numbers ^ICMJE

STU00007523

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Thomas J. Schnitzer, Northwestern University

Study Sponsor ^ICMJE

Northwestern University

Collaborators ^ICMJE

Shirley Ryan AbilityLab

Investigators ^ICMJE

Principal Investigator:

Thomas J Schnizter, M.D., PhD

Northwestern University

PRS Account

Northwestern University

Verification Date

December 2016

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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