Osteoporosis Research Registry

Tracking Information
First Submitted Date	October 14, 2010
First Posted Date	October 18, 2010
Last Update Posted Date	December 19, 2016
Study Start Date	November 2008
Actual Primary Completion Date	December 2016 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: October 14, 2010)	BMD [ Time Frame: 0 months ]
Original Primary Outcome Measures	Same as current
Change History	Complete list of historical versions of study NCT01223300 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures; (submitted: October 14, 2010)	Bone markers [ Time Frame: 0 months ]
Original Secondary Outcome Measures	Same as current
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Osteoporosis Research Registry
Official Title	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	Observational
Study Design	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	Osteoporosis
Intervention	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	Completed
Actual Enrollment; (submitted: December 16, 2016)	12
Original Estimated Enrollment; (submitted: October 14, 2010)	200
Actual Study Completion Date	December 2016
Actual Primary Completion Date	December 2016 (Final data collection date for primary outcome measure)
Eligibility Criteria	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	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	United States
Removed Location Countries
Administrative Information
NCT Number	NCT01223300
Other Study ID Numbers	STU00007523
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Thomas J. Schnitzer, Northwestern University
Study Sponsor	Northwestern University
Collaborators	Shirley Ryan AbilityLab
Investigators	Principal Investigator: Thomas J Schnizter, M.D., PhD Northwestern University
PRS Account	Northwestern University
Verification Date	December 2016