Osteoporosis Research Registry
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ClinicalTrials.gov Identifier: NCT01223300 |
Recruitment Status
:
Completed
First Posted
: October 18, 2010
Last Update Posted
: December 19, 2016
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Sponsor:
Northwestern University
Collaborator:
Shirley Ryan AbilityLab
Information provided by (Responsible Party):
Thomas J. Schnitzer, Northwestern University
Tracking Information | ||||
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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 |
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 |
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 |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Retention: Samples With DNA Description: Two (10 ml) blood samples |
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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. |
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Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment |
12 | |||
Original Estimated Enrollment |
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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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PRS Account | Northwestern University | |||
Verification Date | December 2016 |