Osteoporosis Research Registry | NCT01223300

Studies
Osteoporosis Research Registry

NCT01223300

Sponsor

Northwestern University

Status

Completed

Last Update Posted

Dec 19, 2016Estimated

Enrollment

12Actual

Phase

Not provided

Conditions

Osteoporosis

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2008

Primary Completion Date

Dec 2016Actual

Completion Date

Dec 2016Actual

First Submitted Date

Oct 14, 2010

First Submission Date that Met QC Criteria

Oct 14, 2010

First Posted Date

Oct 18, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 16, 2016

Last Update Posted Date

Dec 19, 2016Estimated

Name	Class
Shirley Ryan AbilityLab	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

12Actual

Label	Type	Description	Intervention Names
Osteoporosis

Measure	Description	Time Frame
BMD		0 months

Measure	Description	Time Frame
Bone markers		0 months

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thomas J Schnizter, M.D., PhD	Northwestern University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Northwestern University Feinberg School of Medicine		Chicago	Illinois	60611	United States

Condition Browse Module

MeSH Terms

ID	Term
D010024	Osteoporosis

Ancestor Terms

ID	Term
D001851	Bone Diseases, Metabolic
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided