Arteos II Study: Relationship Between Osteoporosis and Ar... | NCT01587456

Studies
Arteos II Study: Relationship Between Osteoporosis and Arterial Rigidity Within Fractured Patients Cohort

NCT01587456

Sponsor

Central Hospital, Nancy, France

Status

Unknown status

Last Update Posted

Jun 16, 2016Estimated

Enrollment

300Estimated

Phase

Not provided

Conditions

Osteoporosis

Interventions

Not provided

Countries

France

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

Jun 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2012

Primary Completion Date

Apr 2017Estimated

Completion Date

Apr 2017Estimated

First Submitted Date

Apr 26, 2012

First Submission Date that Met QC Criteria

Apr 27, 2012

First Posted Date

Apr 30, 2012Estimated

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

Jun 15, 2016

Last Update Posted Date

Jun 16, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 investigators planned to study relationship between osteoporosis and arterial rigidity within fractured patients cohort.

Detailed Description

Not provided

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

300Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

women and men > 60 years of age
medical history of low energy fracture
DXA Tscore -2,5 DS
FREE AND INFORMED CONSENT SIGNED

Exclusion Criteria:

women and men < 60 years of age
Corticoids treatment
Breast cancer or prostat cancer medical history
High energy fracture (traumatic fracture)
No social security affiliation
Incapacity to informed consent signed.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Women and men > 60 years of age with medical history of low energy fracture andradiologic osteoporosis with DXA Tscore at -2,5 DS.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Georges WERYHA, MD, PHD	Contact	33 3 83 15 35 05		g.weryha@chu-nancy.fr
Anna KEARNEY SCHWARTZ, MD	Contact	+33 3 83 15 33 22		a.kearney-schwartz@chu-nancy.fr

Overall Officials

Name	Affiliation	Role
Georges WERYHA, Professor	CHU de Brabois Endocrinology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Brabois Endocrinology	Recruiting	Vandœuvre-lès-Nancy		54500	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

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