NCT01587456

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

April 26, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 30, 2012

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

June 16, 2016

Status Verified

June 1, 2016

Enrollment Period

5 years

First QC Date

April 26, 2012

Last Update Submit

June 15, 2016

Conditions

Keywords

Osteoporosis

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Brabois Endocrinology

Vandœuvre-lès-Nancy, 54500, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Serum, Plasma and DNA

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Georges WERYHA, Professor

    CHU de Brabois Endocrinology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Georges WERYHA, MD, PHD

CONTACT

Anna KEARNEY SCHWARTZ, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2012

First Posted

April 30, 2012

Study Start

April 1, 2012

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

June 16, 2016

Record last verified: 2016-06

Locations