NCT00665613

Brief Summary

The purpose of this study is to determine if osteoporosis is an unrecognized complication of chronic anticoagulation with warfarin.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

October 1, 2004

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

April 22, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 24, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

October 14, 2015

Status Verified

October 1, 2015

Enrollment Period

4.4 years

First QC Date

April 22, 2008

Last Update Submit

October 13, 2015

Conditions

Osteoporosis

Keywords

warfarin use

Outcome Measures

Primary Outcomes (1)

  • Bone Density

    bone density as measured by xray to assess bone strength nd risk of fracture

    5 to 10 years

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients on warfarintherapy in the SIUH coumadin center

You may qualify if:

  • Patients on warfarin that have had BMD within a year

You may not qualify if:

  • Patients on bisphosphates, SERMS, anticonvulsants, estrogens, androgens, calcitonin, hctz and thyroid hormone replacement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Staten Island University Hospital

Staten Island, New York, 10305, United States

Location

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Director of Research for Dept. of Medicine

Study Record Dates

First Submitted

April 22, 2008

First Posted

April 24, 2008

Study Start

October 1, 2004

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

October 14, 2015

Record last verified: 2015-10

Locations

US(1)