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Trial record 24 of 293 for:    warfarin AND anticoagulation

The Relationship Between Osteoporosis and Chronic Oral Anticoagulation Therapy With Warfarin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00665613
Recruitment Status : Completed
First Posted : April 24, 2008
Last Update Posted : October 14, 2015
Sponsor:
Collaborator:
Staten Island University Hospital
Information provided by (Responsible Party):
Mario Castellanos, Northwell Health

Tracking Information
First Submitted Date April 22, 2008
First Posted Date April 24, 2008
Last Update Posted Date October 14, 2015
Study Start Date October 2004
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 5, 2013)
Bone Density [ Time Frame: 5 to 10 years ]
bone density as measured by xray to assess bone strength nd risk of fracture
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00665613 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Relationship Between Osteoporosis and Chronic Oral Anticoagulation Therapy With Warfarin
Official Title The Relationship Between Osteoporosis and Chronic Oral Anticoagulation Therapy With Warfarin
Brief Summary The purpose of this study is to determine if osteoporosis is an unrecognized complication of chronic anticoagulation with warfarin.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population patients on warfarintherapy in the SIUH coumadin center
Condition Osteoporosis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 5, 2013)
300
Original Estimated Enrollment
 (submitted: April 23, 2008)
3000
Actual Study Completion Date March 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients on warfarin that have had BMD within a year

Exclusion Criteria:

  • Patients on bisphosphates, SERMS, anticonvulsants, estrogens, androgens, calcitonin, hctz and thyroid hormone replacement
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 100 Years   (Adult, Older Adult)
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 NCT00665613
Other Study ID Numbers 04-054
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Mario Castellanos, Northwell Health
Study Sponsor Northwell Health
Collaborators Staten Island University Hospital
Investigators Not Provided
PRS Account Northwell Health
Verification Date October 2015