OsteoporosisNCT00665613
The Relationship Between Osteoporosis and Chronic Oral Anticoagulation Therapy With Warfarin
An observational study of Osteoporosis, run by Northwell Health at 1 site in United States.
Trial summary
The purpose of this study is to determine if osteoporosis is an unrecognized complication of chronic anticoagulation with warfarin. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to Mar 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients on warfarintherapy in the SIUH coumadin center
Who may be able to join
- Patients on warfarin that have had BMD within a year
Who cannot join
- Patients on bisphosphates, SERMS, anticonvulsants, estrogens, androgens, calcitonin, hctz and thyroid hormone replacement
Trial locations and contacts
1 site in 1 country.
United States1 site
Staten Island University Hospital
Staten Island, New York, 10305
About this study
The purpose of this study is to determine if osteoporosis is an unrecognized complication of chronic anticoagulation with warfarin.
- Conditions
- Osteoporosis
- Keywords
- warfarin use
- Medical subject headings
- Osteoporosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Density
bone density as measured by xray to assess bone strength nd risk of fracture
Measured: 5 to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2008 (estimated)
- Study startOct 2004
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- Staten Island University Hospital
- Responsible party
- Principal investigator, Mario Castellanos, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00665613
- Sponsor's protocol ID
- 04-054
- Status last verified
- Oct 2015
- First submitted
- 22 Apr 2008
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Osteoporosis and Chronic Oral Anticoagulation Therapy With Warfarin
- ClinicalTrials.gov ID
- NCT00665613
- Acronym / sponsor ID
- 04-054
- Conditions
- Osteoporosis
- Keywords
- warfarin use
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- Staten Island University Hospital
- Study start
- Oct 2004
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 24 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if osteoporosis is an unrecognized complication of chronic anticoagulation with warfarin.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients on warfarintherapy in the SIUH coumadin center
Key inclusion criteria (1 listed)
- Patients on warfarin that have had BMD within a year
Key exclusion criteria (1 listed)
- Patients on bisphosphates, SERMS, anticonvulsants, estrogens, androgens, calcitonin, hctz and thyroid hormone replacement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bone Density
Time frame: 5 to 10 years
bone density as measured by xray to assess bone strength nd risk of fracture
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone Density (time frame: 5 to 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2015.