|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date † | January 14, 2008 | ||||||||
| Last Updated Date | September 16, 2008 | ||||||||
| Start Date † | December 2007 | ||||||||
| Current Primary Outcome Measures † |
establish complete database and publish descriptive paper [ Time Frame: 2 years ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures † | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00601068 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures † | |||||||||
| Original Secondary Outcome Measures † | |||||||||
| Descriptive Information | |||||||||
| Brief Title † | Proposal For The Development Of A Well Defined Database For Patients With Oral Bisphosphonate-Related Osteonecrosis | ||||||||
| Official Title † | Proposal For The Development Of A Well Defined Database For Patients With Oral Bisphosphonate-Related Osteonecrosis of the Jaws (BON) | ||||||||
| Brief Summary | In cooperation with Merck & Co, Inc. we will identify and form a database of 25-30 patients who have developed osteochemonecrosis of the jaws related to oral bisphosphonate use. We will study the triggers, associated medical conditions and medications, location of the lesion(s), and patient outcomes. |
||||||||
| Detailed Description | |||||||||
| Study Phase | |||||||||
| Study Type † | Observational | ||||||||
| Study Design † | Case-Only, Retrospective | ||||||||
| Condition † | Osteonecrosis | ||||||||
| Intervention † | Other: alendronate | ||||||||
| Study Arms / Comparison Groups | Group of patients with osteochemonecrosis related to oral bisphonate use | ||||||||
| Publications * | |||||||||
|
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Estimated Enrollment † | 30 | ||||||||
| Estimated Completion Date | December 2009 | ||||||||
| Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 30 Years to 90 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
|
||||||||
| Location Countries † | United States | ||||||||
| Expanded Access Status | |||||||||
| Administrative Information | |||||||||
| NCT ID † | NCT00601068 | ||||||||
| Responsible Party | Donald M. Cohen, Professor, PI, University of Florida | ||||||||
| Secondary IDs †† | 00065255 UFID | ||||||||
| Study Sponsor † | University of Florida | ||||||||
| Collaborators †† | Merck | ||||||||
| Investigators † |
|
||||||||
| Information Provided By | University of Florida | ||||||||
| Verification Date | September 2008 | ||||||||
|
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |
|||||||||
