The Influence of Bisphosphonates in the Oral Cavity in Children
1 other identifier
observational
60
1 country
1
Brief Summary
The use of bisphosphonates during childhood to ameliorate the skeletal abnormalities associated with osteogenesis imperfecta, idiopathic juvenile osteoporosis, fibrous dysplasia of bone and cerebral palsy. There is paucity of long-term studies among children regarding the safety and efficacy of bisphosphonates. Osteomyelitis and necrosis of the jaws has been was discovered and reported as a serious adverse event in bisphosphonate-treated adults patients. To our knowledge, there is no report in the literature about osteomyelitis in children treated with bisphosphonates and the influence of long term treatment with bisphosphonates on children's jaws, the reaction to extractions and on the oral cavity. Aim of the study: to examine the influence in the oral cavity of bisphosphonate in children
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 20, 2006
CompletedFirst Posted
Study publicly available on registry
November 22, 2006
CompletedStudy Start
First participant enrolled
March 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedJanuary 29, 2009
January 1, 2009
November 20, 2006
January 28, 2009
Conditions
Keywords
Eligibility Criteria
children treated with bisphosphonate who attend at the pediatric department of hadassah hospital and or to alyn hospital
You may qualify if:
- children treated with bisphosphonate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hadassah scool of Dental Medicine
Jerusalem, 91120, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
diana ram, DMD
lecturer, the Hebrew university, Hadassa school of dental medicine
Study Design
- Study Type
- observational
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 20, 2006
First Posted
November 22, 2006
Study Start
March 1, 2007
Study Completion
December 1, 2008
Last Updated
January 29, 2009
Record last verified: 2009-01