NCT00402064

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

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2007

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 22, 2006

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2007

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

January 29, 2009

Status Verified

January 1, 2009

First QC Date

November 20, 2006

Last Update Submit

January 28, 2009

Conditions

Keywords

bisphosphonateschildrendentalOsteomyelitismedication

Eligibility Criteria

Age2 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

Location

MeSH Terms

Conditions

Osteomyelitis

Condition Hierarchy (Ancestors)

Bone Diseases, InfectiousInfectionsBone DiseasesMusculoskeletal Diseases

Study Officials

  • diana ram, DMD

    lecturer, the Hebrew university, Hadassa school of dental medicine

    STUDY DIRECTOR

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

Locations