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Sponsored by: |
Hadassah Medical Organization |
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Information provided by: | Hadassah Medical Organization |
ClinicalTrials.gov Identifier: | NCT00402064 |
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
Condition |
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Oral Cavity Osteomyelitis Necrosis of the Jaws |
Study Type: | Observational |
Official Title: | The Influence of Bisphosphonates in the Oral Cavity in Children |
Estimated Enrollment: | 60 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | December 2007 |
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 Materials and methods Population: 50 children treated with bisphosphonate will be included in the study.
The following data will be recorded:
Ages Eligible for Study: | 2 Years to 20 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
children treated with bisphosphonate who attend at the pediatric department of hadassah hospital and or to alyn hospital
Inclusion Criteria:
Contact: diana ram, DMD | 972-544-747580 | dianar@md.huji.ac.il |
Contact: Esti Davidovich, DMD, MSC | 972-507-323993 | dr-st@012.net.il |
Israel | |
Hadassah scool of Dental Medicine | Recruiting |
Jerusalem, Israel, 91120 | |
Contact: Diana Ram, DMD 97226776120 dianar@ekmd.huji.ac.il | |
Principal Investigator: diana ram, DMD |
Study Director: | diana ram, DMD | lecturer, the Hebrew university, Hadassa school of dental medicine |
Responsible Party: | Hadassah Medical Organization ( Hadassah Medical Organization ) |
Study ID Numbers: | st1975-HMO-CTIL |
Study First Received: | November 20, 2006 |
Last Updated: | December 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00402064 |
Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
bisphosphonates children dental |
Osteomyelitis children medication |
Tooth Diseases Necrosis Diphosphonates Musculoskeletal Diseases |
Stomatognathic Diseases Bone Diseases Dental Caries Osteomyelitis |
Pathologic Processes Physiological Effects of Drugs Bone Density Conservation Agents Infection |
Pharmacologic Actions Tooth Demineralization Bone Diseases, Infectious |