The Influence of Bisphosphonates in the Oral Cavity in Children
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
Description
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:
age, gender, initial disease, age at diagnosis, additional diseases
duration and dosage of the bisphosphonate medication (kind of bisphosphonate, age at the beginning of the drug treatment, duration of treatment, frequency of intake, additional medications)
Clinical dental examination was performed for detection of; caries, gingival inflammation and oral hygiene, sequence of dental eruption, teeth extractions, and presence of exposure bone.
Unstimulated whole saliva was collected using the spitting method as previously described. Sialochemistry analysis will be performed.
Serum analysis findings including: calcium (Ca), phosphorous (P), alkaline phosphatase (AlP) and parathyroid hormone (PTH),vitamin D cross-linked telopeptides (ctx, ntx), bone density. (these examination are performed routinely, in these patients, as part of medical follow up.
Status: Completed (N/A). Started on March 1st, 2007. Ended on December 1st, 2008.
Enrollment: 60 subjects
Study Type: Observational
Study Design:
- Other
- Other
Conditions:
Interventions:
Eligibility
Inclusion Criteria:
- children treated with bisphosphonate
- Gender
Both
- Mininum Age
2 Years
- Maximum Age
20 Years
- Healthy Volunteers
No
Resources
Source: Hadassah Medical Organization
Authority: Israel: Israeli Health Ministry Pharmaceutical Administration
Locations
-
Hadassah scool of Dental Medicine
Jerusalem
91120
Israel
Officials
diana ram, DMD (Study Director, lecturer, the Hebrew university, Hadassa school of dental medicine)
Sponsors
Hadassah Medical Organization (Lead Sponsor)
References
None.
Links
None.
- Date Verified
- January 1st, 2009
- First Received
- January 28th, 2009
- Last Changed
- January 28th, 2009
Information obtained from ClinicalTrials.gov on January 29, 2009. Link to the current ClinicalTrials.gov record.
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