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The Influence of Bisphosphonates in the Oral Cavity in Children

The Influence of Bisphosphonates in the Oral Cavity in Children

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00402064
Enrollment
60
Registered
2006-11-22
Start date
2007-03-31
Completion date
2008-12-31
Last updated
2009-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Necrosis of the Jaws, Oral Cavity, Osteomyelitis

Keywords

bisphosphonates, children, dental, Osteomyelitis, medication

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

Detailed 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: 1. age, gender, initial disease, age at diagnosis, additional diseases 2. 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) 3. 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. 4. Unstimulated whole saliva was collected using the spitting method as previously described. Sialochemistry analysis will be performed. 5. 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.

Interventions

None listed

Sponsors

Hadassah Medical Organization
Lead SponsorOTHER

Eligibility

Sex/Gender
ALL
Age
2 Years to 20 Years
Healthy volunteers
No

Inclusion criteria

* children treated with bisphosphonate

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026