Healia Clinical Trials Information Database

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:

  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.

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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The Healia Clinical Trials Search Engine searches the data set at clinicaltrials.gov, providing up-to-date information about current clinical trials. In the Healia Clinical Trials Database you can find information on new experimental drugs, medical devices, and other types of treatments for all types of diseases. Each clinical trial description includes information about the phase of the trial (phase I, phase II, or phase III), the trial’s methods, such as whether it is a randomized, placebo controlled, double blind study, and the status of the trial including whether or not the trial is currently enrolling new participants.


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