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The Influence of Bisphosphonates in the Oral Cavity in Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00402064
First Posted: November 22, 2006
Last Update Posted: January 29, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hadassah Medical Organization
  Purpose

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
Oral Cavity Osteomyelitis Necrosis of the Jaws

Study Type: Observational
Official Title: The Influence of Bisphosphonates in the Oral Cavity in Children

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Estimated Enrollment: 60
Study Start Date: March 2007
Estimated Study Completion Date: December 2008
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
children treated with bisphosphonate who attend at the pediatric department of hadassah hospital and or to alyn hospital
Criteria

Inclusion Criteria:

  • children treated with bisphosphonate
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00402064


Locations
Israel
Hadassah scool of Dental Medicine
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Study Director: diana ram, DMD lecturer, the Hebrew university, Hadassa school of dental medicine
  More Information

Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00402064     History of Changes
Other Study ID Numbers: st1975-HMO-CTIL
First Submitted: November 20, 2006
First Posted: November 22, 2006
Last Update Posted: January 29, 2009
Last Verified: January 2009

Keywords provided by Hadassah Medical Organization:
bisphosphonates
children
dental
Osteomyelitis
medication

Additional relevant MeSH terms:
Necrosis
Osteomyelitis
Pathologic Processes
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs