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The Influence of Bisphosphonates in the Oral Cavity in Children
This study is currently recruiting participants.
Verified by Hadassah Medical Organization, June 2008
Sponsored by: Hadassah Medical Organization
Information provided by: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00402064
  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

U.S. FDA Resources
Study Type: Observational
Official Title: The Influence of Bisphosphonates in the Oral Cavity in Children

Further study details as provided by Hadassah Medical Organization:

Estimated Enrollment: 60
Study Start Date: March 2007
Estimated Study Completion Date: December 2007
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

Ages Eligible for Study:   2 Years to 20 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00402064

Contacts
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

Locations
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            
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 ( 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

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

Study placed in the following topic categories:
Tooth Diseases
Necrosis
Diphosphonates
Musculoskeletal Diseases
Stomatognathic Diseases
Bone Diseases
Dental Caries
Osteomyelitis

Additional relevant MeSH terms:
Pathologic Processes
Physiological Effects of Drugs
Bone Density Conservation Agents
Infection
Pharmacologic Actions
Tooth Demineralization
Bone Diseases, Infectious

ClinicalTrials.gov processed this record on January 14, 2009