- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00001973
Studies on Abnormal Bone From Patients With Polyostotic Fibrous Dysplasia and McCune Albright Syndrome
Studies on Tissues From Patients With Fibrous Dysplasia of Bone/McCune-Albright Syndrome and Other Disorders of Calcified Tissues
This study will investigate how a gene mutation (change in DNA) causes the abnormal bone in fibrous dysplasia-a condition in which areas of normal bone are replaced with a fibrous growth similar to a scar. The bone abnormalities in fibrous dysplasia can occur in a single bone (monostotic fibrous dysplasia), multiple bones (polyostotic fibrous dysplasia), or in McCune Albright syndrome, in which there are associated glandular abnormalities. This study will also examine calcinosis samples that have been surgically removed from patients with juvenile dermatomyositis.
Patients who are scheduled to have orthopedic surgery for treatment of polyostotic fibrous dysplasia may participate in this study. A small sample of bone tissue removed during surgery will be given to investigators in this study for research tests. DNA will be extracted from the tissue and tested for the mutation. Investigators will attempt to grow cells from the sample in the laboratory to evaluate them for their ability to grow and make proteins that normal bone cells make. These tests are designed to help scientists understand how the mutation leads to abnormal bone formation and provide information that might lead to better treatments for fibrous dysplasia. Patients with juvenile Dermatomyositis who have a calcinosis sample surgically removed are also eligible for participation. The removed tissues will be examined for their composition and microscopic appearance, to better understand the pathogenesis of dystrophic calcification in this disease.
Study Overview
Status
Conditions
Detailed Description
Study Type
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- INCLUSION CRITERIA:
All patients who are scheduled to have orthopedic surgery for treatment of polyostotic fibrous dysplasia (PFD).
Tissue will only be obtained from those patients in whom the procedure is clinically indicated for standard reasons such as treatment of or prevention of fractures, or disfigurement resulting from abnormal growth of facial and/ or skull bones.
The diagnosis of PFD will have been established by standard radiologic criteria and in patients with McCune Albright syndrome (MAS), also by the characteristic skin and endocrine manifestations associated with that form of the disease.
Patients meeting criteria for juvenile dermatomyositis who undergo surgical removal of calcinosis are eligible. The tissue from surgery would be used in the research study.
Study Plan
How is the study designed?
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 970055
- 97-D-0055
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Polyostotic Fibrous Dysplasia
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National Institute of Dental and Craniofacial Research...CompletedPolyostotic Fibrous DysplasiaUnited States
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National Institute of Dental and Craniofacial Research...CompletedPolyostotic Fibrous DysplasiaUnited States
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Eunice Kennedy Shriver National Institute of Child...CompletedPrecocious Puberty | Polyostotic Fibrous DysplasiaUnited States
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National Institute of Dental and Craniofacial Research...CompletedPrecocious Puberty | McCune Albright Syndrome | Polyostotic Fibrous DysplasiaUnited States
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Boston Children's HospitalNational Institutes of Health (NIH)Enrolling by invitation
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Hospices Civils de LyonCompletedFibrous Dysplasia of Bone | McCune Albright SyndromeFrance
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National Institute of Dental and Craniofacial Research...CompletedMcCune Albright Syndrome | Polyostotic Fibrous DysplasiaUnited States
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Tovah BursteinRecruitingFibrous Dysplasia | McCune Albright Syndrome | Mazabraud SyndromeUnited States
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National Institute of Dental and Craniofacial Research...RecruitingMcCune-Albright SyndromeUnited States
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Natasha Appelman-DijkstraRecruitingFibrous Dysplasia | McCune Albright SyndromeNetherlands