Studies on Abnormal Bone From Patients With Polyostotic Fibrous Dysplasia and McCune Albright Syndrome
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ClinicalTrials.gov Identifier: NCT00001973 |
Recruitment Status
:
Completed
First Posted
: January 19, 2000
Last Update Posted
: July 2, 2017
|
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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.
Condition or disease |
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Polyostotic Fibrous Dysplasia |
Study Type : | Observational |
Official Title: | Studies on Tissues From Patients With Fibrous Dysplasia of Bone/McCune-Albright Syndrome and Other Disorders of Calcified Tissues |
Study Start Date : | December 18, 1996 |
Study Completion Date : | December 12, 2008 |


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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
- 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.

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): NCT00001973
United States, Maryland | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | |
Bethesda, Maryland, United States, 20892 |
ClinicalTrials.gov Identifier: | NCT00001973 History of Changes |
Obsolete Identifiers: | NCT00001607 |
Other Study ID Numbers: |
970055 97-D-0055 |
First Posted: | January 19, 2000 Key Record Dates |
Last Update Posted: | July 2, 2017 |
Last Verified: | December 12, 2008 |
Keywords provided by National Institutes of Health Clinical Center (CC):
G Protein Mutation McCune-Albright Syndrome Fibrous Dysplasia Mutation Pathology |
Immunohistochemistry PCR In Situ Hybridization Juvenile Dermatomyositis Calcinosis |
Additional relevant MeSH terms:
Hyperplasia Fibrous Dysplasia, Polyostotic Fibrous Dysplasia of Bone Pathologic Processes |
Osteochondrodysplasias Bone Diseases, Developmental Bone Diseases Musculoskeletal Diseases |