Polyostotic Fibrous Dysplasia Clinical Trial
Official title:
Studies on Tissues From Patients With Fibrous Dysplasia of Bone/McCune-Albright Syndrome and Other Disorders of Calcified Tissues
Verified date | December 12, 2008 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 0 |
Est. completion date | December 12, 2008 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
- 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. |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institute of Dental and Craniofacial Research (NIDCR) |
United States,
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