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NCT00001973
Studies on Abnormal Bone From Patients With Polyostotic Fibrous Dysplasia and McCune Albright Syndrome
trial in Polyostotic Fibrous Dysplasia. Completed in 12 December 2008.
Quick facts
| Lead sponsor | National Institute of Dental and Craniofacial Research (NIDCR) |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Start date | 18 December 1996 |
| Estimated completion | 12 December 2008 |
| Sites | 1 location across United States |
Conditions studied
- Polyostotic Fibrous Dysplasia — all drugs for Polyostotic Fibrous Dysplasia →
Sponsor
National Institute of Dental and Craniofacial Research (NIDCR)
Who can join
Eligibility, any sex, with Polyostotic Fibrous Dysplasia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00001973
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Related trials
Other National Institute of Dental and Craniofacial Research (NIDCR) trials
Trials by the same sponsor.
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- NCT05509595 — Burosumab for Fibroblast Growth Factor-23 Mediated Hypophosphatemia in Fibrous Dysplasia · Phase 2 · completed
- NCT05419050 — Study of Denosumab for Prevention of Skeletal Disease Progression in Children With Fibrous Dysplasia · Phase 2 · completed
- NCT04496960 — Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren's Syndrome · Phase 1, PHASE2 · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00001973 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Institute of Dental and Craniofacial Research (NIDCR)
- Last refreshed: 2 July 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00001973.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing