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NCT00001727 · ClinicalTrials.gov registry record
Screening and Natural History of Patients With Polyostotic Fibrous Dysplasia and the McCune-Albright Syndrome
A clinical trial of McCune Albright Syndrome, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
- Recruiting
- Registry status
- 500
- Enrollment target
- 1
- Study location
NCT00001727 is a study of McCune Albright Syndrome that is actively recruiting participants, run by National Institute of Dental and Craniofacial Research (NIDCR). The registered enrollment target is 500 participants, above the 211-participant average among 3 other McCune Albright Syndrome trials with a reported enrollment target (137% higher). The trial reports 1 study location across 1 state.
The verdict
NCT00001727, a study of McCune Albright Syndrome, is actively recruiting participants, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
- RECRUITING
- Registry status
- 500 participants
- Enrollment target
- 1
- Study location
Study Summary
Polyostotic fibrous dysplasia (PFD) is a sporadic disorder which affects multiple sites in the skeleton. The bone at these sites is rapidly resorbed and replaced by abnormal fibrous tissue or mechanically abnormal bone. PFD may occur alone or as part of the McCune-Albright Syndrome (MAS), a syndrome originally defined by the triad of PFD, cafe-au-lait pigmentation of the skin, and precocious puberty. The bony lesions are frequently disfiguring, disabling and painful, and depending on the location of the lesion, can cause significant morbidity. Lesions in weight-bearing bones can lead to disabling fractures, while lesions in the skull can lead to compression of vital structures such as cranial nerves. The natural history of this disease is poorly described and there are no clearly defined systemic therapies for the bone disease. This is a data collection and specimen acquisition protocol. The purpose of the study is to define the natural history of the disease by following PFD/MAS subjects over time and by using in vitro experimentation with samples/tissue from subjects with the disease. Study Objectives 1. Primary Objective Define the natural history of disease by gaining clinical and basic information about PFD/MAS by following subjects clinically and using in vitro experimentation with tissue from subjects with the disease. 2. Secondary Objective Refer eligible subjects for enrollment into other appropriate research protocols, if any are currently active. Study Population The study population will include: 1. Subjects with known or suspected Polyostotic Fibrous Dysplasia (PFD) or in combination with McCune-Albright Syndrome (MAS) 2. Subjects who meet eligibility criteria will be accepted regardless of gender, race, or ethnicity Design This study is an observational/natural history study of PFD/MAS. Outcome Measures Primary 1. Successfully enroll subjects with PFD or MAS for the collection, evaluation and analysis of data obtained from clinical visi
Conditions Studied
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 1998-12-13 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001727
The ClinicalTrials.gov registry entry for NCT00001727 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 500 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 211-participant average among 3 other McCune Albright Syndrome trials with a reported enrollment target (137% higher). The listed sponsor is National Institute of Dental and Craniofacial Research (NIDCR), which has 91 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with McCune Albright Syndrome appearing as the primary indexed condition, and to 0 interventions.
NCT00001727 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00001727 about?
NCT00001727 is a clinical study titled "Screening and Natural History of Patients With Polyostotic Fibrous Dysplasia and the McCune-Albright Syndrome". Polyostotic fibrous dysplasia (PFD) is a sporadic disorder which affects multiple sites in the skeleton. The bone at these sites is rapidly resorbed and replaced by abnormal fibrous tissue or mechanically abnormal bone. PFD may occur alone or as part of the McCune-Albright Syndrome (MAS), a syndrome...
What is the current status of trial NCT00001727?
This trial is currently recruiting. The enrollment target is 500 participants. The study started on 1998-12-13.
What conditions does trial NCT00001727 study?
This clinical trial studies the following conditions: McCune Albright Syndrome.
Who is sponsoring clinical trial NCT00001727?
This trial is sponsored by National Institute of Dental and Craniofacial Research (NIDCR), which has 91 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00001727 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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