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NCT00017927 · ClinicalTrials.gov registry record · Phase 3
A Study of the Effects of Pegvisomant on Growth Hormone Excess in McCune-Albright Syndrome
A Phase 3 study of McCune Albright Syndrome and Polyostotic Fibrous Dysplasia, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
- Completed
- Registry status
- Phase 3
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT00017927 is a Phase 3 study of McCune Albright Syndrome and Polyostotic Fibrous Dysplasia that has completed, run by National Institute of Dental and Craniofacial Research (NIDCR). The registered enrollment target is 10 participants, below the 374-participant average among 3 other McCune Albright Syndrome trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00017927, a Phase 3 study of McCune Albright Syndrome and Polyostotic Fibrous Dysplasia, has completed, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will examine the effect of pegvisomant on growth hormone excess in patients with McCune-Albright syndrome (MAS). Patients with this disease have polyostotic fibrous dysplasia-a condition in which areas of normal bone are replaced with fibrous growth similar to scar tissue, abnormal skin pigmentation (birth marks) and precocious (early) puberty. About 10 percent of patients have excess growth hormone (GH). GH stimulates the production of another hormone called insulin-like growth factor 1 (IGF-1). Together, GH and IGF-1 affect bone growth. The excess of these hormones in MAS can cause overgrowth of the bones of the face, hands and feet, excess sweating, or increased height. Pegvisomant is a synthetic drug that binds to cell receptors where GH would normally bind, thus preventing the naturally occurring hormone from stimulating IGF-1 and bone growth as it normally would. This study will see if pegvisomant will reduce blood levels of IGF-1 and mitigate the effects of growth hormone excess, including bone pain, bone turnover, hand and foot swelling and sweating, and abnormal levels of related hormones. Patients who were screened for polyostotic fibrous dysplasia and MAS under NIH protocol 98-D-0145 and were found to have MAS with excess growth hormone are eligible for this 36-week study. The screening protocol includes a history and physical examination, blood and urine tests, hearing, eye and dental examinations, pain and physical function evaluations, endocrine and bone screening tests, various bone imaging studies, including magnetic resonance imaging (MRI) and computed tomography (CT) scans and bone biopsy in patients over 6 years old. Participants in the current study will receive daily injections of either pegvisomant or placebo (an inactive substance) for 12 weeks, followed by a 6-week "washout" period with no drug. Then, patients who received placebo will be switched, or "crossed over," to receive pegvisomant for another 12 weeks, and those who rec
Conditions Studied
Interventions
- DRUG Pegvisomant
Study Locations (1)
Maryland
- National Institute of Dental And Craniofacial Research (NIDCR) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2001-06 |
| Est. Completion | 2005-06 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00017927
The ClinicalTrials.gov registry entry for NCT00017927 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 374-participant average among 3 other McCune Albright Syndrome trials with a reported enrollment target (97% lower). 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 2 conditions, with McCune Albright Syndrome appearing as the primary indexed condition, and to 1 intervention - of which Pegvisomant is the first listed.
NCT00017927 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00017927 about?
NCT00017927 is a clinical study titled "A Study of the Effects of Pegvisomant on Growth Hormone Excess in McCune-Albright Syndrome". This study will examine the effect of pegvisomant on growth hormone excess in patients with McCune-Albright syndrome (MAS). Patients with this disease have polyostotic fibrous dysplasia-a condition in which areas of normal bone are replaced with fibrous growth similar to scar tissue, abnormal skin p...
What is the current status of trial NCT00017927?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 10 participants. The study started on 2001-06. Estimated completion is 2005-06.
What conditions does trial NCT00017927 study?
This clinical trial studies the following conditions: McCune Albright Syndrome, Polyostotic Fibrous Dysplasia.
What interventions are being tested in trial NCT00017927?
The interventions under investigation include: Pegvisomant (DRUG).
Who is sponsoring clinical trial NCT00017927?
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 NCT00017927 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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