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Denosumab Treatment for Fibrous Dysplasia
NCT03571191 · View on ClinicalTrials.gov ↗
Study Summary
Objectives: The primary objective of this study is to evaluate the effect of denosumab on bone turnover in individuals with fibrous dysplasia (FD). Secondary objectives are to determine the effect of denosumab on bone pain, FD lesion intensity as revealed in 18F-sodium fluoride PET/CT bone scan, and to determine the effect of denosumab discontinuation on bone turnover re-bound after discontinuation. Study Population: Up to 14 adult subjects with FD may be enrolled to ensure complete study data on 9 subjects. Design: This study is a single center, open label pilot study of once-monthly dosing of denosumab. Subjects will be treated for 6 months, after which they will be followed by an 8-month observation period. A final visit will occur 21 months after denosumab discontinuation. Dosing will be adopted from studies in adults on treatment for giant cell tumors, with denosumab administered at 120 mg per dose every 4 weeks, with loading doses on days 7 and 14 of month 1. Outcome Measures: Primary: Assessment of the effects of denosumab on: 1\. Markers of bone turnover: Beta-crosslaps C-telopeptides (bone resorption marker) Procollagen-1-propeptide (bone formation marker) Secondary: Assessment of the effects of denosumab on: 1. Bone histomorphometric indices: Mineralized perimeter Bone formation rate Cortical width Cortical area Osteoid width Osteoid perimeter Mineral apposition rate 2. Surrogate markers of a direct therapeutic effect of denosumab on FD lesions: Semi-quantitative changes in RANKL, Ki67 (marker of cell proliferation), p16 (marker of cell senescence), and/or apoptosis index before and after treatment, as assessed by immunohistochemistry Changes in sentinel lesion intensity, measured quantitatively by uptake on 18Fsodium fluoride PET/CT bone scan. 3. FD-related bone pain assessed by the Brief Pain Inventory (Short Form) , a validated self-reporting tool for assessment of pain. Exploratory Endpoints: 1. Effec
Conditions Studied
Interventions
- DRUG Denosumab
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center — Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2019-06-13 |
| Est. Completion | 2030-03-15 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03571191
The ClinicalTrials.gov registry entry for NCT03571191 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Dental and Craniofacial Research (NIDCR), which has 60 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Pain appearing as the primary indexed condition, and to 1 intervention — of which Denosumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03571191 reports 1 study location spanning 1 distinct geographic area — top geographies include Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03571191 about?
NCT03571191 is a clinical study titled "Denosumab Treatment for Fibrous Dysplasia". Objectives: The primary objective of this study is to evaluate the effect of denosumab on bone turnover in individuals with fibrous dysplasia (FD). Secondary objectives are to determine the effect of denosumab on bone pain, FD lesion intensity as revealed in 18F-sodium fluoride PET/CT bone scan, an...
What is the current status of trial NCT03571191?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 9 participants. The study started on 2019-06-13. Estimated completion is 2030-03-15.
What conditions does trial NCT03571191 study?
This clinical trial studies the following conditions: Pain, Bone Diseases. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03571191?
The interventions under investigation include: Denosumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03571191?
This trial is sponsored by National Institute of Dental and Craniofacial Research (NIDCR), which has 60 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03571191 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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