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NCT03571191 · ClinicalTrials.gov registry record · Phase 2
Denosumab Treatment for Fibrous Dysplasia
A Phase 2 study of Pain and Bone Diseases, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
- Active
- Registry status
- Phase 2
- Development phase
- 9
- Enrollment target
- 1
- Study location
NCT03571191 is a Phase 2 study of Pain and Bone Diseases that is active but no longer recruiting, run by National Institute of Dental and Craniofacial Research (NIDCR). The registered enrollment target is 9 participants, below the 304-participant average among 374 other Pain trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03571191, a Phase 2 study of Pain and Bone Diseases, is active but no longer recruiting, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 9 participants
- Enrollment target
- 1
- Study location
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 |
Interested in This Trial?
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, categorized as Phase 2. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 304-participant average among 374 other Pain 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 Pain appearing as the primary indexed condition, and to 1 intervention - of which Denosumab is the first listed.
NCT03571191 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
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.
What interventions are being tested in trial NCT03571191?
The interventions under investigation include: Denosumab (DRUG).
Who is sponsoring clinical trial NCT03571191?
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 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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Related
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