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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: Active Phase 2 study of Pain and Bone Diseases, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).

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. According to ClinicalTrials.gov, the official US trial registry.

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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

Primary Outcome

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)

Conditions Studied

Pain Bone Diseases

Interventions

  • DRUG Denosumab

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center - Bethesda

Trial Details

FieldValue
Enrollment Target 9 participants
Start Date 2019-06-13
Est. Completion 2030-03-15
Phase Phase 2
National Institute of Dental and Craniofacial Research (NIDCR)

91 total trials

What the registry record for NCT03571191 still lists

NCT03571191 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 304-participant average among 374 other Pain trials with a reported enrollment target (97% lower).

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 a single indexed study location in 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.

Learn More About Clinical Trials

Similar trials for Pain

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03571191's enrollment target sits among peer trials

9 368th of 374 higher than 4 of 374 other Pain trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT03571191, the US trial registry maintained by the National Library of Medicine. NCT03571191 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.