Trial · NCT03571191
Denosumab Treatment for Fibrous Dysplasia
NCT03571191, Phase 2, Active not recruiting, National Institute of Dental and Craniofacial Research (NIDCR)
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Denosumab Treatment for Fibrous Dysplasia. Trials, record NCT03571191. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03571191
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Denosumab Treatment for Fibrous Dysplasia
- NCT number
- NCT03571191
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 9 participants, actual
- Lead sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)
- Conditions
- Bone Diseases, Pain
- Interventions
- Denosumab
- First posted
- 2018-06-27
- Last updated
- 2022-02-18
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Primary:1. Assessment of markers of bone turnover: Beta-crosslaps, C-telopeptides (bone resorption marker,Procollagen-1-propeptide (bone formation marker) | every 3 months | 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 | Secondary outcome #1- Bone histomorphometric indices: (SqrRoot) Mineralized perimeter, (SqrRoot) Bone formation rate (SqrRoot) Cortical width (SqrRoot) Cortical area (SqrRoot) Osteoid width... | 2 time points | |
| Secondary | Secondary endpoint #3 - Pain assessments utilizing the Brief Pain Inventory scores | 2 time points | |
| Secondary | Secondary Endpoint #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 od cell senescence), and/or apoptosis index-Sen... | 2-4 timepoints | |
| Secondary | Exploratory endpoint #3 - Effect measured by change in other outcome measures(SqrRoot) Bone density assessed by DXA(SqrRoot) Physical Medicine and Rehabilitation evaluation | Q 3 mths/Q 6 mths | |
| Secondary | Exploratory endpoint #2 - Denosumab discontinuation effect on:(SqrRoot) Biochemical markers of bone metabolism: beta-crosslaps C-telopeptides, procollagen-1 propeptide, bone specific alkaline phosphatase, osteocalcin, NTX-telopeptides | every 3 months | |
| Secondary | Exploratory Endpoint # 1. Effect of denosumab initiation and discontinuation on(SqrRoot) Serum calcium, phosphorus and parathyroid hormone (SqrRoot) Serum circulating RANKL and osteoprotegerin (OPG), and RANKL/OPG level... | up to12 timepoints |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03571191
GET https://conductscience.org/api/trials/v1/NCT03571191/registered