Trial · NCT05509595
Burosumab for Fibroblast Growth Factor-23 Mediated Hypophosphatemia in Fibrous Dysplasia
NCT05509595, Phase 2, Completed, National Institute of Dental and Craniofacial Research (NIDCR); results first posted 2026-02-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Burosumab for Fibroblast Growth Factor-23 Mediated Hypophosphatemia in Fibrous Dysplasia. Trials, record NCT05509595. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05509595
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Burosumab for Fibroblast Growth Factor-23 Mediated Hypophosphatemia in Fibrous Dysplasia
- NCT number
- NCT05509595
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 12 participants, actual
- Lead sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)
- Conditions
- Fibrous Dysplasia Of Bone
- Interventions
- Burosumab
- First posted
- 2022-08-22
- Last updated
- 2026-02-02
- Results first posted
- 2026-02-02
Source ClinicalTrials.gov
Registered outcomes35
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Participants With Serum Phosphate Levels Within the Target Range at Week 48 | Week 48 | The proportion of participants who achieved serum phosphate levels within the target range (Z-score -1 to +2) at week 48. Analysis was done by dividing the number of number of participants who achieved serum level by the number of participants analyzed. |
| Secondary | Participants With Adverse Event by Grade | 48 weeks for adult participants; 50 weeks for pediatric participants | Number participants with any adverse events by grade, up to 4 weeks after the final burosumab dose, was assessed using the National Cancer Institute (NCI), Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age appropriate instrumental ADL. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. |
| Secondary | Participants With Related Adverse Event | 48 weeks for adult participants; 50 weeks for pediatric participants | Participants with related adverse events up to 4 weeks after the final burosumab dose (48 weeks for adult subjects, 50 weeks for pediatric subjects). Adverse event was assessed using the National Cancer Institute (NCI), Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0. Related adverse event means that there are available evidence that suggests that there is a reasonable possibility that the study drug caused the adverse event. |
| Secondary | Proportion of Participants With Serum Phosphate Levels Within the Target Range at Week 24 | Week 24 | The proportion of participants who achieved serum phosphate levels within the target range (Z-score -1 to +2) at week 24. Analysis was done by dividing the number of number of participants who achieved serum level by the number of participants analyzed. |
| Secondary | Proportion of Participants With Serum Phosphate Levels Above the Target Range (Z-score >+2) | Between baseline and week 48 | The proportion of participants who achieved serum phosphate levels above the target range (Z-score \>+2) at any timepoint between baseline and week 48. Analysis was done by dividing the number of number of participants who achieved serum level above the target range by the number of participants analyzed. |
| Secondary | Change in Serum Phosphate Level | Week 48 minus baseline | Change in serum phosphate level from baseline to week 48. Measurements were taken at baseline and week 48. Analysis was done as change in median value between baseline and week 48. Change = week 48 minus baseline. |
| Secondary | Percent Change in Serum Phosphate Level | Week 48 minus baseline | Percent change in serum phosphate level from baseline to week 48. Measurements were taken at baseline and week 48. Analysis was done as percent change in median value between baseline and week 48. Change = week 48 minus baseline. |
| Secondary | Change in Serum 1,25-dihydroxyvitamin D Level | Week 48 minus baseline | Change in serum 1,25-dihydroxyvitamin D level from baseline to week 48. Measurements were taken at baseline and week 48. Analysis was done as change in median value between baseline and week 48. Change = week 48 minus baseline. |
| Secondary | Percent Change in Serum 1,25-dihydroxyvitamin D Level | Week 48 minus baseline | Percent change in serum 1,25-dihydroxyvitamin D level from baseline to 48 weeks. Measurements were taken at baseline and week 48. Analysis was done as percent change in median value between baseline and week 48. Change = 48 weeks minus baseline. |
| Secondary | Change in Serum Ratio of Renal Tubular Maximum Reabsorption Rate of Phosphate to Glomerular Filtration Rate (TmP/GFR) | Week 48 minus baseline | Change in serum ratio of renal tubular maximum reabsorption rate of phosphate to glomerular filtration rate (TmP/GFR) from baseline to week 48. Measurements were taken at baseline and week 48. Analysis was done as change in median value between baseline and week 48. Change = week 48 minus baseline. |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 registered outcomesOutcomes35
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Participants With Serum Phosphate Levels Within the Target Range at Week 48 | Week 48 | Modified intent to treat population | Proportion of participant | NUMBER |
| SECONDARY | Participants With Adverse Event by Grade | 48 weeks for adult participants; 50 weeks for pediatric participants | Modified intent to treat population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants With Related Adverse Event | 48 weeks for adult participants; 50 weeks for pediatric participants | Modified intent to treat population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Participants With Serum Phosphate Levels Within the Target Range at Week 24 | Week 24 | Modified intent to treat population | Proportion of participants | NUMBER |
| SECONDARY | Proportion of Participants With Serum Phosphate Levels Above the Target Range (Z-score >+2) | Between baseline and week 48 | Modified intent to treat population | Proportion of participants | NUMBER |
| SECONDARY | Change in Serum Phosphate Level | Week 48 minus baseline | Modified intent to treat population | mg/dL | MEDIAN |
| SECONDARY | Percent Change in Serum Phosphate Level | Week 48 minus baseline | Modified intent to treat population | Percentage of change | MEDIAN |
| SECONDARY | Change in Serum 1,25-dihydroxyvitamin D Level | Week 48 minus baseline | Modified intent to treat population | ng/mL | MEDIAN |
| SECONDARY | Percent Change in Serum 1,25-dihydroxyvitamin D Level | Week 48 minus baseline | Modified intent to treat population | Percentage of change | MEDIAN |
| SECONDARY | Change in Serum Ratio of Renal Tubular Maximum Reabsorption Rate of Phosphate to Glomerular Filtration Rate (TmP/GFR) | Week 48 minus baseline | Modified intent to treat population | mmol/L | MEDIAN |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 outcomesResults by group99
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Participants With Serum Phosphate Levels Within the Target Range at Week 48 | Treatment With Burosumab | 1 | Proportion of participant | ||
| Participants With Adverse Event by Grade | Treatment With Burosumab | Grade 1 | 9 | Participants | |
| Participants With Adverse Event by Grade | Treatment With Burosumab | Grade 2 | 6 | Participants | |
| Participants With Adverse Event by Grade | Treatment With Burosumab | Grade 3 | 1 | Participants | |
| Participants With Adverse Event by Grade | Treatment With Burosumab | Grade 4 | 0 | Participants | |
| Participants With Adverse Event by Grade | Treatment With Burosumab | Grade 5 | 0 | Participants | |
| Participants With Related Adverse Event | Treatment With Burosumab | 8 | Participants | ||
| Proportion of Participants With Serum Phosphate Levels Within the Target Range at Week 24 | Treatment With Burosumab | 0.92 | Proportion of participants | ||
| Proportion of Participants With Serum Phosphate Levels Above the Target Range (Z-score >+2) | Treatment With Burosumab | 0.5 | Proportion of participants | ||
| Change in Serum Phosphate Level | Treatment With Burosumab | 1.5 | Full Range 0.8 to 2.2 | mg/dL |
1 to 10 of 99Source ClinicalTrials.gov
See all 99 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment With Burosumab | 12 | |
| Overall Study | COMPLETED | Treatment With Burosumab | 12 | |
| Overall Study | NOT COMPLETED | Treatment With Burosumab | 0 |
Source ClinicalTrials.gov
Adverse events18
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Treatment With Burosumab | 1 | 12 | |
| other | Haemorrhoids | Gastrointestinal disorders | Treatment With Burosumab | 1 | 12 | |
| other | Injection site reaction | General disorders | Treatment With Burosumab | 3 | 12 | |
| other | Bacterial infection | Infections and infestations | Treatment With Burosumab | 1 | 12 | |
| other | Corona virus infection | Infections and infestations | Treatment With Burosumab | 1 | 12 | |
| other | Hypercalcaemia | Metabolism and nutrition disorders | Treatment With Burosumab | 1 | 12 | |
| other | Hyperphosphataemia | Metabolism and nutrition disorders | Treatment With Burosumab | 6 | 12 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Treatment With Burosumab | 1 | 12 | |
| other | Bone pain | Musculoskeletal and connective tissue disorders | Treatment With Burosumab | 1 | 12 | |
| other | Urinary tract infection | Renal and urinary disorders | Treatment With Burosumab | 1 | 12 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment With Burosumab | 0 | 12 |
| Total, other adverse events | Treatment With Burosumab | 12 | 12 |
| Total, serious adverse events | Treatment With Burosumab | 2 | 12 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT05509595
GET https://conductscience.org/api/trials/v1/NCT05509595/registered?page=2