Trial · NCT05509595
Registered outcomes35
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 35
Download this page as JSON| 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. |
| Secondary | Percent Change in Serum Ratio of Renal Tubular Maximum Reabsorption Rate of Phosphate to Glomerular Filtration Rate (TmP/GFR) | Week 48 minus baseline | Percent 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 percent change in median value between baseline and week 48. Change = week 48 minus baseline. |
| Secondary | Change in Fibrous Dysplasia Lesion Activity Using Fluorine-18 Sodium Fluoride Positron Emission Tomography/Computed Tomography (18F-NaF PET/CT) Scan | Week 48 minus baseline | Change in fibrous dysplasia lesion activity using Fluorine-18 Sodium Fluoride Positron Emission Tomography/Computed Tomography (18F-NaF PET/CT) scan from baseline to week 48. 18F-NaF PET/CT scan was done at baseline and week 48 and total lesion activity units were calculated from each scan. Change in lesion activity was compared between timepoints, baseline and week 48. Change = 48 weeks minus baseline. |
| Secondary | Change in Serum Procollagen 1 N-terminal Propeptide (P1NP) Level | Week 48 minus baseline | Change in serum procollagen 1 N-terminal propeptide (P1NP) 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 Procollagen 1 N-terminal Propeptide (P1NP) Level | Week 48 minus baseline | Percent change in serum procollagen 1 N-terminal propeptide (P1NP) 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 Beta Crosslaps C-telopeptides (CTX) Level | Week 48 minus baseline | Change in serum beta crosslaps C-telopeptides (CTX) 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 Beta Crosslaps C-telopeptides (CTX) Level | Week 48 minus baseline | Percent change in serum beta crosslaps C-telopeptides (CTX) 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 Osteocalcin Level | Week 48 minus baseline | Change in serum osteocalcin 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 Osteocalcin Level | Week 48 minus baseline | Percent change in serum osteocalcin 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 Alkaline Phosphatase Level | Week 48 minus baseline | Change in serum alkaline phosphatase 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 Alkaline Phosphatase Level | Week 48 minus baseline | Percent change in serum alkaline phosphatase 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT05509595/registered