Trial · NCT02304367
Outcomes51
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 51
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Achieving Mean Serum Phosphorus Levels Above 2.5 mg/dL at the Mid-Point of the Dose Intervals Between Baseline and Week 24 | Mid-point of each dose interval from Baseline to Week 24 (Weeks 2, 6, 10, 14 and 22 [there was no study visit at Week 18]) | TIO analysis set: includes participants with TIO who received at least 1 dose of burosumab during the study. | percentage of participants | NUMBER |
| PRIMARY | Change From Baseline to Week 48 in Osteoid Thickness | Baseline, Week 48 | TIO bone biopsy analysis set | µm | MEAN |
| PRIMARY | Change From Baseline to Week 48 in Osteoid Surface/Bone Surface (OS/BS) | Baseline, Week 48 | TIO biopsy analysis set | percentage of bone surface | MEAN |
| PRIMARY | Change From Baseline to Week 48 in Osteoid Volume/Bone Volume (OV/BV) | Baseline, Week 48 | TIO bone biopsy analysis set | percentage of bone volume | MEAN |
| PRIMARY | Change From Baseline to Week 48 in Mineralization Lag Time (MLt) | Baseline, Week 48 | TIO biopsy analysis set for whom Mlt could be calculated or imputed | days | MEAN |
| SECONDARY | Percentage of Participants Achieving Mean Serum Phosphorus Levels Above 2.5 mg/dL at the End of the Dose Intervals Between Baseline and Week 24 | End of each dose interval from Baseline to Week 24 (Weeks 4, 8, 12, 16, 20, and 24) | TIO analysis set | percentage of participants | NUMBER |
| SECONDARY | Mean Change From Baseline in Serum Phosphorus Levels at the Mid-Point of the Dose Interval, as Averaged Across Dose Cycles Between Baseline and Week 24 | Baseline and the mid-point of each dose interval from Baseline to Week 24 (Weeks 2, 6, 10, 14 and 22) | TIO analysis set | mg/dL | MEAN |
| SECONDARY | Percent Change From Baseline in Serum Phosphorus Levels at the Mid-Point of the Dose Interval, as Averaged Across Dose Cycles Between Baseline and Week 24 | Baseline and the mid-point of each dose interval from Baseline to Week 24 (Weeks 2, 6, 10, 14 and 22) | TIO analysis set | percent change | MEAN |
| SECONDARY | Mean Change From Baseline in Serum Phosphorus Levels at the End of the Dosing Cycle, as Averaged Across Dose Cycles Between Baseline and Week 24 | Baseline and Weeks 4, 8, 12, 16, 20, and 24 | TIO analysis set | mg/dL | MEAN |
| SECONDARY | Percent Mean Change From Baseline in Serum Phosphorus Levels at the End of the Dosing Cycle, as Averaged Across Dose Cycles Between Baseline and Week 24 | Baseline and Weeks 4, 8, 12, 16, 20, and 24 | TIO analysis set | percent change | MEAN |
| SECONDARY | Time-Adjusted Area Under the Curve (AUC) of Serum Phosphorus Levels Between Baseline and Week 24 | Pre-dose on Day 1 and at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 21, 22, and 24 | TIO analysis set | mg/dL | MEAN |
| SECONDARY | Change From Baseline Over Time in Serum 1,25-dihydroxyvitamin D (1,25(OH)2D) Concentration | Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240 | TIO analysis set participants with available data at Baseline and each time point. | pg/mL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline Over Time in Total Serum Fibroblast Growth Factor 23 (FGF23) Concentration | Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240 | TIO analysis set with available data at each time point | pg/mL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline Over Time in Free Serum Fibroblast Growth Factor 23 (FGF23) Concentration | Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240 | TIO analysis set with available data at each time point | pg/mL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline Over Time in 24-hour Urinary Phosphorus | Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240 | TIO analysis set participants with available data at each time point. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline Over Time in Tubular Reabsorption of Phosphate (TRP) | Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240 | TIO analysis set participants with available data at Baseline and each time point. | fraction of phosphorus reabsorbed | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline Over Time in Ratio of Renal Tubular Maximum Phosphate Reabsorption Rate to Glomerular Filtration Rate (TmP/GFR) | Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240 | TIO analysis set participants with available data at Baseline and each time point. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline Over Time in Fractional Excretion of Phosphorus (FEP) | Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240 | TIO analysis set participants with available data at each time point. | percentage of phosphorus | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline Over Time in Serum Alkaline Phosphatase (ALP) | Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240 | TIO analysis set participants with available data at each time point. | U/L | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline Over Time in Bone-Specific Alkaline Phosphatase (BALP) | Baseline and Weeks 24, 48, 96, 144, 168, 192, 216, and 240 | TIO analysis set participants with available data at each time point. | μg/L | LEAST_SQUARES_MEAN |
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.
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GET https://conductscience.org/api/trials/v1/NCT02304367/outcomes