Trial · NCT02537431
Open Label Study of KRN23 on Osteomalacia in Adults With X-linked Hypophosphatemia (XLH)
NCT02537431, Phase 3, Completed, Kyowa Kirin, Inc.; results first posted 2018-09-25
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Open Label Study of KRN23 on Osteomalacia in Adults With X-linked Hypophosphatemia (XLH). Trials, record NCT02537431. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02537431
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open Label Study of KRN23 on Osteomalacia in Adults With X-linked Hypophosphatemia (XLH)
- NCT number
- NCT02537431
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 14 participants, actual
- Lead sponsor
- Kyowa Kirin, Inc.
- Conditions
- X-linked Hypophosphatemia
- Interventions
- burosumab
- First posted
- 2015-09-01
- Last updated
- 2024-06-18
- Results first posted
- 2018-09-25
Source ClinicalTrials.gov
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in OV/BV at Week 48 | Baseline, 48 weeks | OV/BV: percent of a given volume of bone tissue that consists of unmineralized bone (osteoid). |
| Secondary | Percentage of Participants Achieving Mean Serum Phosphorus Levels Above the Lower Limit of Normal (LLN) at the Mid-Point of the Dose Interval, as Averaged Across Dose Cycles Between Baseline and Week 24 | Baseline, up to 24 weeks | The LLN was defined as 2.5 mg/dL (0.81 mmol/L). The 95% confidence interval (CI) was calculated using Wilson score method. |
| Secondary | Percent Change From Baseline in O.Th at Week 48 | Baseline, 48 weeks | O.Th: mean thickness, given in micrometers, for osteoid seams. |
| Secondary | Percent Change From Baseline in OS/BS at Week 48 | Baseline, 48 weeks | OS/Bs: percent of bone surface covered in osteoid. |
| Secondary | Percent Change From Baseline in MLt at Week 48 | Baseline, 48 weeks | MLt: average time interval between osteoid formation and its subsequent mineralization; calculated by dividing the osteoid thickness by the adjusted apposition rate (O.Th/Aj.AR). Aj.AR; amount of new bone created (bone formation rate over the entire osteoid surface). Based on imputed MLt values. |
| Secondary | Change From Baseline in MAR at Week 48 | Baseline, 48 weeks | MAR: linear rate of new bone deposition; mean distance between the double labels, divided by the time interval between them. |
| Secondary | Change From Baseline in MS/BS at Week 48 | Baseline, 48 weeks | MS/BS: percent of bone surface that displays a tetracycline label reflecting active mineralization; calculated as the double-labeled surface plus one half of the single-labeled surface and is expressed as a function of total bone surface (\[dLS + sLS/2\]/BS). It is a measure of the proportion of bone surface upon which new mineralized bone was being deposited during the period of tetracycline labeling. |
| Secondary | Change From Baseline in BFR/BS at Week 48 | Baseline, 48 weeks | BFR/BS: amount of new bone formed in unit time per unit of bone surface; calculated by multiplying MS/BS by the MAR. MS/BS: percent of bone surface that displays a tetracycline label reflecting active mineralization; calculated as the double-labeled surface plus one half of the single-labeled surface and is expressed as a function of total bone surface (\[dLS + sLS/2\]/BS). It is a measure of the proportion of bone surface upon which new mineralized bone was being deposited during the period of tetracycline labeling. MAR: linear rate of new bone deposition; mean distance between the double labels, divided by the time interval between them. |
| Secondary | Change From Baseline in BFR/OS at Week 48 | Baseline, 48 weeks | BFR/OS: bone formation rate to osteoid surface ratio, related to the Aj.AR (amount of new bone created \[bone formation rate over the entire osteoid surface\]). |
| Secondary | Change From Baseline in BFR/BV at Week 48 | Baseline, 48 weeks | BFR/BV: equivalent to bone turnover rate. |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 registered outcomesOutcomes26
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline in OV/BV at Week 48 | Baseline, 48 weeks | Primary Analysis Set: enrolled participants with baseline and follow-up (Week 48/end of treatment) bone biopsy data; participants with non-missing results. | percentage change of unmineralized bone | MEAN |
| SECONDARY | Percentage of Participants Achieving Mean Serum Phosphorus Levels Above the Lower Limit of Normal (LLN) at the Mid-Point of the Dose Interval, as Averaged Across Dose Cycles Between Baseline and Week 24 | Baseline, up to 24 weeks | Full Analysis Set: all enrolled participants who receive at least one dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Percent Change From Baseline in O.Th at Week 48 | Baseline, 48 weeks | Primary Analysis Set: enrolled participants with baseline and follow-up (Week 48/end of treatment) bone biopsy data; participants with non-missing results. | percentage change in thickness | MEAN |
| SECONDARY | Percent Change From Baseline in OS/BS at Week 48 | Baseline, 48 weeks | Primary Analysis Set: enrolled participants with baseline and follow-up (Week 48/end of treatment) bone biopsy data; participants with non-missing results. | percent change of bone surface covered | MEAN |
| SECONDARY | Percent Change From Baseline in MLt at Week 48 | Baseline, 48 weeks | Primary Analysis Set: enrolled participants with baseline and follow-up (Week 48/end of treatment) bone biopsy data who had non-missing results. | percent change in average time interval | MEAN |
| SECONDARY | Change From Baseline in MAR at Week 48 | Baseline, 48 weeks | Primary Analysis Set: enrolled participants with baseline and follow-up (Week 48/end of treatment) bone biopsy data who had non-missing results. | µm/day | MEAN |
| SECONDARY | Change From Baseline in MS/BS at Week 48 | Baseline, 48 weeks | Primary Analysis Set: enrolled participants with baseline and follow-up (Week 48/end of treatment) bone biopsy data who had non-missing data. | percent of mineralizing surface | MEAN |
| SECONDARY | Change From Baseline in BFR/BS at Week 48 | Baseline, 48 weeks | Primary Analysis Set: enrolled participants with baseline and follow-up (Week 48/end of treatment) bone biopsy data; participants with non-missing results. | µm^3/µm^2/year | MEAN |
| SECONDARY | Change From Baseline in BFR/OS at Week 48 | Baseline, 48 weeks | Primary Analysis Set: enrolled participants with baseline and follow-up (Week 48/end of treatment) bone biopsy data; participants with non-missing results. | µm^3/µm^2/year | MEAN |
| SECONDARY | Change From Baseline in BFR/BV at Week 48 | Baseline, 48 weeks | Primary Analysis Set: enrolled participants with baseline and follow-up (Week 48/end of treatment) bone biopsy data; participants with non-missing results. | percentage of bone turnover/year | MEAN |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 outcomesResults by group98
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline in OV/BV at Week 48 | Open-Label Burosumab Q4W | -54.18 | Standard Deviation 20.211 | percentage change of unmineralized bone | |
Percentage of Participants Achieving Mean Serum Phosphorus Levels Above the Lower Limit of Normal (LLN) at the Mid-Point of the Dose Interval, as Averaged Across Dose Cycles Between Baseline and Week 24 | Open-Label Burosumab Q4W | 92.9 | 95% Confidence Interval 68.5 to 98.7 | percentage of participants | |
| Percent Change From Baseline in O.Th at Week 48 | Open-Label Burosumab Q4W | -32.21 | Standard Deviation 11.966 | percentage change in thickness | |
| Percent Change From Baseline in OS/BS at Week 48 | Open-Label Burosumab Q4W | -26.00 | Standard Deviation 15.012 | percent change of bone surface covered | |
| Percent Change From Baseline in MLt at Week 48 | Open-Label Burosumab Q4W | -52.24 | Standard Deviation 58.487 | percent change in average time interval | |
| Change From Baseline in MAR at Week 48 | Open-Label Burosumab Q4W | 0.04 | Standard Deviation 0.506 | µm/day | |
| Change From Baseline in MS/BS at Week 48 | Open-Label Burosumab Q4W | 1.32 | Standard Deviation 4.365 | percent of mineralizing surface | |
| Change From Baseline in BFR/BS at Week 48 | Open-Label Burosumab Q4W | -4.90 | Standard Deviation 27.356 | µm^3/µm^2/year | |
| Change From Baseline in BFR/OS at Week 48 | Open-Label Burosumab Q4W | -1557.25 | Standard Deviation 3139.075 | µm^3/µm^2/year | |
| Change From Baseline in BFR/BV at Week 48 | Open-Label Burosumab Q4W | -13.50 | Standard Deviation 32.904 | percentage of bone turnover/year |
1 to 10 of 98Source ClinicalTrials.gov
See all 98 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Open-Label Period (Week 0 to Week 48) | STARTED | Open-Label Burosumab Q4W | 14 | |
| Open-Label Period (Week 0 to Week 48) | COMPLETED | Open-Label Burosumab Q4W | 13 | |
| Open-Label Period (Week 0 to Week 48) | NOT COMPLETED | Open-Label Burosumab Q4W | 1 | |
| Treatment Extension Period I | STARTED | Open-Label Burosumab Q4W | 13 | |
| Treatment Extension Period I | COMPLETED | Open-Label Burosumab Q4W | 13 | |
| Treatment Extension Period I | NOT COMPLETED | Open-Label Burosumab Q4W | 0 | |
| Treatment Extension Period II | STARTED | Open-Label Burosumab Q4W | 8 | |
| Treatment Extension Period II | COMPLETED | Open-Label Burosumab Q4W | 8 | |
| Treatment Extension Period II | NOT COMPLETED | Open-Label Burosumab Q4W | 0 |
Source ClinicalTrials.gov
Adverse events161
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 | Bradycardia | Cardiac disorders | Open-Label Burosumab Q4W | 1 | 14 | |
| other | Pericarditis | Cardiac disorders | Open-Label Burosumab Q4W | 1 | 14 | |
| other | Hypoacusis | Ear and labyrinth disorders | Open-Label Burosumab Q4W | 1 | 14 | |
| other | Abdominal Discomfort | Gastrointestinal disorders | Open-Label Burosumab Q4W | 2 | 14 | |
| other | Abdominal Distension | Gastrointestinal disorders | Open-Label Burosumab Q4W | 1 | 14 | |
| other | Abdominal Pain | Gastrointestinal disorders | Open-Label Burosumab Q4W | 3 | 14 | |
| other | Abdominal Pain Upper | Gastrointestinal disorders | Open-Label Burosumab Q4W | 3 | 14 | |
| other | Constipation | Gastrointestinal disorders | Open-Label Burosumab Q4W | 3 | 14 | |
| other | Diarrhoea | Gastrointestinal disorders | Open-Label Burosumab Q4W | 2 | 14 | |
| other | Dyspepsia | Gastrointestinal disorders | Open-Label Burosumab Q4W | 1 | 14 |
1 to 10 of 161Source ClinicalTrials.gov
See all 161 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Open-Label Burosumab Q4W | 0 | 14 |
| Total, other adverse events | Open-Label Burosumab Q4W | 14 | 14 |
| Total, serious adverse events | Open-Label Burosumab Q4W | 4 | 14 |
Source ClinicalTrials.gov
Papers2
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/NCT02537431
GET https://conductscience.org/api/trials/v1/NCT02537431/registered?page=2