Trial · NCT04146935

Examining the Effect of Burosumab on Muscle Function

NCT04146935, Phase 4, Completed, Yale University; results first posted 2023-08-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Examining the Effect of Burosumab on Muscle Function. Trials, record NCT04146935. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04146935

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Examining the Effect of Burosumab on Muscle Function
NCT number: NCT04146935
Status: Completed
Phases: Phase 4
Enrollment: 10 participants, actual
Lead sponsor: Yale University
Conditions: X-linked Hypophosphatemia
Interventions: Burosumab Injection [Crysvita]
First posted: 2019-10-31
Last updated: 2023-08-24
Results first posted: 2023-08-24

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Skeletal Muscle Adenosine Triphosphate (ATP) Synthesis Rate	2.5 months	Rates of mitochondrial phosphorylation activity were assessed in the soleus/gastrocnemius muscle complex of the right calf by 31P magnetic resonance spectroscopy saturation transfer technique (micro-mol/g/min)
Secondary	Serum Phosphate	2.5 months	measured in mg/dl
Secondary	Intracellular Phosphate Concentration in Umol/g Muscle	2.5 months	Intracellular phosphorus concentration in skeletal muscle (umol/g muscle)
Other	Six-minute Walk Test	2.5 months	functional testing outcome measured in meters
Other	Sit to Stand	2.5 months	functional testing outcome measured in the number completed in 30 seconds
Other	Timed up and go Test	2.5 months	functional testing outcome measured in seconds

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Skeletal Muscle Adenosine Triphosphate (ATP) Synthesis Rate	2.5 months	umol/g/min	LEAST_SQUARES_MEAN
SECONDARY	Serum Phosphate	2.5 months	mg/dL	LEAST_SQUARES_MEAN
SECONDARY	Intracellular Phosphate Concentration in Umol/g Muscle	2.5 months	umol/g muscle	LEAST_SQUARES_MEAN
OTHER_PRE_SPECIFIED	Six-minute Walk Test	2.5 months	meter	LEAST_SQUARES_MEAN
OTHER_PRE_SPECIFIED	Sit to Stand	2.5 months	repetitions	LEAST_SQUARES_MEAN
OTHER_PRE_SPECIFIED	Timed up and go Test	2.5 months	second	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Skeletal Muscle Adenosine Triphosphate (ATP) Synthesis Rate	Patients With XLH	9.41	95% Confidence Interval 8.7827 to 10.0333	umol/g/min
Serum Phosphate	Patients With XLH	2.85	95% Confidence Interval 2.4231 to 3.2769	mg/dL
Intracellular Phosphate Concentration in Umol/g Muscle	Patients With XLH	2.31	95% Confidence Interval 1.9654 to 2.6446	umol/g muscle
Six-minute Walk Test	Patients With XLH	440.4	95% Confidence Interval 388.06 to 492.74	meter
Sit to Stand	Patients With XLH	14.2	95% Confidence Interval 10.8312 to 17.5688	repetitions
Timed up and go Test	Patients With XLH	7.47	95% Confidence Interval 6.4473 to 8.4967	second

Source ClinicalTrials.gov

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Patients With XLH	10
Overall Study	COMPLETED	Patients With XLH	10
Overall Study	NOT COMPLETED	Patients With XLH	0

Source ClinicalTrials.gov

Adverse events1

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
serious	Partial ureteropelvic junction obstruction by staghorn calculus	Renal and urinary disorders	Patients With XLH	1	10	1

Source ClinicalTrials.gov

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Patients With XLH	0	10
Total, other adverse events	Patients With XLH	0	10
Total, serious adverse events	Patients With XLH	1	10

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
27338702	BACKGROUND

Source PubMed

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT04146935

GET https://conductscience.org/api/trials/v1/NCT04146935/registered

API reference For AI assistants