Trial · NCT01652573

Calcitonin for Treating X-linked Hypophosphatemia

NCT01652573, Not applicable, Completed, Yale University; results first posted 2017-05-31

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Calcitonin for Treating X-linked Hypophosphatemia. Trials, record NCT01652573. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01652573

On this page

Trial

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

Title: Calcitonin for Treating X-linked Hypophosphatemia
NCT number: NCT01652573
Status: Completed
Phases: Not applicable
Enrollment: 21 participants, actual
Lead sponsor: Yale University
Conditions: Hypophosphatemic Rickets, X Linked Dominant
Interventions: nasal salmon calcitonin, Saline Nasal Spray Placebo
First posted: 2012-07-30
Last updated: 2017-05-31
Results first posted: 2017-05-31
Limitations and caveats: It is possible that there is a threshold serum concentration of drug required to suppress FGF23 levels and our sample size was small.

Source ClinicalTrials.gov

Registered outcomes18

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

List	Outcome	Time frame	Description
Primary	Area Under the Curve for FGF23	Time 0	FGF23 will be measured 0 to 24 hours post dose during a 24 hour admission and AUC calculated.
Primary	Area Under the Curve for FGF23	3 months	FGF23 will be measured 0 to 24 hours post dose during a 24 hour admission at 3 months and AUC calculated and compared to baseline.
Secondary	Area Under the Curve for TmP/GFR	Time 0	Serum phosphate will be measured 0 to 24 hours postdose during a 24 hr admission, AUC calculated, and fasting Tmp/GFR calculated.
Secondary	Area Under the Curve for 1,25(OH)2vitamin D	Time 0	Serum 1,25(OH)2vitamin D will be measured 0 to 24 hours post dose during a 24 hr admission and AUC calculated.
Secondary	Number of Patients With Nasal Congestion at Baseline	Time 0	This symptom will be assessed at baseline
Secondary	Area Under the Curve for TmP/GFR	Time 3 months	TmP/GFR will be measured 0 to 24 hours postdose during a 24 hr admission at 3 months and AUC calculated and compared to baseline.
Secondary	Area Under the Curve for 1,25(OH)2vitamin D	Time 3 months	Serum 1,25(OH)2vitamin D will be measured 0 to 24 hours post dose during a 24 hr admission and AUC calculated and results will be compared to baseline values.
Secondary	Number of Participants With Nasal Congestion at 1 Month	Time 1 month	This symptom will be assessed.
Secondary	Number of Participants With Nasal Congestion at 2 Months	Time 2 months	This symptom will be assessed.
Secondary	Number of Participants With Nasal Congestion at 3 Months	Time 3 months	This symptom will be assessed.

1 to 10 of 18Source ClinicalTrials.gov

See all 18 registered outcomes

Outcomes18

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

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Area Under the Curve for FGF23	Time 0	pg/ml*hr	LEAST_SQUARES_MEAN
PRIMARY	Area Under the Curve for FGF23	3 months	pg/ml*hr	LEAST_SQUARES_MEAN
SECONDARY	Area Under the Curve for TmP/GFR	Time 0	mg/100 ml GF*hr	LEAST_SQUARES_MEAN
SECONDARY	Area Under the Curve for 1,25(OH)2vitamin D	Time 0	ng/ml*hr	LEAST_SQUARES_MEAN
SECONDARY	Number of Patients With Nasal Congestion at Baseline	Time 0	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Area Under the Curve for TmP/GFR	Time 3 months	mg/100 ml GF*hr	LEAST_SQUARES_MEAN
SECONDARY	Area Under the Curve for 1,25(OH)2vitamin D	Time 3 months	ng/ml*hr	LEAST_SQUARES_MEAN
SECONDARY	Number of Participants With Nasal Congestion at 1 Month	Time 1 month	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Nasal Congestion at 2 Months	Time 2 months	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Nasal Congestion at 3 Months	Time 3 months	Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 18Source ClinicalTrials.gov

See all 18 outcomes

Results by group36

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

Outcome	Group	Value	Spread	Units
Area Under the Curve for FGF23	Nasal Calictonin	3172.34	95% Confidence Interval 3068.7 to 3332.68	pg/ml*hr
Area Under the Curve for FGF23	Saline Nasal Spray	3215.34	95% Confidence Interval 3107.17 to 3374.97	pg/ml*hr
Area Under the Curve for FGF23	Nasal Calictonin	2698.38	95% Confidence Interval 2623.07 to 2830.39	pg/ml*hr
Area Under the Curve for FGF23	Saline Nasal Spray	2994.26	95% Confidence Interval 2907.61 to 3134.26	pg/ml*hr
Area Under the Curve for TmP/GFR	Nasal Calictonin	30.70	95% Confidence Interval 29.5 to 32.27	mg/100 ml GF*hr
Area Under the Curve for TmP/GFR	Saline Nasal Spray	29.97	95% Confidence Interval 28.78 to 31.49	mg/100 ml GF*hr
Area Under the Curve for 1,25(OH)2vitamin D	Nasal Calictonin	904.06	95% Confidence Interval 862.86 to 961.90	ng/ml*hr
Area Under the Curve for 1,25(OH)2vitamin D	Saline Nasal Spray	838.58	95% Confidence Interval 799.18 to 892.99	ng/ml*hr
Number of Patients With Nasal Congestion at Baseline	Nasal Calictonin	0		Participants
Number of Patients With Nasal Congestion at Baseline	Saline Nasal Spray	0		Participants

1 to 10 of 36Source ClinicalTrials.gov

See all 36 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Nasal Calictonin	10
Overall Study	STARTED	Saline Nasal Spray	11
Overall Study	COMPLETED	Nasal Calictonin	10
Overall Study	COMPLETED	Saline Nasal Spray	10
Overall Study	NOT COMPLETED	Nasal Calictonin	0
Overall Study	NOT COMPLETED	Saline Nasal Spray	1

Source ClinicalTrials.gov

Adverse events6

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	Dermatologic	Skin and subcutaneous tissue disorders	Nasal Calictonin	1	10	1
other	Dermatologic	Skin and subcutaneous tissue disorders	Saline Nasal Spray	2	11	2
other	musculoskeletal events	Musculoskeletal and connective tissue disorders	Nasal Calictonin	1	10	1
other	musculoskeletal events	Musculoskeletal and connective tissue disorders	Saline Nasal Spray	2	11	2
other	Respiratory events	Respiratory, thoracic and mediastinal disorders	Nasal Calictonin	2	10	2
other	Respiratory events	Respiratory, thoracic and mediastinal disorders	Saline Nasal Spray	2	11	2

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Nasal Calictonin	0	10
Total, all-cause mortality	Saline Nasal Spray	0	11
Total, other adverse events	Nasal Calictonin	2	10
Total, other adverse events	Saline Nasal Spray	2	11
Total, serious adverse events	Nasal Calictonin	0	10
Total, serious adverse events	Saline Nasal Spray	0	11

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

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.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R21AR061818	Calcitonin for Treating X-linked Hypophosphatemia	INSOGNA, KARL LEONARD	YALE UNIVERSITY	NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES	2011 to 2012

Source NIH RePORTER

Trial comparisons14

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Nasal Calictonin vs Saline Nasal Spray: Number of Participants With Nasal Ulceration at 1 Month	Trial comparisons
Nasal Calictonin vs Saline Nasal Spray: Number of Participants With Nasal Ulceration at 2 Months	Trial comparisons
Nasal Calictonin vs Saline Nasal Spray: Number of Participants With Nasal Congestion at 1 Month	Trial comparisons
Nasal Calictonin vs Saline Nasal Spray: Number of Participants With Allergic Reactions at 1 Month	Trial comparisons
Nasal Calictonin vs Saline Nasal Spray: Number of Patients With Nasal Congestion at Baseline	Trial comparisons
Nasal Calictonin vs Saline Nasal Spray: Number of Participants With Allergic Reactions at Baseline	Trial comparisons
Nasal Calictonin vs Saline Nasal Spray: Number of Participants With Nasal Congestion at 2 Months	Trial comparisons
Nasal Calictonin vs Saline Nasal Spray: Number of Participants With Nasal Ulcerations at 3 Months	Trial comparisons
Nasal Calictonin vs Saline Nasal Spray: Number of Participants With Allergic Reactions at 3 Months	Trial comparisons
Nasal Calictonin vs Saline Nasal Spray: Number of Participants With Allergic Reactions at 2 Months	Trial comparisons

1 to 10 of 14

See all 14 trial comparisons

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/NCT01652573

GET https://conductscience.org/api/trials/v1/NCT01652573/results?page=2

API reference For AI assistants