Trial · NCT04701203

A Trial Investigating the Safety, Tolerability and Efficacy of TransCon PTH Administered Daily in Adults With Hypoparathyroidism

NCT04701203, Phase 3, Completed, Ascendis Pharma Bone Diseases A/S; results first posted 2025-02-28

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Trial Investigating the Safety, Tolerability and Efficacy of TransCon PTH Administered Daily in Adults With Hypoparathyroidism. Trials, record NCT04701203. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04701203

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Trial

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

Title: A Trial Investigating the Safety, Tolerability and Efficacy of TransCon PTH Administered Daily in Adults With Hypoparathyroidism
NCT number: NCT04701203
Status: Completed
Phases: Phase 3
Enrollment: 84 participants, actual
Lead sponsor: Ascendis Pharma Bone Diseases A/S
Conditions: Hypoparathyroidism, Endocrine System Diseases, Parathyroid Diseases
Interventions: TransCon PTH, Placebo
First posted: 2021-01-08
Last updated: 2026-07-07
Other registries' IDs: eudract:2020-003380-26
Results first posted: 2025-02-28

Source ClinicalTrials.gov

Registered outcomes6

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

List	Outcome	Time frame	Description
Primary	Efficacy - Primary Endpoint During the Blinded Period	26 weeks	The primary endpoint was a multi-component endpoint that included the percentage of participants who met the following criteria at 26 weeks of blinded treatment: 1) albumin-adjusted serum calcium measured within 4 weeks prior to and on Week 26 visit within the normal range (8.3 to 10.6 mg/dL), and 2) independence from active vitamin D within 4 weeks prior to Week 26 visit (i.e., all daily standing dose of active vitamin D equal to zero AND use of PRN ≤7 days during the 4 weeks), and 3) independence from therapeutic doses of calcium within 4 weeks prior to Week 26 visit (i.e., average daily standing dose of elemental calcium ≤600 mg AND use of PRN doses on ≤7 days during the 4 weeks), and 4) no increase in prescribed study drug within 4 weeks prior to Week 26 visit.
Secondary	Change From Baseline to Week 26 in HPES Symptom - Physical Domain Score	26 weeks	Change from baseline in Hypoparathyroidism Patient Experience Scale (HPES) Symptom - Physical Domain score, a disease-specific patient reported outcome, at 26 weeks of treatment. The measure uses a scale of 0-100 and values represent the change in scores from baseline. A decrease in HPES score denotes an improvement in hypoparathyroidism disease related physical symptoms.
Secondary	Change From Baseline to Week 26 in HPES Symptom - Cognitive Domain Score	26 weeks	Change from baseline in Hypoparathyroidism Patient Experience Scale (HPES) Symptom - Cognitive Domain score, a disease-specific patient reported outcome, at 26 weeks of treatment. The measure uses a scale of 0-100 and values represent the change in scores from baseline. A decrease in HPES score denotes an improvement in hypoparathyroidism disease related cognitive symptoms.
Secondary	Change From Baseline to Week 26 in HPES Impact - Physical Functioning Domain Score	26 weeks	Change from baseline in Hypoparathyroidism Patient Experience Scale (HPES) Impact - Physical Functioning Domain score, a disease-specific patient reported outcome, at 26 weeks of treatment. The measure uses a scale of 0-100 and values represent the change in scores from baseline. A decrease in HPES score denotes an improvement in physical functioning health-related quality of life.
Secondary	Change From Baseline to Week 26 in HPES Impact - Daily Life Domain Score	26 weeks	Change from baseline in Hypoparathyroidism Patient Experience Scale (HPES) Impact - Daily Life Domain score, a disease-specific patient reported outcome, at 26 weeks of treatment. The measure uses a scale of 0-100 and values represent the change in scores from baseline. A decrease in HPES score denotes an improvement in daily health-related quality of life.
Secondary	Change From Baseline to Week 26 in SF-36 Physical Functioning Subscale Score	26 weeks	Change from baseline in the 36-item Short Form Survey (SF-36) Physical Functioning subscale score, a generic health survey, at 26 weeks of treatment. The Physical Functioning subscale uses a range of 19-57.6 and values represent the change in scores from baseline. An increase in SF-36 score denotes an improvement in physical functioning health-related quality of life.

Source ClinicalTrials.gov

Outcomes6

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Efficacy - Primary Endpoint During the Blinded Period	26 weeks		Percentage of participants	NUMBER
SECONDARY	Change From Baseline to Week 26 in HPES Symptom - Physical Domain Score	26 weeks	The overall number of participants analyzed represents the number of subjects with both baseline and Week 26 visit values available.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline to Week 26 in HPES Symptom - Cognitive Domain Score	26 weeks	The overall number of participants analyzed represents the number of subjects with both baseline and Week 26 visit values available.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline to Week 26 in HPES Impact - Physical Functioning Domain Score	26 weeks	The overall number of participants analyzed represents the number of subjects with both baseline and Week 26 visit values available.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline to Week 26 in HPES Impact - Daily Life Domain Score	26 weeks	The overall number of participants analyzed represents the number of subjects with both baseline and Week 26 visit values available.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline to Week 26 in SF-36 Physical Functioning Subscale Score	26 weeks	The overall number of participants analyzed represents the number of subjects with both baseline and Week 26 visit values available.	units on a scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group12

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

Outcome	Group	Value	Spread	Units
Efficacy - Primary Endpoint During the Blinded Period	TransCon PTH	78.7	95% Confidence Interval 66.3 to 88.1	Percentage of participants
Efficacy - Primary Endpoint During the Blinded Period	Placebo	4.8	95% Confidence Interval 0.1 to 23.8	Percentage of participants
Change From Baseline to Week 26 in HPES Symptom - Physical Domain Score	TransCon PTH	-21.01	95% Confidence Interval -25.41 to -16.60	units on a scale
Change From Baseline to Week 26 in HPES Symptom - Physical Domain Score	Placebo	-4.81	95% Confidence Interval -15.22 to 5.59	units on a scale
Change From Baseline to Week 26 in HPES Symptom - Cognitive Domain Score	TransCon PTH	-20.49	95% Confidence Interval -25.67 to -15.31	units on a scale
Change From Baseline to Week 26 in HPES Symptom - Cognitive Domain Score	Placebo	-6.16	95% Confidence Interval -15.92 to 3.60	units on a scale
Change From Baseline to Week 26 in HPES Impact - Physical Functioning Domain Score	TransCon PTH	-18.29	95% Confidence Interval -23.59 to -12.99	units on a scale
Change From Baseline to Week 26 in HPES Impact - Physical Functioning Domain Score	Placebo	-1.01	95% Confidence Interval -12.40 to 10.38	units on a scale
Change From Baseline to Week 26 in HPES Impact - Daily Life Domain Score	TransCon PTH	-17.65	95% Confidence Interval -22.39 to -12.91	units on a scale
Change From Baseline to Week 26 in HPES Impact - Daily Life Domain Score	Placebo	-0.36	95% Confidence Interval -12.19 to 11.46	units on a scale

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow18

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

Period	Milestone	Group	Participants
Blinded Period (Weeks 0 to 26)	STARTED	Double Blind: TransCon PTH	61
Blinded Period (Weeks 0 to 26)	STARTED	Double Blind: Placebo	21
Blinded Period (Weeks 0 to 26)	STARTED	Open-Label Extension Period: TransCon PTH	0
Blinded Period (Weeks 0 to 26)	COMPLETED	Double Blind: TransCon PTH	60
Blinded Period (Weeks 0 to 26)	COMPLETED	Double Blind: Placebo	19
Blinded Period (Weeks 0 to 26)	COMPLETED	Open-Label Extension Period: TransCon PTH	0
Blinded Period (Weeks 0 to 26)	NOT COMPLETED	Double Blind: TransCon PTH	1
Blinded Period (Weeks 0 to 26)	NOT COMPLETED	Double Blind: Placebo	2
Blinded Period (Weeks 0 to 26)	NOT COMPLETED	Open-Label Extension Period: TransCon PTH	0
Open-Label Period (Weeks 26 to 182)	STARTED	Double Blind: TransCon PTH	0

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events204

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
other	Blood thyroid stimulating hormone decreased	Investigations	Double Blind: TransCon PTH	3	61
other	Blood thyroid stimulating hormone decreased	Investigations	Double Blind: Placebo	3	21
other	Blood thyroid stimulating hormone decreased	Investigations	Total TransCon PTH Period	11	80
other	Hypertension	Vascular disorders	Double Blind: TransCon PTH	3	61
other	Hypertension	Vascular disorders	Double Blind: Placebo	3	21
other	Hypertension	Vascular disorders	Total TransCon PTH Period	12	80
other	Headache	Nervous system disorders	Double Blind: TransCon PTH	13	61
other	Headache	Nervous system disorders	Double Blind: Placebo	2	21
other	Headache	Nervous system disorders	Total TransCon PTH Period	19	80
other	Paraesthesia	Nervous system disorders	Double Blind: TransCon PTH	12	61

1 to 10 of 204Source ClinicalTrials.gov

See all 204 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Double Blind: TransCon PTH	1	61
Total, all-cause mortality	Double Blind: Placebo	0	21
Total, all-cause mortality	Total TransCon PTH Period	1	80
Total, other adverse events	Double Blind: TransCon PTH	50	61
Total, other adverse events	Double Blind: Placebo	20	21
Total, other adverse events	Total TransCon PTH Period	72	80
Total, serious adverse events	Double Blind: TransCon PTH	5	61
Total, serious adverse events	Double Blind: Placebo	2	21
Total, serious adverse events	Total TransCon PTH Period	20	80

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
38691316	DERIVED	PubMed
39136801	DERIVED	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/NCT04701203

GET https://conductscience.org/api/trials/v1/NCT04701203/events?page=2

API reference For AI assistants