Overview
Sponsor-declared trial summary
Hypoparathyroidism
We would like to compare patients with chronic HypoPT treated with TransCon for a long-time period with chronic HypoPT patients treated with conventional treatment (activated vitamin D analogue and calcium supplements) to investigate whether the effect of HypoPT on QoL, neuropsychiatric indices, brain structures, and c…
Key facts
- Sponsor
- Region Midtjylland
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hormonal diseases [C19]
- Decision date (initial)
- 2026-04-20
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- Yes
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy
We would like to compare patients with chronic HypoPT treated with TransCon for a long-time period with chronic HypoPT patients treated with conventional treatment (activated vitamin D analogue and calcium supplements) to investigate whether the effect of HypoPT on QoL, neuropsychiatric indices, brain structures, and capillary blood flow are reversed with PTH treatment.
We will apply our contrast-enhanced MRI based method to examine whether differences in brain structure and capillary dysfunction depends on the treatment used.
Conditions and MedDRA coding
Hypoparathyroidism
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Male or female with age between 18 and 80 years.
- A low endogenous PTH production is verified by low plasma levels of intact PTH, necessitating treatment with 1-αhydroxylated vitamin D analogs.
- Stable P-calcium levels 1 month prior to inclusion
- Stable thyroid function as measured by thyroid stimulating hormone (TSH)
- Speaks and reads Danish
Exclusion criteria 11
- Reduced kidney function (eGFR < 30 mL/min/1.73m2).
- Unwillingness to participate
- Uncontrolled diabetes type 1 or 2
- Uncontrolled hypertension
- Clinical suspicion of major depression (also if treated)
- Clinical suspicion of ongoing alcohol abuse (or alcohol-related dementia)
- Other organic or psychiatric cause the patients’ symptoms
- Contraindications to contrast-enhanced MRI.
- Metal implants close to the head, which will interfere with the MRI or pacemaker. The patients will complete a metal scheme
- Claustrophobia
- Pregnancy
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Difference in microvascular hemodynamic between PTH- and conventionally treated patients with chronic HypoPT
Secondary endpoints 3
- Correlation between cognitive impairment measured by neuropsychological assessment and capillary transit time heterogeneity, cortical blood volume and hemodynamic parameters.
- Status of cognitive function in PTH treated compared to conventional treated controls
- Difference in groups in size of structures in the brain.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Yorvipath 168 micrograms/0.56 mL solution for injection in pre‑filled pen
PRD10961896 · Product
- Active substance
- Palopegteriparatide
- Substance synonyms
- ACP-014, Poly(oxy-1,2-ethanediyl), alpha-hydro-omega-methoxy, ether with N-[[[2-[[6-[[1-[3-[[3-(2,3-dihydroxypropoxy)propyl]amino]-3-oxopropyl]-2,5-dioxo-3-pyrrolidinyl]thio]hexyl]amino]ethyl]amino]carbonyl]-2-methylalanyl-teriparatide (2:1), TERIPARATIDE CONJUGATED TO A MULTI-ARM POLYETHYLENE GLYCOL CARRIER MOLECULE THROUGH A CLEAVABLE LINKER, TRANSCON PTH
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 420 µg microgram(s)
- Max total dose
- 999 µg microgram(s)
- Max treatment duration
- 999 Month(s)
- Authorisation status
- Authorised
- ATC code
- H05AA05 — -
- Marketing authorisation
- EU/1/23/1766/001
- MA holder
- ASCENDIS PHARMA BONE DISEASES A/S
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/20/2350
- Modified vs. Marketing Authorisation
- No
Comparator 1
Alfacalcidol Stada 1 micrograme capsule moi
PRD10562012 · Product
- Active substance
- Alfacalcidol
- Pharmaceutical form
- CAPSULE, SOFT
- Route of administration
- ORAL
- Max daily dose
- 10 µg microgram(s)
- Max total dose
- 10 µg microgram(s)
- Max treatment duration
- 999 Month(s)
- Authorisation status
- Authorised
- ATC code
- A11CC03 — ALFACALCIDOL
- Marketing authorisation
- 15039/2023/07
- MA holder
- STADA M&D S.R.L.
- MA country
- Romania
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Region Midtjylland
- Sponsor organisation
- Region Midtjylland
- Address
- Palle Juul-Jensens Boulevard 99
- City
- Aarhus N
- Postcode
- 8200
- Country
- Denmark
Scientific contact point
- Organisation
- Region Midtjylland
- Contact name
- tanja tvistholm sikjær
Public contact point
- Organisation
- Region Midtjylland
- Contact name
- tanja tvistholm sikjær
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| GCP enhederne ORL-000014084
|
AARHUS N, Denmark | On site monitoring |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Authorised, recruitment pending | 40 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 11 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Protocol version 1 | 1.3 |
| Recruitment arrangements (for publication) | 9 screeningssprgsmal version 1_0 | 1 |
| Recruitment arrangements (for publication) | Recruitment arrangements version 1 | 1.2 |
| Recruitment arrangements (for publication) | Recruitment material letter version 1 | 1.1 |
| Subject information and informed consent form (for publication) | Dine rettigheder som forsgsperson i forsg med medicin | 1 |
| Subject information and informed consent form (for publication) | L_SIS and ICF version 1_2 | 1.3 |
| Subject information and informed consent form (for publication) | Tillg til samtykkeblanket - Retten til ikke-viden | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Alfacalcidol | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | yorvipath-epar-product-information | 1 |
| Synopsis of the protocol (for publication) | D1 protocol synopsis danish version1 | 1 |
| Synopsis of the protocol (for publication) | D1 protocol synopsis engelsk version 1 | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-12-22 | Denmark | Acceptable 2026-04-16
|
2026-04-20 |