Overview
Sponsor-declared trial summary
Primary hyperparathyroidism
Our overall aim is a physiological investigation of the effect of bisphosphonate treatment versus placebo at time of parathyroidectomy (PTX) in patients with primary hyperparathyroidism (PHPT) on bone, kidney and the cardiovascular system one-year post-surgery.
Key facts
- Sponsor
- Region Midtjylland
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05]
- Trial duration
- 2 Mar 2025 → ongoing
- Decision date (initial)
- 2025-01-02
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-520073-13-00
- EudraCT number
- 2023-000007-39
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic
Our overall aim is a physiological investigation of the effect of bisphosphonate treatment versus placebo at time of parathyroidectomy (PTX) in patients with primary hyperparathyroidism (PHPT) on
bone, kidney and the cardiovascular system one-year post-surgery.
Conditions and MedDRA coding
Primary hyperparathyroidism
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Females or males > 40 years
- A diagnosis of hyperparathyroid hypercalcemia due to sporadic PHPT referred to PTX
- aBMD T-score or Z-score ≤ -1 at total hip, femoral neck, distal forearm, or lumbar spine
- 25-hydroxyvitamin D ≥ 50 nmol/l prior to randomization
- Willingness to undergo PTX
Exclusion criteria 6
- Known or suspected familial ethology (e.g., MEN1 or 2)
- Estimated glomerular filtration rate < 35 ml/min
- Known allergy to bisphosphonates
- Planned or recent (within the last 3 months) major dental procedures (e.g., jaw surgery or tooth extraction)
- Chronic or acute disorders (e.g., rheumatoid arthritis, inflammatory bowel disease, cancer) or prior medications (e.g., lithium, glucocorticoids within the last year, antiresorptive or bone anabolic treatment within the last 3 years) known to affect bone metabolism
- Current or planned pregnancy in females
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Effects of ZOL vs. placebo at time of parathyroidectomy on aBMD at lumbar spine, one year after PTX.
Secondary endpoints 7
- Effects on aBMD at distal forearm, femoral neck, and total hip
- Effects on microarchitecture measured by high-resolution peripheral computed tomography (HRpQCT)
- Effects on biochemical bone turnover markers (BTM).
- Effects on vBMD at the hip and lumbar spine.
- Effects on CACS.
- Effects on PWV.
- Effects on renal calcifications and urinary analytes.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Zoledronic Acid Oresund Pharma 4 mg/100 ml infusionsvätska, lösning
PRD8924813 · Product
- Active substance
- Zoledronic Acid
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSIÓN INTRAVENOSA
- Max daily dose
- 4 mg milligram(s)
- Max total dose
- 4 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- M05BA08 — ZOLEDRONIC ACID
- Marketing authorisation
- 52486
- MA holder
- ORESUND PHARMA APS
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
SUB12581MIG · Substance
- Active substance
- Sodium Chloride
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- IV INFUSION
- Max daily dose
- 100 ml millilitre(s)
- Max total dose
- 100 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- 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
- Anne Louise Vandsø Svenningsen
Public contact point
- Organisation
- Region Midtjylland
- Contact name
- Anne Louise Vandsø Svenningsen
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Aarhus Universitet ORG-100028380
|
Aarhus N, Denmark | On site monitoring |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 140 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2025-03-02 | 2025-03-14 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 9 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol EU CT 2024-520073-13-00 | 3.1 |
| Protocol (for publication) | D4_Patient facing documents questionnaire | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICT adults consent form | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICT adults participants information | 3.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material information pamphlet | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information pamphlet rettigheder forsg V1 12Jan2026 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC zoledronic acid | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC zoledronic acid | 1 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-05 | Denmark | Acceptable 2024-12-19
|
2025-01-02 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-05-26 | Denmark | Acceptable 2025-06-02
|
2025-06-03 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-12-10 | Denmark | Acceptable 2026-01-26
|
2026-02-02 |