Identifying Individuals at Risk of Glucocorticoid-Induced Impairment of Bone Disease (RIGID

2023-506949-27-00 Therapeutic exploratory (Phase II) Ended

Start 14 Oct 2024 · End 30 Mar 2026 · Status Ended · 1 EU/EEA countries · 2 sites

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)
Status Ended
Participants planned 36
Countries 1
Sites 2

Secondary Osteoporosis

The main objective of the study is to detect a biomarker(s) that identifies individuals at risk of Glucocorticoid-Induced Impairment of Bone Disease

Key facts

Sponsor
Odense University Hospital
Participant type
Healthy volunteers
Age range
18-64 years
Gender
Male and Female
Therapeutic area
Diseases [C] - Hormonal diseases [C19]
Trial duration
14 Oct 2024 → 30 Mar 2026
Decision date (initial)
2024-03-27
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No
Funding sources
Danmarks Frie Forskningsfond

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacodynamic

The main objective of the study is to detect a biomarker(s) that identifies individuals at risk of Glucocorticoid-Induced Impairment of Bone Disease

Secondary objectives 1

  1. The secondary objective is to study the mechanism behind Glucocorticoid-Induced Impairment of Bone Disease

Conditions and MedDRA coding

Secondary Osteoporosis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

  1. Men and women aged 18-50 years

Exclusion criteria 13

  1. Uncontrolled thyrotoxicosis
  2. Chronic kidney disease (eGFR <30)
  3. Known Cushing’s syndrome
  4. Previous gastric bypass and/or known ongoing malabsorption
  5. Severe covid-19 in the last 3 month (defined as needing dexamethasone treatment)
  6. Use of oral or inhaled GCs within the past year
  7. Menopause (defined as 1 year without menstrual bleeding)
  8. Pregnancy (defined as elevated HCG)
  9. Ongoing infection
  10. Allergy to prednisolone or one of the excipients
  11. Systematic fungal infections
  12. Vaccination with living or weaken viral or bacterial vaccines in patient who or immunocompromised. In these cases, prednisolone treatment should not be administered two weeks before and after vaccination.
  13. Not able to provide informed consent (e.g., dementia, not able to understand Danish). At the information meeting the investigator will make an individual assessment to evaluate whether a potential study participants understand the information.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Changes in the level of P1NP in peripheral blood from baseline to day 7

Secondary endpoints 6

  1. Changes in the level of CTX in peripheral blood from baseline to day 7 and 14
  2. Changes in the level of P1NP in peripheral blood from baseline to day 14
  3. Changes in GC metabolites in blood from baseline to day 7 (e.g., prednisone levels, and the prednisolone/prednisone ratio)
  4. Changes in gene expression in abdominal and gluteal subcutaneous adipose tissue from baseline to day 7 (e.g., adiponectin or visfatin)
  5. Changes in gene expression in bone tissue from baseline to day 7 (e.g., RUNX2 or osteocalcin)
  6. Changes in insulin secretion and sensitivity from baseline to day 7

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Prednisolone 25mg Tablets

PRD10163471 · Product

Active substance
Prednisolone
Pharmaceutical form
TABLET
Route of administration
ORAL
Max daily dose
25 mg milligram(s)
Max total dose
175 mg milligram(s)
Max treatment duration
1 Week(s)
Authorisation status
Authorised
ATC code
H02AB06 — PREDNISOLONE
Marketing authorisation
PL 17780/0309
MA holder
ZENTIVA PHARMA UK LIMITED
MA country
XI
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Placebo 1

Placebo

SUB21402 · Substance

Active substance
Placebo
Pharmaceutical form
TABLET
Route of administration
ORAL
Max daily dose
25 mg milligram(s)
Max total dose
175 mg milligram(s)
Max treatment duration
1 Week(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

Odense University Hospital

51 Total trials 30 Recruiting 11 Ended
Academic / Non-commercial
Sponsor organisation
Odense University Hospital
Address
J B Winsloews Vej 4
City
Odense C
Postcode
5000
Country
Denmark

Scientific contact point

Organisation
Odense University Hospital
Contact name
Catharina Vind Nielsen

Public contact point

Organisation
Odense University Hospital
Contact name
Catharina Vind Nielsen

Third parties 3

OrganisationCity, countryDuties
The University Of Birmingham
ORG-100020045
 Birmingham, United Kingdom Laboratory analysis
Universitaetsklinikum Ulm AöR
ORG-100006370
 Ulm, Germany Laboratory analysis
Odense University Hospital
ORG-100007716
 Odense C, Denmark On site monitoring, E-data capture, Code 8

Locations

1 EU/EEA country · 2 investigational sites

By country

CountryMS statusPlanned subjectsSites
Denmark Ended 36 2
Rest of world — 0 —

Investigational sites

Denmark

2 sites · Ended
Esbjerg Og Grindsted Sygehus
Department of Endocrinology, Finsensgade 35, 6700, Esbjerg
Odense University Hospital
Department of Genetics, J B Winsloews Vej 4, 5000, Odense C

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Denmark 2024-10-14 2026-03-30 2024-10-15 2026-03-17

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 13 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) Protocol 2023-506949-27-00 4
Recruitment arrangements (for publication) Recruitment arrangements 3
Recruitment arrangements (for publication) Recruitment material document 3
Recruitment arrangements (for publication) Recruitment material document_poster 1
Subject information and informed consent form (for publication) ICF 2
Subject information and informed consent form (for publication) ICF uden biobank 1
Subject information and informed consent form (for publication) Other subject information material - Behandlingsvejledning prednisolon 1
Subject information and informed consent form (for publication) Other subject information material - Bivirkninger til prednisolon 1
Subject information and informed consent form (for publication) Other subject information material - Dine rettigheder som forsgsperson i forsg med medicin 1
Subject information and informed consent form (for publication) Other subject information material - Tidsplan over forsgsrelaterede procedurer 3
Subject information and informed consent form (for publication) SIS 4
Summary of Product Characteristics (SmPC) (for publication) SmPC Prednisolone 2
Synopsis of the protocol (for publication) Protocol synopsis_ENG 2023-506949-27-00 3

Application history

4 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-01-22 Denmark Acceptable
2024-03-27
 2024-03-27
2 SUBSTANTIAL MODIFICATION SM-3 2024-08-15 Denmark Acceptable
2024-10-11
 2024-10-14
3 NON SUBSTANTIAL MODIFICATION NSM-1 2024-11-25 Denmark Acceptable
2024-10-11
 2024-11-25
4 SUBSTANTIAL MODIFICATION SM-4 2025-11-14 Denmark Acceptable
2025-12-05
 2025-12-05