Osteoporosis SecondaryPhase 2RIGIDNCT06421597
Identifying Individuals at Risk of Glucocorticoid-Induced Impairment of Bone Disease
A Phase 2 study testing Prednisolone in people with Osteoporosis Secondary, run by Odense University Hospital at 2 sites in Denmark.
Trial summary
Previous studies have shown that there is a large inter-individual variability in the degree of bone loss during glucocorticoid treatment, and while some patients experience extensive bone loss other patients\' bone mass remains stable. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis Secondary
- What is being tested?
- Prednisolone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 2 sitesDenmark
- Study dates
- 4 Nov 2024to 1 Apr 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women aged 18-50 years.
Who cannot join
- Uncontrolled thyrotoxicosis
- Chronic kidney disease (eGFR <30)
- Known Cushing's syndrome
- Previous gastric bypass and/or known ongoing malabsorption
- Severe covid-19 in the last 3 month (defined as needing dexamethasone treatment)
- Use of oral or inhaled glucocorticoids within the past year
Show all 13Show fewer
- Menopause (defined as 1 year without menstrual bleeding)
- Pregnancy (defined as elevated HCG)
- Ongoing infection
- Allergy to prednisolone or one of the excipients
- Systematic fungal infections
- 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
- Not able to provide informed consent (e.g., dementia, not able to understand Danish).
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Hospital of South West Jutland
Esbjerg, 6700
Odense University Hospital
Odense C, 5000
About this study
Previous studies have shown that there is a large inter-individual variability in the degree of bone loss during glucocorticoid treatment, and while some patients experience extensive bone loss other patients\' bone mass remains stable. The aim of the study is to find a biomarker that can be used to identify individuals at risk of glucocorticoid-induced bone loss. The study will include 36 healthy volunteers, that will be randomized to receive either glucocorticoid treatment or placebo. During the study blood samples, bone marrow samples, bone tissue samples, and adipose tissue samples are taken and an oral glucose tolerance test is performed.
- Conditions
- Osteoporosis Secondary
- Being tested
- Prednisolone, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoloneDrug
prednisoline 25 mg/day for seven days
PlaceboDrug
Placebo treatment for seven days
| Study group | Role | What they receive |
|---|---|---|
| Prednisolone group | Experimental | Not described Receives: Drug: Prednisolone |
| Placebo group | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procollagen type 1 N-terminal propeptide (P1NP)
Changes in the level of the bone turnover marker P1NP in peripheral blood from baseline to day 8
Measured: Baseline to day 8
Secondary outcomes (7)
Collagen 1 cross link C-terminal telopeptide (CTX)
Changes in the level of the bone turnover marker CTX in peripheral blood from baseline to day 8 and 15
Measured: Baseline to day 8 and 15
P1NP (baseline to day 15)
Changes in the level of the bone turnover marker P1NP in peripheral blood from baseline to day 15
Measured: Baseline to day 15
Concentration of Glucocorticoid metabolites
Changes in the levels of glucocorticoid metabolites in blood from baseline to day 8
Measured: Baseline to day 8
Adipose tissue
Changes in gene expression in abdominal and gluteal subcutaneous adipose tissue from baseline to day 8
Measured: Baseline to day 8
Bone tissue
Changes in gene expression in bone tissue from baseline to day 8
Measured: Baseline to day 8
Glucose
Changes in glucose levels during a mixed meal test from baseline to day 8
Measured: Baseline to day 8
C-peptid
Changes in c-peptid levels during a mixed meal test from baseline to day 8
Measured: Baseline to day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start4 Nov 2024
- Primary completion30 Mar 2026
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporosis SecondaryStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Esbjerg Hospital - University Hospital of Southern Denmark, University of Ulm, University of Birmingham
- Responsible party
- Sponsor
- Investigators
- Anja Lisbeth Frederiksen, MD, Principal investigator, Odense University HospitalClaus Bogh Juhl, MD, Principal investigator, Esbjerg Hospital - University Hospital of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06421597
- Sponsor's protocol ID
- 2023-506949-27-00
- Other IDs
- 2023
- Acronym
- RIGID
- Status last verified
- Oct 2026
- First submitted
- 3 May 2024
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers other than collaborators. Since the data contains personal information from the study participants
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Individuals at Risk of Glucocorticoid-Induced Impairment of Bone Disease
- ClinicalTrials.gov ID
- NCT06421597
- Acronym / sponsor ID
- RIGID / 2023-506949-27-00
- Conditions
- Osteoporosis Secondary
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- Esbjerg Hospital - University Hospital of Southern Denmark, University of Ulm, University of Birmingham
- Study start
- 4 Nov 2024 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 20 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Previous studies have shown that there is a large inter-individual variability in the degree of bone loss during glucocorticoid treatment, and while some patients experience extensive bone loss other patients\' bone mass remains stable. The aim of the study is to find a biomarker that can be used to identify individuals at risk of glucocorticoid-induced bone loss. The study will include 36 healthy volunteers, that will be randomized to receive either glucocorticoid treatment or placebo. During the study blood samples, bone marrow samples, bone tissue samples, and adipose tissue samples are taken and an oral glucose tolerance test is performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prednisolone group | Experimental | Drug: Prednisolone |
| Placebo group | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Men and women aged 18-50 years.
Key exclusion criteria (13 listed)
- Uncontrolled thyrotoxicosis
- Chronic kidney disease (eGFR <30)
- Known Cushing's syndrome
- Previous gastric bypass and/or known ongoing malabsorption
- Severe covid-19 in the last 3 month (defined as needing dexamethasone treatment)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prednisoloneprednisoline 25 mg/day for seven days | Drug | Prednisolone group |
| PlaceboPlacebo treatment for seven days | Drug | Placebo group |
Primary outcome
Procollagen type 1 N-terminal propeptide (P1NP)
Time frame: Baseline to day 8
Changes in the level of the bone turnover marker P1NP in peripheral blood from baseline to day 8
7 secondary outcomes
Collagen 1 cross link C-terminal telopeptide (CTX)
Time frame: Baseline to day 8 and 15
P1NP (baseline to day 15)
Time frame: Baseline to day 15
Concentration of Glucocorticoid metabolites
Time frame: Baseline to day 8
Adipose tissue
Time frame: Baseline to day 8
Bone tissue
Time frame: Baseline to day 8
Glucose
Time frame: Baseline to day 8
C-peptid
Time frame: Baseline to day 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers other than collaborators. Since the data contains personal information from the study participants
Related trials for Osteoporosis Secondary
Not yet recruitingObservational study
Osteoporosis & Renal Disease: Research in Primary Health Care Services
Osteoporosis, Chronic Kidney Disease Mineral and Bone Disorder
RecruitingPhase 2
A Study of Romosozumab in People With Breast Cancer and Osteoporosis
Breast Cancer, Metastatic Breast Cancer (MBC)
Recruiting
RESTORE - Study of AGN1 LOEP to Prevent Secondary Hip Fractures
Fragility Fracture, Hip Fractures
RecruitingObservational study
Deep Learning for Musculoskeletal Complications in Breast Cancer
Postmastectomy Lymphedema Syndrome, Breast Cancer Surgery Pain
Not yet recruiting
The Effect of Exoskeletal-assisted Walking Combined With Transcutaneous Spinal Cord Stimulation on Bone Strength.
Secondary Osteoporosis, Sarcopenia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anja Lisbeth Frederiksen, MD principal investigator
Odense University Hospital
Claus Bogh Juhl, MD principal investigator
Esbjerg Hospital - University Hospital of Southern Denmark
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Prednisolone in people with Osteoporosis Secondary, run by Odense University Hospital at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procollagen type 1 N-terminal propeptide (P1NP) (time frame: Baseline to day 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.