OsteoporosisBOOGIENCT06395883
Dynamics in Bone Turnover Markers During and After Short-term Glucocorticoid Treatment in Patients With an Inflammatory Joint Disease
An observational study of Osteoporosis and Osteoporosis, Steroid Induced, run by Diakonhjemmet Hospital at 2 sites in Norway.
Trial summary
Bone turnover markers (BTMs) are recommended as an important tool in follow-up of osteoporosis treatment. However, there is a lack of knowledge in the reliability of BTMs during and after glucocorticoid treatment. Read more about this study
- Who is it for?
- Ages 25 to 90 years
- Conditions the study is for
- Osteoporosis, Osteoporosis, Steroid Induced, Inflammatory Rheumatism
- What is being tested?
- Glucocorticoid Effect
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 160 participants
- Where
- 2 sitesNorway
- Study dates
- 1 Jan 2025to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 25 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a diagnosis of rheumatoid arthritis or spondyloarthritis or psoriatic arthritis
Who may be able to join
- diagnosis of inflammatory rheumatic joint disease
- indication of disease modifying treatment initiation with or without glucocorticoids OR
- stable DMARD treatment with parenteral glucocorticoid injection
Who cannot join
- known osteoporosis or osteoporosis treatment
- women during the transitory phase
- oestrogen treatment
- any fracture within the last year
- chronic glucocorticoid treatment
- glucocorticoid treatment within the last year prior to inclusion
- active cancer
- kidney failure
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Norway2 sites, 2 recruiting
- Recruiting
Vestre Viken HF, Drammen
Drammen, 3024
- Recruiting
Diakonhjemmet hospital
Oslo, 0319
About this study
Official title: Dynamics in Bone Turnover Markers During and After Short-term Glucocorticoid Treatment in Patients With an Inflammatory Joint Disease - the BOOGIE Study
Bone turnover markers (BTMs) are recommended as an important tool in follow-up of osteoporosis treatment. However, there is a lack of knowledge in the reliability of BTMs during and after glucocorticoid treatment. Glucocorticoids suppresses BTMs during treatment with at least 30% and, moreover, glucocorticoids increase the risk of fractures. Patients with an inflammatory joint disease are at increased risk of osteoporosis, and disease flares are often treated with glucocorticoids, which in turn can lead to loss in reliability of the BTMs in patients who also are on osteoporosis treatment.
There is a need of more knowledge on BTM changes during and after glucocorticoid treatment for optimized patientcare, reduced risk of side effects and reduced health economic costs.
- Being tested
- Glucocorticoid Effect
- Keywords
- Bone turnover, Bone turnover markers, Glucocorticoids
- Medical subject headings
- Osteoporosis, Rheumatic Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucocorticoid EffectDrug
Patients with or without glucocorticoid treatment will be observed regarding the level of bone turnover markers (P1NP and CTX1) every 4 weeks til 6 months after the last glucocorticoid dose.
| Study group | Role | What they receive |
|---|---|---|
| RApre | Patients with a new diagnosis of rheumatoid arthritis and indication for initiating DMARD treatment with a bridging of oral glucocorticoid treatment. Women should be premenopausal and men younger than 50 years. Receives: Drug: Glucocorticoid Effect | |
| RApost | Patients with a new diagnosis of rheumatoid arthritis and indication for initiating DMARD treatment with a bridging of oral glucocorticoid treatment. Women should be postmenopausal and men older than 50 years. Receives: Drug: Glucocorticoid Effect | |
| SpA | Patients with a new diagnosis of spondyloarthritis and indication of DMARD treatment without glucocorticoid treatment. Women should be premenopausal and men younger than 50 years. | |
| PsA | Patients with a new diagnosis of psoriatic arthritis and indication of DMARD treatment without glucocorticoid treatment. Women should be premenopausal and men younger than 50 years. | |
| IA | Patients with an inflammatory joint disease on stable DMARD treatment weith indication of intraarticular glucocorticoid injection. Women should be premenopausal and men younger than 50 years. Receives: Drug: Glucocorticoid Effect | |
| IM | Patients with an inflammatory joint disease on stable DMARD treatment weith indication of intramuscular glucocorticoid injection. Women should be premenopausal and men younger than 50 years. Receives: Drug: Glucocorticoid Effect |
What is being measured
The primary outcome is the main question the study is designed to answer.
P1NP level 3 months after glucocorticoid termination
P1NP in a blood sample
Measured: september 2024 til december 2025
Secondary outcomes (3)
P1NP level 6 months after glucocorticoid termination
P1NP in a blood sample
Measured: september 2024 til december 2025
CTX1 level 3 and 6 months after glucocorticoid termination
CTX1 in a blood sample
Measured: september 2024 til december 2025
P1NP and CTX1 dynamic until 6 months after treatment of inflammation without glucocorticoids
P1NP and CTX1 in a blood sample
Measured: september 2024 til december 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start1 Jan 2025
- Primary completionOct 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diakonhjemmet Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Vestre Viken Hospital Trust, Hormone Laboratory, Aker University Hospital, Oslo, Norway
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06395883
- Sponsor's protocol ID
- DS-00846
- Acronym
- BOOGIE
- Status last verified
- Aug 2026
- First submitted
- 29 Apr 2024
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamics in Bone Turnover Markers During and After Short-term Glucocorticoid Treatment in Patients With an Inflammatory Joint Disease - the BOOGIE Study
- ClinicalTrials.gov ID
- NCT06395883
- Acronym / sponsor ID
- BOOGIE / DS-00846
- Keywords
- Bone turnover, Bone turnover markers, Glucocorticoids
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Diakonhjemmet HospitalUniversity, hospital or other
- Collaborators
- Vestre Viken Hospital Trust, Hormone Laboratory, Aker University Hospital, Oslo, Norway
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 2 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.
Bone turnover markers (BTMs) are recommended as an important tool in follow-up of osteoporosis treatment. However, there is a lack of knowledge in the reliability of BTMs during and after glucocorticoid treatment. Glucocorticoids suppresses BTMs during treatment with at least 30% and, moreover, glucocorticoids increase the risk of fractures. Patients with an inflammatory joint disease are at increased risk of osteoporosis, and disease flares are often treated with glucocorticoids, which in turn can lead to loss in reliability of the BTMs in patients who also are on osteoporosis treatment.
There is a need of more knowledge on BTM changes during and after glucocorticoid treatment for optimized patientcare, reduced risk of side effects and reduced health economic costs.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| RApre | – | Drug: Glucocorticoid EffectPatients with a new diagnosis of rheumatoid arthritis and indication for initiating DMARD treatment with a bridging of oral glucocorticoid treatment. Women should be premenopausal and men younger than 50 years. |
| RApost | – | Drug: Glucocorticoid EffectPatients with a new diagnosis of rheumatoid arthritis and indication for initiating DMARD treatment with a bridging of oral glucocorticoid treatment. Women should be postmenopausal and men older than 50 years. |
| SpA | – | –Patients with a new diagnosis of spondyloarthritis and indication of DMARD treatment without glucocorticoid treatment. Women should be premenopausal and men younger than 50 years. |
| PsA | – | –Patients with a new diagnosis of psoriatic arthritis and indication of DMARD treatment without glucocorticoid treatment. Women should be premenopausal and men younger than 50 years. |
| IA | – | Drug: Glucocorticoid EffectPatients with an inflammatory joint disease on stable DMARD treatment weith indication of intraarticular glucocorticoid injection. Women should be premenopausal and men younger than 50 years. |
| IM | – | Drug: Glucocorticoid EffectPatients with an inflammatory joint disease on stable DMARD treatment weith indication of intramuscular glucocorticoid injection. Women should be premenopausal and men younger than 50 years. |
Who may qualify
- Ages
- 25 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a diagnosis of rheumatoid arthritis or spondyloarthritis or psoriatic arthritis
Key inclusion criteria (3 listed)
- diagnosis of inflammatory rheumatic joint disease
- indication of disease modifying treatment initiation with or without glucocorticoids OR
- stable DMARD treatment with parenteral glucocorticoid injection
Key exclusion criteria (8 listed)
- known osteoporosis or osteoporosis treatment
- women during the transitory phase
- oestrogen treatment
- any fracture within the last year
- chronic glucocorticoid 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 |
|---|---|---|
| Glucocorticoid EffectPatients with or without glucocorticoid treatment will be observed regarding the level of bone turnover markers (P1NP and CTX1) every 4 weeks til 6 months after the last glucocorticoid dose. | Drug | IA, IM, RApost, RApre |
Primary outcome
P1NP level 3 months after glucocorticoid termination
Time frame: september 2024 til december 2025
P1NP in a blood sample
3 secondary outcomes
P1NP level 6 months after glucocorticoid termination
Time frame: september 2024 til december 2025
CTX1 level 3 and 6 months after glucocorticoid termination
Time frame: september 2024 til december 2025
P1NP and CTX1 dynamic until 6 months after treatment of inflammation without glucocorticoids
Time frame: september 2024 til december 2025
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Osteoporosis
Enrolling by invitationPhase 3
Quanduzhong Capsules for Primary Osteoporosis
Primary Osteoporosis
RecruitingObservational study
A Natural History Study of Bone and Mineral Disorders
Tumor Induced Osteomalcia, Osteomalacia
RecruitingObservational study
A Study Evaluating the Performance of Using AI Software and Chest X-rays to Screen for Osteoporosis as Compared to Standard DXA Scans in Patients 50 Years and Older
Osteoporosis, Osteopenia
RecruitingObservational study
Bone Health in Adults With Duchenne Muscular Dystrophy: A Survey on Osteoporosis, Fractures and Treatment.
Duchenne Muscular Dystrophy (DMD)
RecruitingObservational study
REMS vs DXA for Osteoporosis Diagnosis and Fracture Risk Prediction
Osteoporosis Diagnosis, Bone Health
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis and Osteoporosis, Steroid Induced, run by Diakonhjemmet Hospital at 2 sites in Norway.
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 3 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 19 Aug 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 Norway. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Birgitte Nellemann Nellemann, MD PHD (+4747957020, birgittenellemann@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
P1NP level 3 months after glucocorticoid termination (time frame: september 2024 til december 2025). 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 19 Aug 2026.