BOOGIE
Dynamics in BOne turnover markers in relation to Glucocorticoid treatment in patients with an Inflammatory joint disEase
Project managers
ABOUT THE PROJECT
BOOGIE is an observational study investigating changes in the bone markers P1NP and CTX-1 (measured in blood samples) during and after treatment of inflammation – with or without cortisone preparations – in patients with inflammatory joint diseases.
Bone markers can be used to monitor osteoporosis (bone fragility) and may help reduce the need for bone density measurements in follow-up. This may free up capacity for examinations of patients who have not yet been diagnosed with osteoporosis.
Osteoporosis (bone thinning) is very common in the population and even more common in patients with rheumatological diseases. Fractures due to osteoporosis can cause significant functional loss and increased mortality. The condition is underdiagnosed and undertreated.
Treatment usually consists of medications that prevent bone breakdown, so-called antiresorptive drugs. These reduce bone turnover and lower the risk of fractures.
In Norway, it has become common to use bone markers to follow up osteoporosis treatment. Low bone marker values indicate a good treatment effect of the antiresorptive drugs. The specific markers measured in blood tests are N-terminal propeptide of type 1 procollagen (P1NP) and C-telopeptide of type 1 collagen (CTX-1). After 3–6 months, bone markers can indicate whether the treatment is working, and possibly provide a basis for early adjustment. The markers can also help determine the time for the next dose of zoledronate infusion.
Bone markers are affected by several factors, including fractures, inflammation, kidney failure, and cortisone therapy. Cortisone is often used in the treatment of rheumatological diseases, but has several negative effects on the skeleton and increases the risk of osteoporosis and fractures. Cortisone can also lower bone marker values, regardless of actual bone turnover.
There are no studies that have determined the dose of cortisone that does not affect bone markers, or how long bone marker values remain affected after cortisone treatment. It is also not clear to what extent inflammation or treatment of inflammation without cortisone affects bone markers.
Clinicians treating osteoporosis need clarity on when bone markers can be used as a reliable measure in follow-up, and when they cannot. The knowledge from the BOOGIE study can help reduce the need for bone density measurements and free up capacity to examine undiagnosed patients. This could have a major impact on waiting lists throughout Norway. The results from the study can be quickly implemented in clinical guidelines both nationally and internationally.
WHO CAN JOIN?
Eligible participants are adult patients with active inflammatory joint disease who either:
- should start treatment with disease-modifying anti-rheumatic drugs (DMARD) , or
- should receive a cortisone injection into the joint or muscle, without changing the DMARD treatment .
The main group consists of newly diagnosed patients with rheumatoid arthritis who are about to start treatment with Methotrexate and Prednisolone .
Subgroups:
- Patients with psoriatic arthritis or spondyloarthritis who are about to start DMARD treatment.
- Patients with rheumatoid arthritis, psoriatic arthritis or spondyloarthritis who are to receive a cortisone injection into the joint or muscle, without a change in DMARD treatment .
Exclusion criteria:
- Known osteoporosis or current/previous treatment for osteoporosis
- Cortisone treatment in the past year
- Breakage in the past year
- Active cancer
- Women in menopause (perimenopause) or undergoing treatment with estrogen
- Chronic renal failure
Study personnel assess whether participants meet the inclusion criteria and have no exclusion criteria.
WHAT DOES THE STUDY INVOLVE?
Patients are recruited from the rheumatology outpatient clinics at Diakonhjemmet Hospital and Drammen Hospital .
Those who wish to participate must take a blood sample before starting cortisone or other treatment for inflammatory joint disease. The samples are analyzed for P1NP and CTX-1 at the Medical Biochemistry Department at Drammen Hospital. Samples from Diakonhjemmet are sent there every six weeks.
Blood samples are taken:
- Every four weeks, until six months after completion of cortisone treatment.
- A total of 7–10 blood samples per participant.
Participants must also fill out:
- A comprehensive questionnaire at start-up.
- A short questionnaire every four weeks.
The forms are completed digitally with BankID, and participants receive a link by email. The short forms also serve as reminders for blood tests. The content of the forms focuses on factors that can affect bone marker values, such as fractures, cortisone use, infections or new illnesses.
Participants in the BOOGIE study do not need to attend any additional hospital check-ups beyond blood sampling. If blood sampling is part of the clinical follow-up of the patient's inflammatory joint disease, the BOOGIE samples will be coordinated with these, reducing the number of additional blood samples.
THE PROJECT
The entire project consists of
Project managers:
Birgitte Nellemann (Diakonhjemmet Hospital)
Tove Tveitan Borgen (Vestre Viken HF, Drammen)
Project staff:
Anne Christine Hanshus Brekke (Diakonhjemmet Hospital)
Sidsel Arnkværn (Diakonhjemmet Hospital)
Cecilie Handberg Nørgaard (Vestre Viken HF, Drammen)
Want to know more about BOOGIE?
Contact the study group by email: