Plain English Summary
Background and study aims:
Rheumatoid arthritis is a long-term condition that causes joint pain, swelling and stiffness. Bisphosphonates are a group of drugs that work by slowing bone loss. Statins are another group of drugs that may affect bone mineral density (the amount of bone mineral in bone tissue) and bone metabolism (the breakdown of old bone tissue and formation of new bone tissue). The aim of this study is to assess the effects of bisphosphonates, alone and in combination with statins, on the bone mineral density and bone metabolism of rheumatoid arthritis patients.
Who can participate?
Patients aged over 40 with rheumatoid arthritis who have been treated with bisphosphonates but not statins
What does the study involve?
Participants are randomly allocated into two groups. Participants in one group are treated with bisphosphonates and participants in the other group are treated with bisphosphonates and statins.
The blood levels of markers of bone metabolism are measured, and bone mineral density at the radius (forearm), lumbar spine (lower back), and femoral neck (thigh bone) are measured using X-ray scans over an 18-month period of treatment.
What are the possible benefits and risks of participating?
Participants may benefit from knowing about their bone mineral density and bone metabolic markers. The possible risks are the side effects of statins (muscle disease, liver function disturbance and jaundice).
Where is the study run from?
Tokyo Metropolitan Bokutoh Hospital (Japan)
When is the study starting and how long is it expected to run for?
June 2009 to March 2011
Who is funding the study?
Tokyo Metropolitan Bokutoh Hospital (Japan)
Who is the main contact?
Dr Masakazu Nagashima
m_nagashima@bokutoh-hp.metro.tokyo.jp
Trial website
Contact information
Type
Scientific
Primary contact
Dr Masakazu Nagashima
ORCID ID
Contact details
Tokyo Metropolitan Bokutoh Hospital
4-23-15 Kohtohbashi Sumida-ku
Tokyo
130-8575
Japan
+81 (0)3 3633 6151
m_nagashima@bokutoh-hp.metro.tokyo.jp
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Osteogenesis and osteoclast inhibition in rheumatoid arthritis patients after more than 4 years of treatment with bisphosphonates or bisphosphonates with pitavastatin over an 18 month follow up: a randomized controlled trial
Acronym
ORAB
Study hypothesis
Significant difference between bisphosphonates and combination with bisphosphonates + statin for bone mineral density and bone metabolic markers
Ethics approval
Tokyo Metropolitan Bokutoh Hospital, 27/03/2009
Study design
Randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Rheumatoid arthritis
Intervention
Bone metabolic markers (serum NTX, TRACP-5b, PICP and RANKL) were measured by ELISA. BMD of the radius, femoral neck, and lumbar spine were measured by DXA. The drugs administered in the Bis group were 35 mg of alendronate in 31 patients, 400 mg of etidronate in 4 patients, and 17.5 mg of risedronate in 7 patients. The drugs administered in the Bis+statin group were alendronate and 2 mg of pitavastatin in 26 patients, etidronate and pitavastatin in 5 patients, and risedronate and pitavastatin in 4 patients. A 400 mg dose of etidronate was administered orally between meals for 2 weeks, and was then withheld for the next 10 weeks. This 12-week period was defined as one cycle of etidronate treatment, and the cycle was repeated 6 times (72 weeks, 18 months).
Intervention type
Drug
Phase
Not Applicable
Drug names
Alendronate, etidronate, risedronate, pitavastatin
Primary outcome measures
Bone mineral densities of the radius, lumbar spine and femoral neck and bone mineral markers of NTX, TRAP-5b, PICP and RANKL at baseline, 6, 12 and 18 months
Secondary outcome measures
Percentage changes in all of the parameters (bone mineral densities of the radius, lumbar spine and femoral neck, bone mineral markers of NTX, TRAP-5b, PICP and RANKL) at 0, 6, 12, 18 months
Overall trial start date
01/06/2009
Overall trial end date
31/03/2011
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged over 40 years old
2. Pre-menopausal patients with rheumatoid arthritis, and not planning pregnancy
3. Postmenopausal patients
4. Patients receiving bisphosphonates
5. Patients receiving bisphosphonates and not receiving statins who diagnozed hyperlipidemia
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
77 male and female
Participant exclusion criteria
1. Adverse or allergic reactions to statins
2. Severe liver function disturbance
3. Severe renal function disturbance
4. Patients with rheumatoid arthritis during pregnancy or during nuring
5. Patients with probability of pregnancy
6. Patients receiving statins
7. Patients with other sever complications
Recruitment start date
01/06/2009
Recruitment end date
31/03/2011
Locations
Countries of recruitment
Japan
Trial participating centre
Tokyo Metropolitan Bokutoh Hospital
Tokyo
130-8575
Japan
Sponsor information
Organisation
Tokyo Metropolitan Bokutoh Hospital (Japan)
Sponsor details
c/o Dr Masakazu Nagashima
4-23-15 Kohtohbashi Sumida-ku
Tokyo
130-8575
Japan
+81 (0)3 3633 6151
m_nagashima@bokutoh-hp.metro.tokyo.jp
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Tokyo Metropolitan Bokutoh Hospital (Japan)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary