Osteogenesis and osteoclast inhibition in rheumatoid arthritis patients after more than 4 years of treatment with bisphosphonates or bisphosphonates with pitavastatin
| ISRCTN | ISRCTN45993953 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45993953 |
| Secondary identifying numbers | N/A |
- Submission date
- 22/08/2012
- Registration date
- 04/09/2012
- Last edited
- 06/02/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
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
Contact information
Scientific
Tokyo Metropolitan Bokutoh Hospital
4-23-15 Kohtohbashi Sumida-ku
Tokyo
130-8575
Japan
| Phone | +81 (0)3 3633 6151 |
|---|---|
| m_nagashima@bokutoh-hp.metro.tokyo.jp |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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 |
| Study acronym | ORAB |
| Study objectives | Significant difference between bisphosphonates and combination with bisphosphonates + statin for bone mineral density and bone metabolic markers |
| Ethics approval(s) | Tokyo Metropolitan Bokutoh Hospital, 27/03/2009 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Alendronate, etidronate, risedronate, pitavastatin |
| Primary outcome measure | 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 study start date | 01/06/2009 |
| Completion date | 31/03/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 77 male and female |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/06/2009 |
| Date of final enrolment | 31/03/2011 |
Locations
Countries of recruitment
- Japan
Study participating centre
130-8575
Japan
Sponsor information
Hospital/treatment centre
c/o Dr Masakazu Nagashima
4-23-15 Kohtohbashi Sumida-ku
Tokyo
130-8575
Japan
| Phone | +81 (0)3 3633 6151 |
|---|---|
| m_nagashima@bokutoh-hp.metro.tokyo.jp | |
"ROR" |
https://ror.org/01dk3f134 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
06/02/2017: Plain English summary added.
