Condition category
Musculoskeletal Diseases
Date applied
22/08/2012
Date assigned
04/09/2012
Last edited
04/09/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 2

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 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 March 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 below 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

Other

Phase

Not Applicable

Drug names

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 the start of treatment.

These outcomes of bone metabolic markers and BMD in Bis and Bis+statin groups were measured at base line, 6, 12 and 18 months during 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 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

Publication citations

Additional files

Editorial Notes