Osteogenesis and osteoclast inhibition in rheumatoid arthritis patients after more than 4 years of treatment with bisphosphonates or bisphosphonates with pitavastati

Not Applicable

Completed

• Conditions: Rheumatoid arthritis; Musculoskeletal Diseases; Other rheumatoid arthritis

• Registration Number: ISRCTN45993953
• Lead Sponsor: Tokyo Metropolitan Bokutoh Hospital (Japan)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09-04
• Last Update Posted: 27 February 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 77

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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