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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN45993953

Enrollment

Registered

2012-09-04

Start date

2009-06-01

Completion date

Unknown

Last updated

2017-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid arthritis Musculoskeletal Diseases Other rheumatoid arthritis

Interventions

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 wer

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

Japan

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026