Overview

Efficacy of Monthly Ibandronate in Women With RA and Reduced Bone Mineral Density Receiving Long-term Steroids

Status:
Completed
Trial end date:
2014-04-01
Target enrollment:
0
Participant gender:
Female
Summary
This study was to investigate the efficacy of oral monthly ibandronate in the management of glucocorticoid induced osteoporosis in women with rheumatoid arthritis.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Yeong-Wook Song
Treatments:
Diphosphonates
Glucocorticoids
Ibandronic Acid
Criteria
Inclusion Criteria:

- Rheumatoid arthritis fulfilling the 1987 ACR criteria

- Women equal and above 18 years, less than 75 years old

- L1-4 T score less than -1.0 and equal or above -3.0 SD measured by DXA (Dual Energy
X-ray Absorptiometry)

- Patient must have taken prednisolone 5mg or its equivalent for more than 3 consecutive
months within 1 year

- Patient who would be taking glucocorticoids for more than 3 months after enrollment

Exclusion Criteria:

- Patient with vertebral fractures or nonvertebral fractures associated with
osteoporosis

- Patient diagnosed with malignancy within 5 years

- Patient with endocrine dysfunction

- RA functional class 4

- Patient who took bisphosphonates within 6 months

- Patient on medication affecting bone mineral metabolism