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

Study Overview
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Brief Summary
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This study was to investigate the efficacy of oral monthly ibandronate in the management of glucocorticoid induced osteoporosis in women with rheumatoid arthritis.

Detailed Description
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Glucocorticoid therapy is associated with a number of significant side effects, of which bone loss resulting in glucocorticoid-induced osteoporosis and an increase in fracture risk is the most serious. However studies show that many patients treated with glucocorticoids do not receive treatment to prevent bone loss. There exist 5 large randomized controlled clinical trials providing evidence that the bisphosphonates etidronate, alendronate, and risedronate are effective in both the prevention and the treatment of glucocorticoid-induced osteoporosis. Significant increases in BMD with bisphosphonate treatment, most consistently observed in lumbar spine, were seen in patients with many different glucocorticoid-treated disorders; most often RA and polymyalgia rheumatica, and occurred generally irrespective of patient age, sex and menopausal status in women. In addition, statically significant reductions in the absolute risk and relative risk of incident radiographic vertebral fractures were demonstrated after 1 year of treatment with risedronate. A similar significant reduction in the risk of incident radiographic vertebral fractures was seen in alendronate treated patients who completed 2 years of a study of alendronate in the prevention and treatment of glucocorticoid-induced osteoporosis. There exists a data about Ibandronate which reported that intermittent intravenous ibandronate reduced vertebral fracture risk in corticosteroid-induced osteoporosis. However, there is no report about oral monthly ibandronate. Current oral bisphosphonates, which are given either daily or weekly, are associated with stringent, inconvenient dosing schedules. Less frequent dosing may provide great acceptability. The objective of this study was to investigate the efficacy of oral monthly ibandronate in women receiving long-term glucocorticoids.

Official Title
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Efficacy of Monthly Ibandronate in Women With Rheumatoid Arthritis and Reduced Bone Mineral Density Receiving Long-term Glucocorticoids

Conditions
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Rheumatoid Arthritis, Osteoporosis, Osteopenia

Intervention / Treatment
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* Drug: Ibandronate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ibandronate treatment<br>Ibandronate 150mg PO once every 4 weeks | Drug: Ibandronate<br>* monthly dosage of ibandronate 150mg<br>|
| Placebo Comparator: Placebo arm<br>Placebo PO once every 4 weeks | Drug: Placebo<br>* monthly dosage of placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in L1-4 bone mineral density compared with baseline |  | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in femur bone mineral density compared with baseline |  | 48 weeks | 
| Changes in L1-4 and femur bone mineral density compared with baseline |  | 24 weeks | 
| Changes in C-telopeptide compared with baseline |  | 24 and 48 weeks | 
| Cumulative incidence of vertebral fracture |  | 48 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rheumatoid arthritis, Glucocorticoid induced osteoporosis, Vertebral fracture