A Study of Once Monthly Bonviva (Ibandronate) in Prevention of Glucocorticoid-Induced Osteoporosis.

Study Overview
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Brief Summary
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This 2 arm study will investigate the efficacy and safety of Bonviva (150mg po monthly) in the prevention of glucocorticoid-induced osteoporosis in post-menopausal women. Patients will be randomized to receive either Bonviva 150mg po or placebo monthly, with vitamin D and calcium supplementation. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.

Official Title
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A Randomized, Double-blind Study to Evaluate the Effect of Once Monthly Bonviva on Lumbar Bone Mineral Density in the Prevention of Glucocorticoid-induced Osteoporosis in Post-menopausal Women

Conditions
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Postmenopausal Osteoporosis

Intervention / Treatment
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* Drug: Placebo
* Drug: ibandronate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: post-menopausal women, 50-85 years of age; any inflammatory rheumatoid disease including polymyalgia rheumatica; receiving treatment with 5-15 mg/day of prednisolone. Exclusion Criteria: previous treatment with an iv bisphosphonate at any time; previous treatment with an oral bisphosphonate within the last 6 months, >1 month of treatment within last year, or >3 months of treatment within last 2 years; treatment with parathyroid hormone in last 2 years; inability to stand or sit in an upright position for at least 60 minutes; inability to swallow a tablet whole; history of major gastrointestinal disease.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ibandronate<br>Participants received monthly oral ibandronate (150 milligrams [mg]) for 12 months. | Drug: ibandronate<br>* 150mg po monthly for 12 months<br>* Other names: Bonviva/Boniva;|
| Placebo Comparator: Placebo<br>Participants received monthly oral placebo for 12 months. | Drug: Placebo<br>* po monthly for 12 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at Month 12 | Lumbar spine BMD was measured at Baseline, and Months 6 and 12 using dual-energy x-ray absorptiometry (DXA). Percent change from Baseline to Month 12 was calculated using analysis of covariance. | Baseline and Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in Mean Lumbar Spine BMD at Month 6 | Lumbar spine BMD was measured at Baseline and Month 6 using DXA. Percent change from Baseline to Month 6 was calculated using analysis of covariance. | Baseline and Month 6 | 
| Percent Change From Baseline in Mean Total Hip BMD at Month 6 and Month 12 | Left total hip BMD was measured by DXA at Baseline, and Months 6 and 12. If there was prosthesis of left hip, the measurement of right total hip BMD was done by DXA. Percent change from Baseline to Months 6 and 12 was calculated using analysis of (co)variance for repeated measurements. | Baseline and Months 6 and 12 | 
| Percent Change From Baseline in Bone Turnover Markers at Month 1, Month 6 and Month 12 | Serum C-terminal Telopeptide of Type 1 Collagen (sCTX), Serum Procollagen Type 1 N-terminal Propeptide (P1NP) and Serum Bone Tartrate-resistant Acid Phosphatase Isoform 5b (TRACP) are measures of bone resorption and are measured as nanograms per milliliter (ng/mL). Percent change from Baseline to Months 1, 6 and 12 was calculated using analysis of covariance for repeated measurements. | Baseline and Months 1, 6 and 12 | 
| Percentage of Participants Withdrawn Due to Worsening in BMD at 6 Months and/or Worsening in BMD at Least 7 Percent (%) at Any Site at 6 Months | Worsening in BMD was defined as BMD T-score at any site less than or equal to (≤) - 2.5 standard deviations and/or worsening in BMD of at least 7% at any site. | Month 6 |