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

Phase 4

Completed

• Conditions: Postmenopausal Osteoporosis
• Interventions: Drug: Placebo; Drug: ibandronate

• Registration Number: NCT00545051
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2007-10-16
• Study First Submitted QC: 2007-10-16
• Study First Posted: 2007-10-17
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Status Verified: 2016-04
• Results First Submitted: 2016-04-05
• Results First Submitted QC: 2016-04-05
• Last Update Submitted: 2016-04-05
• Results First Posted: 2016-05-12
• Last Update Posted: 2016-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 140

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants received monthly oral placebo for 12 months.
Ibandronate	ibandronate	Participants received monthly oral ibandronate (150 milligrams \[mg\]) for 12 months.

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at Month 12	Baseline and 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.

Secondary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Mean Lumbar Spine BMD at Month 6	Baseline and 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.
Percent Change From Baseline in Bone Turnover Markers at Month 1, Month 6 and Month 12	Baseline and Months 1, 6 and 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.
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	Month 6	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.
Percent Change From Baseline in Mean Total Hip BMD at Month 6 and Month 12	Baseline and Months 6 and 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.