A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Who Have Received Previous Bonviva Treatment

Phase 4

Completed

• Conditions: Post-Menopausal Osteoporosis
• Interventions: Drug: ibandronate [Bonviva/Boniva]

• Registration Number: NCT00551174
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This 2-arm study was designed to assess the long-term safety and tolerability of intravenous (IV) treatment with 2 mg or 3 mg Bonviva in women with post-menopausal osteoporosis who had previously completed Bonviva study BM16550 (DIVA study; NCT00048074). Patients received Bonviva either 2 mg IV every 2 months, or 3 mg IV every 3 months. Patients also received daily supplementation with vitamin D and calcium. The anticipated time on study treatment was 2+ years, and the target sample size was 500+ individuals.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2007-10-29
• Study First Submitted QC: 2007-10-29
• Study First Posted: 2007-10-30
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Results First Submitted: 2009-06-30
• Results First Submitted QC: 2011-04-28
• Results First Posted: 2011-05-30
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-20
• Last Update Posted: 2011-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 781

Inclusion Criteria

• Successful completion of Bonviva study BM16550 (NCT00048074), with at least 75% compliance
• Ambulatory

Exclusion Criteria

• Patients who completed the Bonviva study BM16550 (NCT00048074) >3 months before the planned start date for this study
• Malignant disease diagnosed since inclusion into previous study
• Treatment with drugs affecting bone metabolism since inclusion into previous study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	ibandronate [Bonviva/Boniva]	-
1	ibandronate [Bonviva/Boniva]	-

Primary Outcome Measures

Name	Time	Method
Relative Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at 12, 24 and 36 Months	Baseline,12, 24 and 36 months	Relative change percent(%) from baseline of MA17904 and BM16550 (NCT00048074) in mean lumbar spine (L2-L4) BMD at 12, 24 and 36 months (i.e., 3, 4 and 5 years after initiation of BM16550)- Study MA17940.Percent change=\[(measure at time t - measure at baseline)/measure at baseline\]\*100%, where t=12, 24 and 36 months. The baseline value is used as a reference to calculate the relative change from baseline.

Secondary Outcome Measures

Name	Time	Method
Relative Percent Change From Baseline in Mean Total Hip BMD at 12, 24 and 36 Months	Baseline,12, 24 and 36 months	Relative change percent (%) from baseline of MA17904 and BM16550 (NCT00048074) in mean total hip BMD at 12, 24 and 36 months (i.e., 3, 4 and 5 years after initiation of BM16550)- Study MA17904. Percent change=\[(measure at time t - measure at baseline)/measure at baseline\]\*100%, where t=12, 24 and 36 months. The baseline value is used as a reference to calculate the relative change from baseline.
Relative Percent Change From Baseline in Serum C-telopeptide Crosslinks of Type I Collagen (CTX) at Trough at 6, 12, 24 and 36 Months	Baseline, 6, 12, 24 and 36 months (i.e., 2.5, 3, 4 and 5 years after initiation of BM16550)	Relative percent (%) change from baseline of MA17904 and BM16550 (NCT00048074) in serum C-telopeptide crosslinks of type I collagen (CTX) at trough at 6, 12, 24 and 36 months- Study MA17904. Percent change=\[(measure at time t - measure at baseline)/measure at baseline\]\*100%, where t=6, 12, 24 and 36 months. The baseline value is used as a reference to calculate the relative change from baseline.
Relative Percent Change From Baseline in Post-dose Suppression of Serum CTX at 6 Months	Baseline, 6 months	Relative percent (%) change from MA17904 baseline of post-dose suppression of serum C-telopeptide crosslinks of type I collagen (CTX) at 6 months- Study MA17904. Percent change=\[(measure at time t - measure at baseline)/measure at baseline\]\*100%, where t= 6 months. The baseline value is used as a reference to calculate the relative change from baseline.