A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Previously Treated With Bonviva

Phase 4

Completed

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

• Registration Number: NCT00081653
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This 2 arm study will assess the long-term efficacy and safety of oral treatment with 100mg or 150mg Bonviva in women with post-menopausal osteoporosis who have previously completed Bonviva study BM16549 (MOBILE study). Patients will receive Bonviva either 100mg po monthly, or 150mg po monthly. Patients will also receive daily supplementation with vitamin D and calcium. The anticipated time of study treatment is 2+ years, and the target sample size is 500+ individuals.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2004-04-19
• Study First Submitted QC: 2004-04-20
• Study First Posted: 2004-04-21
• Study Start: 2004-05
• Primary Completion: 2007-11
• Study Completion: 2008-05
• Results First Submitted: 2008-12-22
• Results First Submitted QC: 2009-06-02
• Results First Posted: 2009-07-21
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-13
• Last Update Posted: 2017-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 719

Inclusion Criteria

• successful completion of Bonviva study BM16549, with at least 75% compliance;
• ambulatory.

Exclusion Criteria

• malignant disease diagnosed within the previous 12 years (except basal cell cancer that has been successfully removed);
• breast cancer diagnosed within the previous 22 years.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Absolute Change From Baseline in Mean Lumbar Spine (L2 - L4) BMD	Baseline and Months 12, 24 and 36	Absolute change from Baseline in mean BMD of the lumbar spine (L2 - L4) measured as grams per square centimeter (g/cm\^2). This was baseline of Study MA17903 after two years of treatment in the core study (BM16549 \[NCT00081653\]).
Relative Percent (%) Change From Baseline in Mean Lumbar Spine (L2 - L4) Bone Mineral Density (BMD)	Baseline and Months 12, 24 and 36	BMD was measured by a single dual-energy X-ray absorptiometry (DXA) scan of the lumbar spine (BMD of at least 2 vertebrae \[L2-L4\] that were not fractured and not affected by osteoarthritis to such a degree that BMD measurement would be compromised) at the time of enrollment and at Months 12, 24 and 36. This was baseline of Study MA17903 after two years of treatment in the core study (BM16549 \[NCT00081653\]).

Secondary Outcome Measures

Name	Time	Method
Absolute Change From Baseline in Mean Total Hip BMD	Baseline and 12, 24 and 36 months	BMD was measured by a single DXA scan of the hip. Scores between -1 and -2.5 indicate Osteopenia (thin bones). Less than -2.5 indicate Osteoporosis (porous bones).
Relative Percent Change From Baseline in Mean Total Hip BMD	Baseline, 12, 24 and 36 months	BMD was measured by a single DXA scan of the hip. Scores between -1 and -2.5 indicate Osteopenia (thin bones). Less than -2.5 indicate Osteoporosis (porous bones).
Relative Percent Change From Baseline of Trough Serum CTX	Baseline, 6,12, 24 and 36 months	CTX is a measure of bone resorption and is measured as nanograms per milliliter (ng/mL). Blood samples for the Month 6 values were collected 6 days after the 6-month dose; therefore, the Month 6 values are not true 'trough' values.
Absolute Change From Baseline of Trough Serum CTX	Baseline, 6, 12, 24 and 36 months	CTX is a measure of bone resorption and is measured as ng/mL. Blood samples for the Month 6 values were collected 6 days after the 6-month dose; therefore, the Month 6 values are not true 'trough' values.