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

Tracking Information

First Received Date ^ICMJE

April 19, 2004

Last Updated Date

June 2, 2009

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Relative (%) Change From MA17903 Baseline in Mean Lumbar Spine (L2 - L4) BMD [ Time Frame: Assessed at Baseline +12, 24, and 36 months ] [ Designated as safety issue: No ]
Absolute (g/cm2) Change From MA17903 Baseline in Mean Lumbar Spine (L2 - L4) BMD [ Time Frame: Assessed at baseline +12, 24 and 36 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Efficacy: Relative change in mean lumbar spine bone mineral density (BMD) at 12, 24, 36 months

Change History

Complete list of historical versions of study NCT00081653 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Relative (%) and Absolute (g/cm2) Change From MA17903 Baseline in Mean Total Hip BMD [ Time Frame: 12, 24 and 36 months ] [ Designated as safety issue: No ]
Relative (%) and Absolute (ng/mL) Change From MA17903 Baseline of Median Trough Serum CTX [Type I Collagen] [ Time Frame: 12, 24 and 36 months ] [ Designated as safety issue: No ]
Relative (%) and Absolute (ng/mL) Change From MA17903 Baseline of Median Post Dose Suppression of Serum CTX [Type I Collagen] [ Time Frame: 6 months of treatment ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Efficacy: Relative change in mean total hip BMD at 12, 24, 36 months, relative change in serum CTX at trough and peak suppression..Safety: Adverse events and laboratory tests

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Double-Blind, Partially Randomized, Parallel Group, Multicenter Study to Assess the Efficacy and Safety of 100 mg and 150 mg Monthly Oral Ibandronate in Women With Postmenopausal Osteoporosis Having Completed the Phase III Oral Ibandronate Trial BM16549

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

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Post-Menopausal Osteoporosis

Intervention ^ICMJE

Drug: ibandronate [Bonviva/Boniva]

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

719

Completion Date

May 2008

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Female

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Belgium, Brazil, Czech Republic, Denmark, France, Germany, Hungary, Italy, Mexico, Norway, Poland, Spain, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00081653

Responsible Party

Clinical Trials, Study Director, Hoffmann-La Roche

Study ID Numbers ^ICMJE

MA17903

Study Sponsor ^ICMJE

Hoffmann-La Roche

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

Information Provided By

Hoffmann-La Roche

Verification Date

June 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP