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

NCT ID: NCT00551174

Last Updated: 2011-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 781 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-10-31
• Study Completion Date: 2008-11-30

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.

Conditions

Post-Menopausal Osteoporosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

ibandronate [Bonviva/Boniva]

Intervention Type: DRUG

3 mg IV every 3 months for 3 years. All patients received a minimum of calcium 500 milligrams/day (upper limit 1500 mg/day) and Vitamin D 400 Internation Units/day (IU/day).

2

Group Type: ACTIVE_COMPARATOR

ibandronate [Bonviva/Boniva]

Intervention Type: DRUG

2 mg IV every 2 months for 3 years. All patients received a minimum of calcium 500 milligrams/day (upper limit 1500 mg/day) and Vitamin D 400 Internation Units/day (IU/day).

Interventions

ibandronate [Bonviva/Boniva]

3 mg IV every 3 months for 3 years. All patients received a minimum of calcium 500 milligrams/day (upper limit 1500 mg/day) and Vitamin D 400 Internation Units/day (IU/day).

Intervention Type: DRUG

ibandronate [Bonviva/Boniva]

2 mg IV every 2 months for 3 years. All patients received a minimum of calcium 500 milligrams/day (upper limit 1500 mg/day) and Vitamin D 400 Internation Units/day (IU/day).

Intervention Type: DRUG

Eligibility Criteria

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Hoffmann-La Roche

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Gainesville, Georgia, United States

St Louis, Missouri, United States

Omaha, Nebraska, United States

Bismarck, North Dakota, United States

Fargo, North Dakota, United States

Madison, Wisconsin, United States

St Leonards, , Australia

Sydney, , Australia

Brussels, , Belgium

Liège, , Belgium

Pilsen, , Czechia

Prague, , Czechia

Aalborg, , Denmark

Aarhus, , Denmark

Ballerup Municipality, , Denmark

Copenhagen, , Denmark

Vejle, , Denmark

Lyon, , France

Orléans, , France

Berlin, , Germany

Essen, , Germany

Hamburg, , Germany

Budapest, , Hungary

Arenzano, , Italy

Siena, , Italy

Valeggio sul Mincio, , Italy

Mexico City, , Mexico

Monterrey, , Mexico

Haugesund, , Norway

Oslo, , Norway

Stavanger, , Norway

Grudziądz, , Poland

Krakow, , Poland

Krakow, , Poland

Cape Town, , South Africa

Pretoria, , South Africa

Sommerset West, , South Africa

Madrid, , Spain

Aberdeen, , United Kingdom

Countries

United States; Australia; Belgium; Czechia; Denmark; France; Germany; Hungary; Italy; Mexico; Norway; Poland; South Africa; Spain; United Kingdom

Other Identifiers

MA17904

Identifier Type: -

Identifier Source: org_study_id