DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Post-Menopausal Osteoporosis

Intervention: ibandronate [Bonviva/Boniva] (Drug); ibandronate [Bonviva/Boniva] (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche


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.

Clinical Details

Official title: Open Label, Parallel Group, Multicenter Study of Two Intravenous (IV) Ibandronate Dose Regimens (2 mg Every 2 Months and 3 mg Every 3 Months) in Women With Postmenopausal Osteoporosis Who Completed Trial BM16550

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Relative Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at 12, 24 and 36 Months

Secondary outcome:

Relative Percent Change From Baseline in Mean Total Hip BMD at 12, 24 and 36 Months

Relative Percent Change From Baseline in Serum C-telopeptide Crosslinks of Type I Collagen (CTX) at Trough at 6, 12, 24 and 36 Months

Relative Percent Change From Baseline in Post-dose Suppression of Serum CTX at 6 Months


Minimum age: N/A. Maximum age: N/A. Gender(s): Female.


Inclusion Criteria:

- Successful completion of Bonviva study BM16550 (NCT00048074), with at least 75%


- 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

Locations and Contacts

St. Leonards 2139, Australia

Sydney 3129, Australia

Bruxelles 1180, Belgium

Liege 4020, Belgium

Plzen 305 99, Czech Republic

Praha 128 00, Czech Republic

Aalborg 9000, Denmark

Ballerup 2750, Denmark

København 1399, Denmark

Vejle 7100, Denmark

Århus 8000, Denmark

Lyon 69000, France

Orleans 45032, France

Berlin 12200, Germany

Essen 45276, Germany

Hamburg 20354, Germany

Budapest 1036, Hungary

Arenzano 16011, Italy

Siena 53100, Italy

Valeggio Sul Mincio 37067, Italy

Mexico City 11000, Mexico

Monterrey 64460, Mexico

Haugesund 5507, Norway

Oslo 0176, Norway

Stavanger 4010, Norway

Grudziadz 86-300, Poland

Krakow 31-501, Poland

Krakow 30-510, Poland

Cape Town 7500, South Africa

Pretoria, South Africa

Sommerset West 7129, South Africa

Madrid 28046, Spain

Aberdeen AB25 2ZD, United Kingdom

Gainesville, Georgia 30501, United States

St Louis, Missouri 63110, United States

Omaha, Nebraska 68131, United States

Bismarck, North Dakota 58501, United States

Fargo, North Dakota 58103, United States

Madison, Wisconsin 53792, United States

Additional Information

Clinical Study Report Synopsis

Starting date: October 2004
Last updated: July 20, 2011

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017