MOBILE Study - A Study of Bonviva (Ibandronate) Regimens in Women With Post-Menopausal Osteoporosis

Condition(s) targeted: Post-Menopausal Osteoporosis

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

Phase: Phase 3

Status: Completed

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche, +1 973 235 5000

This study will compare the efficacy and safety of different treatment regimens of oral Bonviva tablets in women with post-menopausal osteoporosis. 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.

Official title: A Randomized, Double-Blind Study Comparing the Effect of Monthly Versus Daily Treatment With Oral Bonviva on Lumbar Bone Mineral Density in Women With Osteoporosis

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Relative change (%) from baseline in mean lumbar spine bone mineral density (BMD)

Secondary outcome:

Relative change in mean lumbar spine BMD

Relative and absolute change in total hip, trochanter, femoral neck BMD

Percentage of responders

Change from baseline in fasting serum CTX

AEs, laboratory parameters

Minimum age: 55 Years. Maximum age: 80 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- women 55-80 years of age;

- post-menopausal for >= 5 years;

- ambulatory.

Exclusion Criteria:

- malignant disease diagnosed within the previous 10 years (except basal cell cancer

that has been successfully removed);

- breast cancer within the previous 20 years;

- allergy to bisphosphonates;

- previous treatment with an intravenous bisphosphonate at any time;

- previous treatment with an oral bisphosphonate within the last 6 months, >1 month of

treatment within the last year, or >3 months of treatment within the last 2 years.

ADELAIDE 5000, Australia

PARKVILLE 3052, Australia

PERTH 6979, Australia

LIEGE 4020, Belgium

MERKSEM 2170, Belgium

CAMPINAS 13083-970, Brazil

SAO PAULO 04026-000, Brazil

CURITIBA 80060-240, Brazil

PORTO ALEGRE 90035-003, Brazil

PRAHA 128 00, Czech Republic

PRAHA 169 02, Czech Republic

PLZEN 305 99, Czech Republic

BALLERUP 2750, Denmark

VEJLE 7100, Denmark

AALBORG 9000, Denmark

CAEN 14033, France

LYON 69000, France

BERLIN 12200, Germany

HANNOVER 30167, Germany

BUDAPEST 1083, Hungary

BUDAPEST 1036, Hungary

BALATONFUERED 8230, Hungary

ZALAEGERSZEG 8900, Hungary

KISKUNHALAS 6400, Hungary

VALEGGIO SUL MINCIO 37067, Italy

SIENA 53100, Italy

LEON 37000, Mexico

OBREGON 85100, Mexico

HAUGESUND 5507, Norway

OSLO 0176, Norway

STAVANGER 4010, Norway

KRAKOW 31-501, Poland

WARSZAWA 04-730, Poland

BUCHAREST 011025, Romania

CAPE TOWN 7500, South Africa

JOHANNESBURG 2196, South Africa

MADRID 28041, Spain

BARCELONA 08907, Spain

ZÜRICH 8091, Switzerland

SOUTHAMPTON SO16 6YD, United Kingdom

LONDON E11 1NR, United Kingdom

LIVERPOOL L22 0LG, United Kingdom

CARDIFF CF64 2XX, United Kingdom

CALGARY, Alberta T2N 4N1, Canada

VANCOUVER, British Columbia V5Z 2N6, Canada

IRVINE, California 92618, United States

RANCHO MIRAGE, California 92270, United States

LOMA LINDA, California 92357, United States

OAKLAND, California 94612, United States

LOS ANGELES, California 90211, United States

LAKEWOOD, Colorado 80227, United States

GAINESVILLE, Florida 32607, United States

WHEATON, Maryland 20902, United States

BETHESDA, Maryland 20817, United States

ST LOUIS, Missouri 63110, United States

BILLINGS, Montana 59120, United States

OMAHA, Nebraska 68131, United States

LIVINGSTON, New Jersey 07039, United States

ALBUQUERQUE, New Mexico 87106, United States

TORONTO, Ontario M5S 1B2, Canada

PORTLAND, Oregon 97213, United States

WYOMISSING, Pennsylvania 19610, United States

QUEBEC CITY, Quebec G1V 3M7, Canada

SAN ANTONIO, Texas 78229-4801, United States

RICHMOND, Virginia 23294, United States

SEATTLE, Washington 98144, United States

MADISON, Wisconsin 53792, United States

Ending date: April 2005
Last updated: June 17, 2008