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

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

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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Absolute Change From Baseline in Mean Lumbar Spine (L2 - L4) BMD

Relative Percent (%) Change From Baseline in Mean Lumbar Spine (L2 - L4) Bone Mineral Density (BMD)

Secondary outcome:

Absolute Change From Baseline in Mean Total Hip BMD

Relative Percent Change From Baseline in Mean Total Hip BMD

Absolute Change From Baseline of Trough Serum CTX

Relative Percent Change From Baseline of Trough Serum CTX

Eligibility

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

Criteria:

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.

Locations and Contacts

Liege 4020, Belgium

Merksem 2170, Belgium

Sao Paulo 04026-000, Brazil

Plzen 305 99, Czech Republic

Praha 128 00, Czech Republic

Aalborg 9000, Denmark

Ballerup 2750, Denmark

Vejle 7100, Denmark

Lyon 69000, France

Berlin 12200, Germany

Hannover 30167, Germany

Balatonfuered 8230, Hungary

Budapest 1036, Hungary

Budapest 1083, Hungary

Kiskunhalas 6400, Hungary

Zalaegerszeg 8900, Hungary

Siena 53100, Italy

Leon 37000, Mexico

Obregon 85100, Mexico

Haugesund 5507, Norway

Stavanger 4010, Norway

Krakow 31-501, Poland

Warszawa 04-730, Poland

Barcelona 08907, Spain

Madrid 28041, Spain

Southampton SO16 6YD, United Kingdom

Loma Linda, California 92357, United States

Lakewood, Colorado 80260, United States

Omaha, Nebraska 68131, United States

Livingston, New Jersey 07039, United States

Portland, Oregon 97213, United States

Additional Information

Clinical Study Report Synopsis

Starting date: May 2004
Last updated: August 7, 2015

Page last updated: August 23, 2015

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