A Study of Bonviva (Ibandronate) Once Monthly in Post-Menopausal Women With Osteopenia
Information source: Hoffmann-La Roche
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Post-Menopausal Osteopenia
Intervention: ibandronate [Bonviva/Boniva] (Drug); Placebo (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Hoffmann-La Roche Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche, +1 973 235 5000
Summary
This 2 arm study will evaluate the efficacy and safety of oral Bonviva 150mg once monthly
compared with placebo in post-menopausal women with osteopenia. Patients will be randomized
to receive either Bonviva 150mg po monthly, or placebo monthly. The anticipated time on study
treatment is 1-2 years, and the target sample size is 100-500 individuals.
Clinical Details
Official title: Double-Blind,Placebo-Controlled,Randomized, Multicenter Study to Assess the Efficiency and Safety of Oral Ibandronate 150 mg Once Monthly in Postmenopausal Women With Osteopenia
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Relative change in mean lumbar spine bone mineral density (BMD)
Secondary outcome: Absolute change in mean lumbar spine BMDRelative and absolute change in mean proximal femur BMD Percentage of responders Relative and absolute change in serum CTX AEs and laboratory parameters
Eligibility
Minimum age: 45 Years.
Maximum age: 60 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- women 45-60 years of age;
- post-menopausal;
- ambulatory.
Exclusion Criteria:
- vertebral fracture (except traumatic fracture such as in a motor vehicle accident);
- low-trauma osteoporotic fracture in any other bone;
- breast cancer diagnosed within last 20 years;
- other malignancy diagnosed within last 10 years, except successfully resected basal
cell cancer;
- treatment with any bisphosphonate within last 2 years;
- treatment with other drugs affecting bone metabolism within last 6 months.
Locations and Contacts
LAKEWOOD, Colorado 80227, United States
STUART, Florida 34996, United States
BETHESDA, Maryland 20817, United States
DETROIT, Michigan 48236, United States
ST LOUIS, Missouri 63110, United States
OMAHA, Nebraska 68131, United States
ALBUQUERQUE, New Mexico 87106, United States
CINCINNATI, Ohio 45224, United States
PORTLAND, Oregon 97213, United States
AMARILLO, Texas 79124, United States
RICHMOND, Virginia 23294, United States
NORFOLK, Virginia 23502, United States
Additional Information
Starting date: December 2005
Ending date: July 2007
Last updated: June 17, 2008
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