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A Study of Bonviva (Ibandronate) Once Monthly in Post-Menopausal Women With Osteopenia

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 Osteopenia

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

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

Secondary outcome:

Absolute change in mean lumbar spine BMD

Relative 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

Norfolk, Virginia 23502, United States

Richmond, Virginia 23294, United States

Additional Information

Starting date: December 2005
Last updated: August 17, 2015

Page last updated: August 23, 2015

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