A Study of Ibandronate (Bonviva) in Patients With Post-Menopausal Osteoporosis

Hoffmann-La Roche341 enrolled

Overview

This study will evaluate participant-reported preference for either ibandronate or a comparator drug in women with postmenopausal osteoporosis. The anticipated time of study treatment is 6 months, and the target sample size is 338 individuals.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

341

Conditions

Postmenopausal Osteoporosis

Interventions

AlendronateDRUG

Participants wil receive once-weekly oral alendronate (70 mg tablet)

IbandronateDRUG

Participants wil receive once-monthly oral ibandronate (150 mg tablet)

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

Inclusion Criteria: * Ambulatory women * Diagnosis of post-menopausal osteoporosis * Women who have never received bisphosphonate therapy, or who have discontinued daily bisphosphonates at least 3 months prior to study entry Exclusion Criteria: * Inability to stand or sit in the upright position for greater than or equal to 60 minutes * Allergy to bisphosphonates; * Previous or current treatment with weekly or monthly bisphosphonates, or daily bisphosphonates for the last 3 months prior to study entry

Locations (54)

Outcomes

Primary Outcomes

Percentage of participants preferring once-monthly dosing of ibandronate over once-weekly dosing of alendronate

Time frame: Up to 6 months

Secondary Outcomes

Percentage of participants perceiving the once-monthly dosing of ibandronate to be more convenient over once-weekly dosing of alendronate.

Time frame: Up to 6 months

Incidence of adverse events

Time frame: Up to approximately 1 year

Data from ClinicalTrials.gov

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Unnamed facility

Huntsville, Alabama, United States

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Phoenix, Arizona, United States

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Tempe, Arizona, United States

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Laguna Woods, California, United States

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Mission Viejo, California, United States

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Oceanside, California, United States

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San Diego, California, United States

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San Diego, California, United States

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Santa Clarita, California, United States

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Upland, California, United States

...and 44 more locations