A Study of Ibandronate (Boniva) to Evaluate Satisfaction in Women With Post-Menopausal Osteoporosis or Osteopenia

Hoffmann-La Roche1,711 enrolled

Overview

This study will investigate participant satisfaction (including compliance, preference, tolerability) with once-monthly Bonviva in women with post-menopausal osteoporosis or osteopenia transitioned from once-weekly alendronate or risedronate. The anticipated time on study treatment is 6 months, and the target sample size is 1776 individuals.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,711

Conditions

Postmenopausal Osteoporosis

Interventions

IbandronateDRUG

Film-coated oral ibandronate tablet (150 mg) once-monthly

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

Inclusion Criteria: \- Women who had been receiving once-weekly alendronate or risedronate for treatment or prevention of post-menopausal osteoporosis for greater than or equal to (\>=) 3 months Exclusion Criteria: * Inability to stand or sit upright for \>=60 minutes * Hypersensitivity to bisphosphonates * Inability to swallow a tablet whole * Malignant disease diagnosed within previous 10 years (except resected basal cell cancer).

Locations (142)

Outcomes

Primary Outcomes

Part A: Number of participants who currently use weekly biphosphonate who answer "yes" to any of the questions in Candidate Identification Questionnaire (CIQ)

Time frame: Up to 30 days prior to baseline visit

Part B: Number of participants who demonstrate improvement from their baseline satisfaction score after 6 months of ibandronate

Time frame: 6 months

Part B: Percentage of participants who demonstrate improvement from their baseline satisfaction score after 6 months of ibandronate

Time frame: 6 months

Secondary Outcomes

Part B: Percentage of eligible weekly biphosphonate users at screening who elect to enter Part B

Time frame: Screening visit

Part B: Percentage of participants who report an improved satisfaction score with monthly ibandronate compared to weekly alendronate or risendronate

Time frame: 6 months

Part B: Percentage of participants who report preference to monthly ibandronate or weekly alendronate or risedronate

Time frame: 6 months

Part B: Percentage of participants who have greater than or equal to (>=) 80 percent (%) compliance

Time frame: 6 months

Part B: Percentage of participants who report an improvement in the gastrointestinal (GI) symptoms

Time frame: 6 months

Part B: Percentage of participants by age and activity level who report high satisfaction according to Osteoporosis Patient Survey satisfaction Questionnaire (OPSAT-Q)

Data from ClinicalTrials.gov

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Birmingham, Alabama, United States

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Columbiana, Alabama, United States

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Huntsville, Alabama, United States

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Mobile, Alabama, United States

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Montgomery, Alabama, United States

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Chandler, Arizona, United States

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Gilbert, Arizona, United States

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Paradise Valley, Arizona, United States

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Phoenix, Arizona, United States

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Phoenix, Arizona, United States

...and 132 more locations