Postmenopausal Osteoporosis Clinical Trial
Official title:
A Prospective, Open-Label, Multi-Center, Two-Part Study to Investigate Patient Satisfaction With Monthly Dosed Ibandronate Therapy in Women With Post-Menopausal Osteoporosis or Osteopenia Transitioned From Once-Weekly Alendronate or Risendronate
Verified date | November 2016 |
Source | Hoffmann-La Roche |
Contact | n/a |
Is FDA regulated | No |
Health authority | USA:FDA |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1711 |
Est. completion date | April 2006 |
Est. primary completion date | April 2006 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
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). |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hoffmann-La Roche |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Part A: Number of participants who currently use weekly biphosphonate who answer "yes" to any of the questions in Candidate Identification Questionnaire (CIQ) | Up to 30 days prior to baseline visit | No | |
Primary | Part B: Number of participants who demonstrate improvement from their baseline satisfaction score after 6 months of ibandronate | 6 months | No | |
Primary | Part B: Percentage of participants who demonstrate improvement from their baseline satisfaction score after 6 months of ibandronate | 6 months | No | |
Secondary | Part B: Percentage of eligible weekly biphosphonate users at screening who elect to enter Part B | Screening visit | No | |
Secondary | Part B: Percentage of participants who report an improved satisfaction score with monthly ibandronate compared to weekly alendronate or risendronate | 6 months | No | |
Secondary | Part B: Percentage of participants who report preference to monthly ibandronate or weekly alendronate or risedronate | 6 months | No | |
Secondary | Part B: Percentage of participants who have greater than or equal to (>=) 80 percent (%) compliance | 6 months | No | |
Secondary | Part B: Percentage of participants who report an improvement in the gastrointestinal (GI) symptoms | 6 months | No | |
Secondary | Part B: Percentage of participants by age and activity level who report high satisfaction according to Osteoporosis Patient Survey satisfaction Questionnaire (OPSAT-Q) | 6 months | No | |
Secondary | Part B: Individual Domain scores from Osteoporosis Patient Survey satisfaction Questionnaire (OPSAT-Q) | Baseline and 6 months | No | |
Secondary | Part B: Number of eligible weekly biphosphonate users at screening who elect to enter Part B | Screening Visit | No | |
Secondary | Part B: Number of participants who report an improved satisfaction score with monthly ibandronate compared to weekly alendronate or risendronate | 6 months | No | |
Secondary | Part B: Number of participants who report preference to monthly ibandronate or weekly alendronate or risedronate | 6 months | No | |
Secondary | Part B: Number of participants who have >= 80% compliance | 6 months | No | |
Secondary | Part B: Number of participants who report an improvement in the GI symptoms | 6 months | No | |
Secondary | Part B: Number of participants by age and activity level who report high satisfaction according to Osteoporosis Patient Survey satisfaction Questionnaire (OPSAT-Q) | 6 months | No |
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