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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02604836
Other study ID # ML18056
Secondary ID
Status Completed
Phase Phase 4
First received November 6, 2015
Last updated November 1, 2016
Start date June 2004
Est. completion date April 2006

Study information

Verified date November 2016
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority USA:FDA
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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).

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

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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