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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02598453
Other study ID # ML18058
Secondary ID
Status Completed
Phase Phase 4
First received November 4, 2015
Last updated November 1, 2016
Start date January 2005
Est. completion date September 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

The purpose of this study is to evaluate treatment adherence to different regimens of ibandronate in postmenopausal women with osteoporosis or osteopenia who are intolerant to daily or weekly alendronate or risedronate therapy due to gastrointestinal (GI) side effects. The anticipated time on study treatment is 12 months, and the target sample size is 517 individuals.


Recruitment information / eligibility

Status Completed
Enrollment 545
Est. completion date September 2006
Est. primary completion date September 2006
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

- Women with postmenopausal osteoporosis or osteopenia

- Discontinuation of daily and /or weekly alendronate or risedronate therapy because of GI intolerance (eg, heartburn, acid reflux, stomach upset)

Exclusion Criteria:

- Inability to stand or sit upright for 60 minutes

- Inability to swallow a tablet whole - Hypersensitivity to any component of Boniva

- Malignant disease diagnosed within previous 10 years (except resected basal cell cancer); contraindications for calcium or vitamin D therapy

- Patients who do not fulfill a minimum 3 months wash-out therapy from any previous bisphosphonate therapy

Study Design

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


Intervention

Drug:
Ibandronate
Either 150 mg oral tablet once monthly or 3 mg IV injection once every 3 months

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 Percentage of participants who have greater than or equal to (>=) 75 percent (%) adherence using either monthly oral ibandronate or quarterly intravenous (IV) ibandronate 12 months No
Secondary Percentage of participants who have an adherence of >= 75% using ibandronate including both switch and non-switch participants 12 months No
Secondary Percentage of participants with GI events based on severity Up to 10 months No
Secondary Percentage of participants who experienced a change in frequency and number of GI events Up to 10 months No
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