PRIOR Study - A Study of Ibandronate (Boniva) in Postmenopausal Women With Osteoporosis or Osteopenia

Phase 4

Completed

• Conditions: Postmenopausal Osteoporosis
• Interventions: Drug: Ibandronate

• Registration Number: NCT02598453
• Lead Sponsor: Hoffmann-La Roche

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01
• Primary Completion: 2006-09
• Study Completion: 2006-09
• Study First Submitted: 2015-11-04
• Study First Submitted QC: 2015-11-04
• Study First Posted: 2015-11-05
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 545

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ibandronate Oral	Ibandronate	Participants will receive ibandronate 150 milligrams (mg) tablet once monthly
Ibandronate IV	Ibandronate	Participants will receive ibandronate 3 mg IV once every 3 months

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Percentage of participants who have an adherence of >= 75% using ibandronate including both switch and non-switch participants	12 months
Percentage of participants with GI events based on severity	Up to 10 months
Percentage of participants who experienced a change in frequency and number of GI events	Up to 10 months