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

Study Overview
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Brief Summary
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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.

Official Title
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An Open-Label, Multi-Center Study to Determine Level of Adherence to Monthly Oral or Every Three Month Intravenous Ibandronate Treatment in Post-Menopausal Women With Osteoporosis or Osteopenia, Who Are GI Intolerant of Daily or Weekly Alendronate or Risendronate

Conditions
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Postmenopausal Osteoporosis

Intervention / Treatment
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* Drug: Ibandronate


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ibandronate IV<br>Participants will receive ibandronate 3 mg IV once every 3 months | Drug: Ibandronate<br>* Either 150 mg oral tablet once monthly or 3 mg IV injection once every 3 months<br>* Other names: Bonviva/Boniva;|
| Experimental: Ibandronate Oral<br>Participants will receive ibandronate 150 milligrams (mg) tablet once monthly | Drug: Ibandronate<br>* Either 150 mg oral tablet once monthly or 3 mg IV injection once every 3 months<br>* Other names: Bonviva/Boniva;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |