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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02598453

Enrollment

545

Registered

2015-11-05

Start date

2005-01-31

Completion date

2006-09-30

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postmenopausal Osteoporosis

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.

Interventions

DRUGIbandronate

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Measure	Time frame
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
Percentage of participants who have an adherence of >= 75% using ibandronate including both switch and non-switch participants	12 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026