NCT02598453

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 545 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Postmenopausal Osteoporosis

Interventions

Type	Name	Description
DRUG	Ibandronate	Either 150 mg oral tablet once monthly or 3 mg IV injection once every 3 months

Timeline

• Start date: 2005-01-01
• Primary completion: 2006-09-01
• Completion: 2006-09-01
• First posted: 2015-11-05
• Last updated: 2016-11-02

Locations

60 sites across 1 country: United States