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

Completed · Phase 4

Conditions studied: Postmenopausal Osteoporosis

In brief

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.

Key facts

Study ID

NCT02598453

Run by

Hoffmann-La Roche

People needed

545

Starts

2005-01-01

Expected to finish

2006-09-01

Last updated by the study team

2016-11-02

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Study site — Lake Havasu City, Arizona, United States
• Study site — Paradise Valley, Arizona, United States
• Study site — Pine Bluff, Arkansas, United States
• Study site — San Diego, California, United States
• Study site — San Diego, California, United States
• Study site — Santa Monica, California, United States
• Study site — Tacoma, California, United States
• Study site — Vista, California, United States
• Study site — Beverly Hills, Florida, United States
• Study site — Fort Myers, Florida, United States
• Study site — Gainesville, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Ocala, Florida, United States
• Study site — Palm Harbor, Florida, United States
• Study site — West Palm Beach, Florida, United States
• Study site — Augusta, Georgia, United States
• Study site — Coeur d'Alene, Idaho, United States
• Study site — Champaign, Illinois, United States
• Study site — Evansville, Indiana, United States
• Study site — Natchitoches, Louisiana, United States
• Study site — South Portland, Maine, United States
• Study site — Detroit, Michigan, United States
• Study site — Detroit, Michigan, United States
• Study site — Chaska, Minnesota, United States
• Study site — Montgomery, Alabama, United States

Full record on ClinicalTrials.gov

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