A Study of Ibandronate (Boniva) to Evaluate Bone Turnover Markers in Women With Treatment-Naive Postmenopausal Osteoporosis

Completed · Phase 4

Conditions studied: Post Menopausal Osteoporosis

In brief

This study will evaluate whether an early positive response to once-monthly oral ibandronate in treatment-naive participants with postmenopausal osteoporosis is predictive of efficacy later in treatment. The anticipated time on study treatment is 6 months, and the target sample size is 360 individuals.

Key facts

Study ID

NCT02598934

Run by

Hoffmann-La Roche

People needed

308

Starts

2004-08-01

Expected to finish

2006-05-01

Last updated by the study team

2016-03-09

Who can join

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

You may qualify if…

• Women newly diagnosed with postmenopausal osteoporosis
• Naive to prior bisphosphonate therapy

You may not qualify if…

• Inability to stand or sit upright for at least 60 minutes
• Inability to swallow a tablet whole
• Hypersensitivity to any component of ibandronate
• Hormone (estrogen) replacement therapy within last 3 months, or will start on therapy within next 6 months
• Other osteoporosis drug within last 3 months
• Malignant disease diagnosed within previous 10 years, except resected basal cell cancer

Where it is running

• Study site — Chandler, Arizona, United States
• Study site — Peoria, Arizona, United States
• Study site — Hot Springs, Arkansas, United States
• Study site — Pine Bluff, Arkansas, United States
• Study site — Anaheim, California, United States
• Study site — Beverly Hills, California, United States
• Study site — Carmichael, California, United States
• Study site — Wilmington, Delaware, United States
• Study site — DeLand, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Palm Habor, Florida, United States
• Study site — Palm Springs, Florida, United States
• Study site — West Palm Beach, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Rome, Georgia, United States
• Study site — Morton Grove, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Waterloo, Iowa, United States
• Study site — Baltimore, Maryland, United States
• Study site — Hagerstown, Maryland, United States
• Study site — Reistertown, Maryland, United States
• Study site — Olive Branch, Mississippi, United States
• Study site — Jefferson City, Missouri, United States
• Study site — Montgomery, Alabama, United States

Full record on ClinicalTrials.gov

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