Overview

A Study To Assess The Quality Of Bone In Patients Taking Oral Ibandronate Versus Placebo

Status:
Completed
Trial end date:
2007-07-01
Target enrollment:
0
Participant gender:
Female
Summary
The purpose of this study is to estimate the effect of oral Boniva (ibandronate sodium)taken once monthly versus placebo on bone quality and strength at the hip at one year.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
GlaxoSmithKline
Treatments:
Diphosphonates
Ibandronic Acid
Criteria
Inclusion criteria:

- Ambulatory, postmenopausal women who are diagnosed with osteoporosis.

- Must be able to stand or sit upright for at least 60 minutes and swallow a tablet
whole.

Exclusion criteria:

- Have been treated with other bisphosphonates or using chronic steroids within the past
6 months.

- Have a history of major upper GI diseases or have severe kidney dysfunction.

- Have a spine fracture (identified on x-ray).