Overview

A Study of Bonviva/Boniva (Ibandronate) in Biphosphonate-Naïve Women With Post-Menopausal Osteoporosis

Status:
Completed
Trial end date:
2014-07-01
Target enrollment:
0
Participant gender:
Female
Summary
This single arm, open label study will assess the efficacy and safety of and compliance to treatment with Bonviva/Boniva (ibandronate) in biphosphonate-naïve patients with post-menopausal osteoporosis. Patients will receive Bonviva/Boniva at a dose of 3 mg intravenously every three months. Anticipated time on study treatment is 12 months with a follow-up of 12 months.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hoffmann-La Roche
Treatments:
Diphosphonates
Ibandronic Acid
Criteria
Inclusion Criteria:

- Female patients, > 50 years of age

- Diagnosed osteoporosis

- Bone mineral density < minus 2.5 SD or osteoporotic fracture

- At least 3 years after menopause

Exclusion Criteria:

- Impaired renal function

- Contra-indication to Calcium or Vitamin D therapy

- Previous or current treatment with biphosphonates