MOBILE Study - A Study of Bonviva (Ibandronate) Regimens in Women With Post-Menopausal Osteoporosis

Status:	Completed
Conditions:	Osteoporosis, Osteoporosis
Therapuetic Areas:	Rheumatology
Healthy:	No
Age Range:	55 - 80
Updated:	4/17/2018
Start Date:	April 2002
End Date:	December 2004

Randomized, Double-blind, Double Dummy, Parallel Groups, Multicenter Study to Compare the Efficacy and Safety of Monthly Oral Administration of 100 mg and 150 mg Ibandronate With 2.5 mg Daily Oral Ibandronate in Postmenopausal Osteoporosis

This study will compare the efficacy and safety of different treatment regimens of oral
Bonviva tablets in women with post-menopausal osteoporosis. Patients will also receive daily
supplementation with vitamin D and calcium. The anticipated time of study treatment is 2+
years, and the target sample size is 500+ individuals.

Inclusion Criteria:

- women 55-80 years of age;

- post-menopausal for >= 5 years;

- ambulatory.

Exclusion Criteria:

- malignant disease diagnosed within the previous 10 years (except basal cell cancer
that has been successfully removed);

- breast cancer within the previous 20 years;

- allergy to bisphosphonates;

- previous treatment with an intravenous bisphosphonate at any time;

- previous treatment with an oral bisphosphonate within the last 6 months, >1 month of
treatment within the last year, or >3 months of treatment within the last 2 years.

We found this trial at

sites

Clinical Trial Facility in Adelaide

Adelaide,

from

Adelaide,