A Study of Bone Turnover Markers in Post-Menopausal Women With Osteoporosis Treated With Monthly Boniva (Ibandronate)

A Randomized, Double-blind, Placebo-controlled Study to Determine Time to Onset of Suppression of the Bone Resorption Marker sCTX With Once Monthly Ibandronate in the Treatment of Postmenopausal Osteoporosis

This study will determine the rapidity of suppression of the bone resorption marker sCTX in post-menopausal women with osteoporosis.Other bone turnover markers will also be evaluated. Patients will be randomised to either monthly Boniva 150mg or placebo, in combination with vitamin D and calcium supplementation. The anticipated time on study treatment is approximately 7 months, and the target sample size is <100 individuals.

Inclusion Criteria:

• women who have been newly diagnosed with post-menopausal osteoporosis, requiring treatment;
• naive to bisphosphonate treatment,or had bisphosphonate treatment for a maximum of 3 months, at least 5 years before screening.

Exclusion Criteria:

• patients on hormone replacement therapy (HRT) within the last 3 months;
• patients on other osteoporosis medication within the last 3 months;
• sCTX below lower limit, or above 3 times the upper limit, of normal premenopausal level;
• hypersensitivity to any component of ibandronate;
• contraindication for calcium or vitamin D therapy;
• history of major gastrointestinal upset;
• malignant disease diagnosed within the previous 10 years (except resected basal cell cancer).