The effect of Ibandronate on bone density and biochemical markers of bone resorption - a clinical study with postmenopausal osteoporotic women

This clinical study, conducted in a doctor's practice, deals with the bisphosphonat Ibandronat which was given intravenously to post-menopausal women with osteoporosis before it appeared officially on the Swiss market (01.10.2006 under the brand name Bonvival (R)). The drug was applied in an "off label" form at a rheumatological practice to 71 consecutive and random patients with post-menopausal osteoporosis and who were intolerant of oral bisphosphonates. The initial dose was 2 mg every 3 months. This was adapted accordingly depending on the results of bone resorption markers. The effect of Ibandronate was evaluated in 30 patients by using bone density measurements of the lumbar spine and the hip; suppression of bone resorption was controlled by using the bone resorption markers pyridinolin and desoxypyridinolin. With regard to the change in bone density of the lumbar spine, the results were similar to those in other prospective randomized studies with the same substance (1,6% increase after one year, 2,8% after two years and 6,4% after four years). Intravenously given Ibandronate was generally well tolerated. The most frequent adverse effects were noted in the musculoskeletal system (joint pain in 16.6%), exanthema and flu-like illness. We conclude that the increase of bone density in the lumbar spine and adverse effects in patients receiving intravenous Ibandronate in our practice is comparable to the results of the extensive RCT's conducted during periods of 2 to 4 years.