EVISTA improves bone quality as measured by HRpQCT: IIT

- 3D Images Provide New Approach to Monitoring Bone Changes

Interim data from a prospective Investigator Initiated Trial (IIT) presented today at the ECTS, the 37th European Symposium on Calcified Tissues, in Glasgow, demonstrates that EVISTA(R) (raloxifene 60mg; once-daily, distributed in 34 countries by DAIICHI SANKYO), indicated for the treatment and prevention of osteoporosis in postmenopausal women, improves bone quality as measured by the high-resolution peripheral quantitative computed tomography (HRpQCT). Dr. Radspieler, Investigator of the IIT at the Osteoporosis Diagnostic- und Therapy centre Munich, evaluated prospectively micro-architectural changes of the bone of patients being treated with EVISTA(R) for 15.1 months. The trial showed that, all parameters analysed improved over the treatment period. Exemplary, raloxifene increased volumetric trabecular by 2.9% and 3.9% and cortical bone densities by 1.1% and 0.7% in the radius and the tibia respectively.

Dr. Helmut Radspieler comments: "With the help of 3D images we can now actually see into the micro-structure of bones. This makes it possible to determine the efficacy of different treatments, as shown here with raloxifene." He continues; "We now understand better and are also able to visualise that bone structure and not bone density alone is crucial to retain bone quality".

Bone mineral density (BMD) assessed by dual-energy X-ray absorptiometry (DXA) is the current gold standard for the diagnosis of osteoporosis, however, it is not as effective in the measurement of the therapeutic effect of an osteoporosis treatment. By using a new three-dimensional imaging technique called HRpQCT researchers were able to look inside the bone at the specific bone structure and quality. This provides a new approach to monitoring bone changes, especially while being treated medically for osteoporosis.

It was shown in clinical studies that raloxifene significantly increased BMD by 2% in both osteopenic and osteoporotic postmenopausal women compared to placebo. Compared with other osteoporotic drugs the numeric BMD increase with raloxifene is relatively low, although the vertebral fracture risk reduction is similar. The MORE (Multiple Outcome of Raloxifene Evaluation) study demonstrated that EVISTA(R) had a 55% relative risk reduction of vertebral fractures vs. placebo with a 2.4% absolute risk reduction in the risk of 1st vertebral fracture in patients with osteoporosis over 3 years. In addition, even the population of patients who lost BMD in the MORE study demonstrated a fracture risk reduction. Taking into account that bone strength is determined by both bone density and bone quality, it is assumed that less than 4% of fracture risk reduction is correlated to BMD after raloxifene treatment.