Eli Lilly and Company

Number, Severity of Fractures Predict Future Risk

    Indianapolis (ots/PRNewswire) -

    - New Analysis Showed Teriparatide Prevented Fracture Risk Associated with Increasing Number, Severity of Osteoporotic Fractures

    Data presented at the American Society for Bone and Mineral Research (ASBMR) 26th annual meeting in Seattle, Wash., showed that the number and severity of prior fractures are strong predictors of future fractures in postmenopausal women with osteoporosis and that Forteo(R) (teriparatide [rDNA origin] injection), offered patients protection against this risk.(1)

    This new analysis of the Fracture Prevention Trial, (initial results published in the New England Journal of Medicine, May 2001) included a subgroup of 931 postmenopausal women with established osteoporosis who were given placebo or teriparatide 20 micrograms. Patients in the placebo arm who had an increasing number or severity of prior fractures had increasing risk for new vertebral (spine) fractures and for new nonvertebral fragility fractures during the study. These trends were not observed in women treated with teriparatide.(1)

    Forteo(R) (teriparatide [rDNA origin] injection), the first and only bone formation agent approved for the treatment of osteoporosis, received FDA approval in November 2002 and was granted European Union (EU) approval in June 2003 and marketed there as Forsteo(R). It stimulates new bone formation by increasing the number and activity of bone-forming cells called osteoblasts. In the EU, Forsteo is licensed for the treatment of established osteoporosis in postmenopausal women who are at high risk of fracture at 20 micrograms, once daily for 18 months by subcutaneous injection.

    Until the approval of Forteo, the only approved osteoporosis treatments were antiresorptives, which work mainly to slow or stop bone loss by reducing the number and action of bone-removing cells called osteoclasts. Following cessation of Forteo therapy, patients may be continued on antiresorptive therapy.

    How Forteo Works

    The mechanism by which bone is constantly renewed is called bone remodeling. Forteo, a fragment of the natural parathyroid hormone protein found in the body, acts in a novel way on the bone remodeling process so that new bone is generated and added to the skeleton faster than old bone is broken down. This anabolic action occurs when Forteo is administered once daily and is in contrast to current osteoporosis treatments that only work to slow or stop bone loss. By acting in this novel way, Forteo increases bone strength and significantly reduces fracture risk.(2)

    About the Analysis

    To determine the relationship between baseline fracture history and future fracture risk, spine radiographs of 931 postmenopausal women with vertebral fractures were evaluated at baseline (beginning of the study) and after an average of 21 months. Additionally, the number of prior nonvertebral fractures was collected, and new nonvertebral fractures occurring during the trial were tabulated.(1)

    Findings showed that, in the placebo group, an increasing number and severity of prior vertebral and nonvertebral osteoporotic fractures were associated with a significant increase in new fracture risk. In women with mild, moderate and severe vertebral fractures at study entry, the risk for vertebral fracture during the study was 9.6 percent, 12.9 percent, and 28.4 percent, respectively. Additionally, in women with zero, one and two or more prior nonvertebral fractures at study entry, the risk for new nonvertebral fractures was 3.6 percent, 8.2 percent, and 18 percent, respectively.(1)

    These significant trends for escalating risk of new fractures in women with increasing prior fracture burden were not observed in women treated with Forsteo.(1)

    Side Effect Profile

    In studies with teriparatide, the most frequent treatment-related adverse events were generally mild to moderate, dose related and did not differ statistically from placebo. The most frequently reported symptoms were nausea, arm and leg pain, headache and dizziness.

    Development of this investigational drug was suspended in December 1998 to evaluate a carcinogenicity study in rodents. In the study, rats exposed to near-lifetime treatment with teriparatide developed bone tumors, including osteosarcomas. No bone tumors occurred in human patients in the clinical trials. A comprehensive assessment by external oncology experts and company researchers indicated that the finding in rats was unlikely to predict an increased risk of osteosarcoma for humans receiving teriparatide for the intended clinical use. This conclusion was based, in part, on several important differences between rat and human bone biology and responses to teriparatide.

    A Critical Need

    Osteoporosis is a global problem, affecting more than 150 million people worldwide. One in three postmenopausal women will be affected by osteoporosis,(3) and as the population of the world both grows and ages, it is becoming an increasingly significant cause of mortality and morbidity.(4) Studies suggest that osteoporosis may be a quickly progressing disease once a fracture occurs. The accumulation of multiple spinal fractures may result in pain, height loss, deformity, functional limitations and diminished quality of life.(5) The condition costs national treasuries in the EU more than EUR4.8 billion annually in hospital health care alone.(3)

    Lilly is committed to providing "Answers that Matter" to address the unmet needs of women at risk for or diagnosed with osteoporosis. In fact, Lilly is also responsible for developing and making available Evista(R), the first selective estrogen receptor modulator (SERM) for the prevention and treatment of osteoporosis in postmenopausal women.

    About Lilly

    Lilly, a leading innovation-driven corporation, is developing a growing portfolio of best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers -- through medicines and information -- for some of the world's most urgent medical needs.

      References
      (1)      Krege et al. Teriparatide Prevents the Fracture Risk
                 Associated with Increasing Number and Severity of
                 Osteoporotic Fractures Abstract presented at the 26th
                 American Society for Bone and Mineral Research (ASBMR)
                 Meeting, October 1-5, 2004, Seattle, Washington, USA
      (2)      Forsteo Summary of Product Characteristics
      (3)      International Osteoporosis Foundation "Call to Action"
                 Report 2001
      (4)      International Osteoporosis Foundation Annual Report 1998
      (5)      Boning Up on Osteoporosis: A Guide to Prevention and
                 Treatment. National Osteoporosis Foundation; 2000
                 SPECIFICS OF THIS DOCUMENT MUST BE REVIEWED BY LOCAL
            MEDICAL/REGULATORY/LEGAL PROCESS TO REFLECT ACCEPTABLE DATA
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