Eli Lilly and Company

Analysis Shows Teriparatide Reduces Fracture Risk Independent of Bone Turnover

    Indianapolis (ots/PRNewswire) - Data presented at the 26th annual meeting of the American Society for Bone and Mineral Research (ASBMR), Seattle, Wash., shows that the ability of teriparatide to prevent fractures remained consistent regardless of pretreatment bone turnover status.(1)

    Bone is living tissue that constantly regenerates itself by breaking down and reforming, a process referred to as bone turnover. Osteoporosis can occur when bone breakdown exceeds bone formation.

    "In most cases, rapid bone turnover can be dangerous and lead to fracture in osteoporotic patients," said the study's primary investigator, Pierre Delmas, M.D., Claude Bernard University of Lyon, France. "In this study, regardless of whether patients had high turnover rates before being treated, we saw a reduced risk of fractures with teriparatide."

    This posthoc analysis examined biochemical markers of bone turnover, which provide information about the rate of bone turnover. This rate can vary considerably in postmenopausal women with osteoporosis. In this study, the impact of the pretreatment bone turnover rate on the response to teriparatide was examined.(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 whether rate of bone turnover has an impact on the effect of teriparatide, this analysis looked at the relationship between baseline biochemical markers of bone turnover and the ability of teriparatide to reduce the occurrence of fractures.(1)

    Five biochemical markers from postmenopausal women with osteoporosis who participated in the pivotal Forteo Fracture Prevention Trial were analyzed.(1)

    The Fracture Prevention Trial (FPT), a registration trial for Forteo, was a randomized, double-blinded, placebo-controlled study that enrolled 1,637 women with osteoporosis. Subjects were randomized to teriparatide 20 micrograms/day (marketed as Forteo), teriparatide 40 micrograms/day or placebo for a median of 19 months.(1)

    A subset of 520 women had biochemical markers of bone turnover (serum bone-specific alkaline phosphatase [BSAP], serum carboxy-terminal extension peptide of procollagen type 1 [PICP], urinary N-terminal telopeptide [NTX and urinary free deoxypyridinoline [DPD]) measured at baseline. A partially overlapping subset of 771 women also had serum amino-terminal extension of peptide of procollagen type 1 [PINP] evaluated at baseline. BSAP, PICP and PINP are all markers of bone formation, whereas DPD and NTX are markers of bone resorption.(1)

    Analysis found that subjects with higher baseline concentrations of BSAP, PINP, NTX and DPD had a higher risk of a new fragility fracture. Teriparatide significantly reduced the risk of vertebral and nonvertebral fragility fractures regardless of pretreatment bone turnover, according to study results.(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.

@@start.t1@@      References
      1. Delmas et al. Fracture Risk Reduction During Treatment with
          Teriparatide is Independent of Pretreatment Bone Turnover 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

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