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| |  Postmenopausal Women With Severe Osteoporosis Achieve Reduced Back Pain With Teriparatide: Presented at ASBMR By Louise Gagnon MONTREAL -- September 14, 2008 -- Postmenopausal women with severe osteoporosis experienced diminished back pain when treated with teriparatide, a bone anabolic drug, according to 18-month prospective data from the European Forsteo Observational Study (EFOS), presented here at the American Society for Bone and Mineral Research (ASBMR) 30th Annual Meeting. The study of 1,648 women examined a total of 168 fractures sustained in 138 women (8.8% of the total study population) who received an injection of teriparatide, representing a fracture incidence of 821 fractures per 10,000 patient years. "This population as a group … experienced less back pain, and those with fewer fractures had even less back pain," said principal investigator Fernando Marin, MD, PhD, Lilly Research Centre, Windlesham, Surrey, United Kingdom, speaking here at a poster session on September 14. Of the fractures that the women sustained, 38.7% were clinical vertebral fractures and 61.3% were nonvertebral fractures. Back pain was evaluated with 2 tools: a 100-mm Visual Analogue Scale (VAS) ranging from no back pain (0) to worst possible back pain (100). In addition, patients responded to a questionnaire that captured the severity and frequency of back pain. "Most of the patients who entered the study had severe back pain at baseline," explained Dr. Marin. "These are very sick patients with severe osteoporosis, and they also had a lot of baseline fractures and a lot of risk factors for further fractures." A minority of patients indicated at baseline that they spent days in bed due to their back pain. At the 18-month mark, a decrease in back pain occurred in women both with and without incident fracture. Patients without incident fracture, however, experienced a greater reduction in back pain compared to those with incident fracture (-27 mm vs -18.5 mm, respectively; P < .001). "The longer we treat patients, the [fewer] fractures occur over time, and this is correlated with back pain," explained Dr. Marin. Results on adverse events with teriparatide therapy were not recorded in this particular study, noted Dr. Marin, adding that EFOS did examine health-related quality-of-life measurements in the same patient population. "We will observe what happens to [study] patients after they have stopped treatment in the next 18 months," concluded Dr. Marin. "This study will continue for more than 3 years." Funding for this study was provided by Lilly Research Laboratories. <i>[Presentation title: Back Pain Is Reduced in Postmenopausal Women With Severe Osteoporosis Treated With rhPTH (1-34) (Teriparatide) Regardless of Incident Fractures: 18 Month Results From the European Forsteo Observational Study. Abstract su413]
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