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      Effects of Teriparatide at 1 to 3 Months Predict 1- to 2-Year Effects: Presented at ENDO

      By Maggie Schwarz

      PHILADELPHIA, PA -- June 25, 2003 -- Early changes in biochemical markers of bone formation in patients taking the new osteoporosis drug teriparatide correlate with long-term changes in bone structure, according to a new study presented here on June 22nd at the Endocrine Society's 85th Annual Meeting.

      The correlation between 1 to 3 month and 1 to 2 year effects may provide an important tool to predict long term bone-building effect of the drug, said Harald Dobnig and colleagues, from the University of Graz, in Graz, Austria.

      Until recently, the only approved osteoporosis treatments were antiresorptive agents, which work mainly to slow or stop bone loss by reducing the number and action of osteoclasts.

      Teriparatide -- a recombinant human parathyroid hormone -- reverses osteoporotic changes in bone structure and has been shown to decrease fracture rates. The agent stimulates formation of new bone by increasing the number and action of osteoblasts.

      Previous research showed that bone structure, volume and strength improve after 12 to 24 months of treatment with teriparatide. The new, multicentre study by Dr. Dobnig and colleagues, performed in the U.S. and Canada as well as Austria, shows that early changes in markers of bone formation in patients taking teriparatide can predict long-term changes to bone structure.

      The researchers studied 31 paired iliac crest biopsies from patients treated with teriparatide for 12 to 24 months.

      "We discovered that patients who experienced early increases in biochemical markers of bone formation were more likely to experience improvements in bone structure during long-term teriparatide therapy," said Dr. Dobnig. "This correlation may provide us with an early tool to predict the later anabolic effects of teriparatide. Bone structure changes noted included increases in mean wall thickness and trabecular thickness, trabecular connectivity, and trabecular volume."

      A significant amount of new bone formed during teriparatide therapy seems to be formed via modelling -- that is, formation of new bone without previous resorption.

      The research was funded by Eli Lilly and Company.


      [Study title: Early Changes in Biochemical Markers of Bone Formation Predict Improvements in Bone Structure during Teriparatide Therapy. Abstract OR54-2]



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