Abstract View
S20-2
MAINTENANCE OF REDUCTION IN NON-TRAUMATIC, NON-VERTEBRAL FRACTURES 6 MONTHS AFTER DISCONTINUATION OF LY333334 [RECOMBINANT HUMAN PARATHYROID HORMONE (1-34), RHPTH(1-34)] USE IN POSTMENOPAUSAL WOMEN WITH OSTEOPOROSIS
R Lindsay1, WH Scheele2, AD Clancy2, B Mitlak2
1 Helen Hayes Hospital, West Haverstraw, New York , 2 Eli Lilly and Company, Indianapolis, Indiana
In a controlled clinical trial, parathyroid hormone (1-34) (PTH), was shown to significantly reduce both vertebral and non-traumatic, non-vertebral fractures by 65-69% and 53-54% respectively, in women with one or more vertebral fractures (19 month median PTH exposure). PTH was associated with statistically significant increases in bone mineral density in the lumbar spine (9.7-13.7%) and total hip (2.6-3.6%), and total body bone mineral content (1.3-2.3%). The present study seeks to determine whether these fracture effects persist when PTH is discontinued. Of the original study population, 77% or 1261 women volunteered for the observation study; former placebo, n=413; former PTH20, n=436; former PTH40, n=412. All women remained on calcium (1000 mg/day) and 400-1200 IU of vitamin D. Approximately one-third of participants reported use of other forms of osteoporosis therapy after discontinuation of PTH (36%, 31%, 29% for placebo, PTH20, PTH40, respectively). During the 6-month observation period, there were no statistically significant changes in femoral neck or total body bone density. Seventeen women had non-traumatic non-vertebral fractures (1.4%): placebo, n=10 (2.4%); PTH20, n=3 (0.7%); PTH40, n=4 (1.0%) (P=0.066). A Kaplan-Meier analysis of time from the original baseline to first non-traumatic non-vertebral fracture demonstrated the persistence of a statistically significant PTH effect. From baseline of the original study, 62 women reported fractures (4.9%): placebo, n=35 (8.5%); PTH20, n=14 (3.2%); PTH40, n=13, 3.2% (P=0.001). This was statistically significant for each dose compared to placebo. In conclusion, the positive effects of parathyroid hormone (1-34) in reducing the cumulative proportion of women with non-traumatic, non-vertebral fractures compared to placebo continued to be significant 6 months after discontinuation of treatment.
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