Self-injected PTH, New SERM Target Osteoporosis.

DENVER -- Emerging approaches to osteoporosis include self-injected recombinant parathyroid hormone and a new third-generation selective estrogen-receptor modifier, according to reports at the annual meeting of the Endocrine Society.

With regard to recombinant human parathyroid hormone (PTH), Dr. William H. Scheele presented new data on 1,261 postmenopausal women followed for 18 months after discontinuation of PTH or placebo following 21 months of daily self-injected therapy.

During the total 39 months of the study, the relative risk of nonvertebral fragility fractures was reduced by 48%-52% in the PTH group, depending upon the dose they were randomized to receive. Perhaps even more interesting, the benefit was maintained even after treatment stopped. During the 18-month observation period in which patients didn't take PTH, their risk of nonvertebral fragility fractures was reduced by 52%-58%, compared with those who had been on placebo. Data on vertebral fracture rates are still being compiled and will be presented later this year, said Dr. Scheele of Eli Lilly & Co., Indianapolis.

The three adverse events that were more common in the PTH group during 21 months of treatment--headache, nausea, and leg cramps--resolved during the 18-month observation period.

This was an observational study, so it couldn't address the key issues of whether combining PTH with other antiosteoporosis agents yields added benefit, or how best to manage patients once they have gone off the ...