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Forteo Appears Safe and Effective for Treating Postmenopausal Women Over 75 Years With Osteoporosis: Presented at AGS

By Jerry Ingram

ORLANDO, FL -- May 16, 2005 -- Teriparatide (Forteo) appears to be safe and effective for treating older women with severe osteoporosis, researchers said here at the American Geriatric Society Annual Meeting.

"We were interested in looking at whether women over the age 75 who have severe osteoporosis would respond to [Forteo] the same as those under 75," said John H. Krege, MD, research physician, Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana, United States.

"In our study, the women over 75 years of age did just as well, if not better than the younger women," Dr. Krege said during a poster session here on May 13^th.

Dr. Krege and associates analysed data from the Fracture Prevention Trial (FPT), a randomised, multicentre, double-blind placebo-controlled trial that examined the efficacy and safety of teriparatide for treating osteoporosis in postmenopausal women.

That study had randomised 541 women to self-administered injections of teriparatide 20 mcg/day, 552 women to teriparatide 40 mcg/day, and 544 women to placebo for a median of 19 months.

For their analysis, Dr. Krege and his team collected data on 1085 women in the trial, singling out 244 who were at least 75 years old and 841 who were younger.

They examined only data on women who received 20 mcg and the placebo group. Additionally, women in the study received daily oral supplementation of calcium (1000 mg) and vitamin D (400-1200 IU).

Dr. Krege's team assessed bone mineral density of lumbar spine and femoral neck both at baseline and at conclusion of the study, using dual-energy X-ray absorptiometry (DXA), the gold standard for bone mineral density (BMD) evaluation. In addition, they performed radiographs of the spine and questioned patients regarding non-vertebral fractures. They also documented any patient report of adverse events after starting of the study drug.

The data were analysed by subgroups according to age, using one-way analyses of variance (ANOVA) to highlight differences between treatment groups within each age group.

Results of the analysis show little difference in treatment-by-age interaction for the bone turnover markers, femoral neck BMD, vertebral fractures, and non-vertebral fragility fractures. Older patients responded the same to treatment on all efficacy measures except lumbar spine BMD (interaction P = .075).

There were no differences in terms of what researchers regard as the most important treatment-emergent adverse events, such as back pain, nausea, leg cramps and dizziness (P < .1), Dr. Krege said.

[Presentation title: Safety and Efficacy of Teriparatide [Forteo, rhPTH (1-34)] in Elderly Women with Osteoporosis. Abstract B25]

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