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Teriparatide Tops Alendronate in Multiple Subgroups at Increased Fracture Risk: Presented at EULAR

By Jill Stein

PARIS -- June 13, 2008 -- Teriparatide is more effective than alendronate in increasing lumbar spine density in premenopausal and postmenopausal women and in men with glucocorticoid-induced osteoporosis at increased risk of fracture, according to research presented here at EULAR 2008, the Annual Congress of the European League Against Rheumatism.

Glucocorticoid-induced osteoporosis is a leading cause of secondary osteoporosis.

Fernando Marin, PhD, Lilly Research Laboratories, Alcobendas, Spain, and colleagues conducted post hoc analyses to describe areal bone mineral density (BMD) changes, fracture incidence, and safety in men and in premenopausal and postmenopausal women with glucocorticoid-induced osteoporosis.

There has been variable efficacy of bisphosphonate interventions for the treatment of glucocorticoid-induced osteoporosis in subgroups of patients, and further study is needed to optimise the management of glucocorticoid-induced osteoporosis.

The trial, presented on June 13, included 428 patients taking prednisone equivalent to at least 5 mg/day for 3 months or longer.

Subjects were randomised to 18 months of daily treatment with teriparatide 20 mcg or alendronate 10 mg.

The percent change in lumbar spine BMD was significantly greater with teriparatide compared with alendronate treatment in postmenopausal women, premenopausal women, and men.

Results show a significantly greater percent change in total hip BMD with teriparatide compared with alendronate in premenopausal women.

There were fewer incident vertebral fractures in the teriparatide compared with the alendronate group (0.6% vs 6.1%, P = .005). Rates were 0.6% and 3.6%, respectively, for postmenopausal women (P = .12); 0% and 0% for premenopausal women; and 0% and 2.4% for men (P = .113).

There was no significant difference between teriparatide and alendronate in the number of patients with new nonvertebral fractures (5.6% vs 3.7%, P = .493). Overall, 4.9% of postmenopausal women in the teriparatide group had new nonvertebral fractures versus 2.8% of postmenopausal women treated with alendronate (P = .430). The figures were 0.9% and 0% for premenopausal women, and 0.5% and 0.9% for men (P = .498 and P = .616).

There were no statistically significant interaction effects between treatment groups and subgroups in BMD and fracture analyses (P < .658).

Treatment-related adverse-event profiles were generally consistent across subgroups, with nausea occurring in more teriparatide than alendronate patients in each subgroup.

Overall, the findings indicated that the anabolic agent teriparatide is more effective than the antiresorptive agent alendronate in increasing lumbar spine BMD, the authors concluded.


[Presentation title: Teriparatide Versus Alendronate in Glucocorticoid-Induced Osteoporosis: Results of a Subgroup Analysis in Men, Pre- and Postmenopausal Women. Abstract FRI0387]

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