Risedronate Once A Week

Authors: White N.J.; Perry C.M.

Source: Treatments in Endocrinology, Volume 2, Number 6, 2003 , pp. 415-420(6)

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Abstract:

Risedronate (risedronic acid), an orally administered pyridinyl bisphosphonate, inhibits osteoclast-mediated resorption of bone and modulates bone metabolism in women with postmenopausal osteoporosis. The long terminal exponential half-life of risedronate (480 hours) has led to the development of a 35mg tablet for once-a-week administration.

The beneficial effects of risedronate 35mg once a week on total hip, femoral neck and trochanter bone mineral density (BMD) at 12 months were similar to those of risedronate 5mg once daily.

Risedronate 35mg once a week was as effective as risedronate 5mg once daily in improving lumbar spine BMD in a randomized, double-blind, multicenter trial of 1456 women with postmenopausal osteoporosis. Mean percentage increases in BMD from baseline at 12 months were 3.94% and 4.25% in the 35mg and 50mg once-a-week dose groups, compared with 4% in the 5mg once-daily dose group. The differences between the once-a-week doses and the once-daily dose met the predetermined criterion for non-inferiority.

An historical analysis suggested that risedronate 35mg once a week reduced the incidence of vertebral fracture significantly more than placebo.

The tolerability profile (including the incidence of upper gastrointestinal adverse events) of risedronate 35mg once a week in women with postmenopausal osteoporosis, was similar to that of risedronate 5mg once daily.

Keywords: Adis Drug Profiles; Risedronic acid, therapeutic use; Risedronic acid, pharmacodynamics; Risedronic acid, pharmacokinetics; Postmenopausal osteoporosis, treatment

Document Type: Research article

Affiliations: 1: Adis International Inc., Yardley, Pennsylvania, USA

Publication date: 2003-01-01