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Risedronate Reverses Bone Loss in Postmenopausal Women with Low Bone Mass: Results From a Multinational, Double-Blind, Placebo-Controlled Trial¹

Department of Nuclear Medicine (I.F.), Guy’s Hospital, London SE1 9RT, United Kingdom; Department of Endocrinology (C.R.), Hospital Rangueil, Toulouse 31403, France; Oxford Health Management Ltd. (R.S.), Acland Hospital, Oxford S10 2RX, United Kingdom; Procter & Gamble Pharmaceuticals (D.E., E.S.), Mason, Ohio 45040; and Bone/Cartilage Metabolism Unit (J.-Y.R.), Polycliniques L. Brull, 4020 Liege, Belgium

Address correspondence and requests for reprints to: Ignac Fogelman, Department of Nuclear Medicine, Guy’s Hospital, St. Thomas Street, London SE1 9RT, United Kingdom.

Our objective was to investigate the efficacy and tolerability of risedronate in postmenopausal women with low bone mass.

Women with a mean lumbar spine T-score of -2 or less (n = 543) received 24 months of placebo or risedronate (2.5 or 5 mg/day). All received calcium (1 g/day). The principal outcome measures were bone mineral density (BMD) at the lumbar spine, femoral neck, and femoral trochanter.

At 24 months, lumbar spine BMD increased from baseline by 4% with 5 mg risedronate and 1.4% in the 2.5-mg group, compared with no change with placebo. Efficacy was similar in women who were less than 5 yr and more than 5 yr postmenopausal. At 24 months, risedronate (5 mg) had also increased BMD at the femoral neck and trochanter, whereas BMD decreased in the placebo group. BMD increases were seen at all three sites with risedronate (5 mg) after only 6 months of therapy. Risedronate was well tolerated; upper gastrointestinal adverse events were similar to placebo.

We conclude that risedronate (5 mg) increases BMD rapidly and effectively and is well tolerated in postmenopausal women with low bone mass, regardless of time since menopause.

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