DG DISPATCH - EULAR: Fosamax Prevents Glucocorticoid-Induced Bone Loss
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DG DISPATCH - EULAR: Fosamax Prevents Glucocorticoid-Induced Bone Loss

By David Jack
Special to DG News

GLASGOW, SCOTLAND -- June 11, 1999 -- Study results confirm that Merck’s Fosamax™ (alendronate) is an effective and well-tolerated treatment for reversing glucocorticoid-induced bone mass loss.

These results were presented on the fourth day of the XIV European League against Rheumatism (EULAR) Congress in Glasgow, Scotland.

Dr. Jonathan Adachi, department of medicine, McMaster University, and head of rheumatology, St. Josephs Hospital, Hamilton, ON., presented the latest results from a large multinational study.

A total of 560 men and women aged 18 to 80 were randomised to two, one-year, multinational studies looking at the effect of Fosamax on bone mass in patients taking glucocorticoid therapy.

In each study, one group of patients continued with their prednisone therapy greater than or equal to 7.5 mg/day and were entered in a one-year blinded extension. Patients were randomised to received oral Fosamax 5 mg/day or 10 mg/day for two years or 2.5 mg for one year switched to 10 mg in the second year or placebo.

All patients received daily supplements of calcium and vitamin D. The primary end-point was bone mineral density (BMD); secondary end-points included biochemical markers and number of fractures.

Mean percent change from baseline to month 24: lumbar spine: PBO (-0.91), ALN 5mg (2.86), ALN 10mg (3.86), ALN2.5/10mg (3.58) Femoral neck: PBO (-2.98), ALN 5mg (0.01), ALN 10 mg (0.62), ALN 2.5/10mg (-0.63) Trochanter: PBO (-1.18), ALN 5mg (2.08), ALN 10mg (3.99), ALN2.5/10mg (1.74).

Mean BMD levels at 24 months after the start of treatment were increased significantly from baseline as follows:
-- Lumbar spine changes: Fosamax 5 mg (2.86 percent); Fosamax 10 mg (3.86 percent); Fosamax 2.5/10 mg (3.58 percent); placebo (-0.91 percent).
-- Femoral neck changes: Fosamax 5 mg (0.01 percent); Fosamax 10 mg (0.62 percent); Fosamax 2.5/10 mg (-0.63 percent); placebo (-2.98 percent).
-- Trochanter changes: Fosamax 5 mg (2.08 percent); Fosamax 10 mg (3.99 percent); Fosamax 2.5/10 mg (1.74 percent); placebo (-1.18 percent).

All increases were significant relative to placebo at all sites. Bone resorption and formation fell by about 60 percent and 20 percent, respectively, in Fosamax-treated patients during the first year of treatment and remained within the normal range during the second year.

The incidence of vertebral fractures was much lower at 24 months in the pooled Fosamax group (0.7 percent) compared with the placebo group (7.0 percent).

Dr. Adachi said this study confirms that Fosamax is an effective and well-tolerated treatment in patients with glucocorticoid-induced bone loss.

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