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Alendronate Benefits Can Persist After Withdrawal of Treatment: Presented at ASBMR

By Coriene E. Hannapel
Special to DG News

SAN ANTONIO, TX -- September 23, 2002 -­ Early post-menopausal women who receive continuous therapy with alendronate, 5 mg daily for six years, show normalized bone turnover and preserved bone density during the treatment interval. Although indices of bone turnover increase and approach baseline, and bone loss values resume when therapy is withdrawn, the bone density value in the spine remains substantially higher than the value of the placebo group, which steadily decreases.

"So there was a persistence of a difference in bone density, even four years after alendronate therapy was withdrawn after a treatment interval of two years," reported Michael R. McClung, M.D., Director, Oregon Osteoporosis Center, in the United States.

Dr. McClung presented the results of the Early Postmenopausal Interventional Cohort (EPIC) Study at the 24^th Annual Meeting of the American Society for Bone and Mineral Research Meeting held here.

Study objectives included evaluating the long-term efficacy, safety, and tolerability of oral alendronate therapy compared to placebo in young postmenopausal women. A second objective of the study was to compare the skeletal effects, both on bone density and bone turnover, with regimens of estrogen and progestin therapy, and to assess the resolution of the skeletal effects following withdrawal of these therapies, Dr. McClung said.

The EPIC study was a randomized triple blind, placebo-controlled trial involving 1,609 women who, at the time of entry, were between the ages of 45 and 59, had a mean spine bone mineral density (BMD) T-score of -0.8, and who were at least one year beyond menopause. Four distinct study sites across the world were involved. The women were randomly assigned to receive either placebo; one of two doses of alendronate, 2.5 or 5 mg daily; or to receive open label estrogen-progestin therapy for four years.

After two and four years, women who had received 5 milligrams of alendronate daily were randomly assigned to be withdrawn from therapy. These patients, as well as those on continuous therapy were followed in the study.

At the end of four years, the estrogen-progestin arm had completed the study, but the women were given the option of discontinuing estrogen and remaining in the study as an extension of the cohort.

During the study, BMD was measured at the lumbar spine, hip, forearm, and total body at baseline and then annually.

The percentage of change during years 5 and 6 was used to evaluate the results of the treatment. Women in the estrogen-progestin arm for four years had significantly greater mean BMD loses at the lumbar spine, hip sites, and forearm during years 5 and 6 than those who had received alendronate, 5 mg for four years.

Results of the study demonstrated that bone loss resumes when alendronate, 5 mg daily, is discontinued after four years but at a rate slower than that following estrogen-progestin therapy. "In contrast to withdrawal of estrogen, catch-up loss is not observed following alendronate," Dr. McClung said.

"BMD at the end of six years remained significantly higher in women who previously received alendronate 5 mg for four years than in those who were never treated with alendronate," Dr. McClung said.

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