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Title: Long-Term Alendronate Appears Beneficial for Postmenopausal Women with Osteoporosis

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N Engl J Med 2004;350:1189-99.
03/18/2004 11:36:00 AM
By Joene Hendry

A 10-year daily regimen of alendronate for the treatment of osteoporosis is associated with increased bone mineral density and appears to have no adverse cumulative effect in postmenopausal women. The Alendronate Phase III Osteoporosis Treatment Study Group initiated a pair of identical 3-year randomised, placebo controlled trials designed to permit pooling of results from 994 postmenopausal women with osteoporosis who received either 5 mg, 10mg, or 20 mg oral alendronate, or placebo. Henry G. Bone, MD, Michigan Bone and Mineral Clinic, Detroit, United States, and colleagues report the results from 247 women who participated in 4 phases of the original trials; 86 women who took 10 mg alendronate daily for 10 years, 78 women who took 5 mg alendronate for 10 years, and 83 women, the discontinuation group, assigned to placebo for 5 years after taking alendronate at dosages of 20 mg daily for 2 years and 5 mg daily for 3 years. The study population also received 500 mg calcium daily and were permitted but not required to take vitamin D supplements. The characteristics of the 3 treatment groups were similar at baseline except that preexisting vertebral fractures existed in 27.2% of the discontinuation group, in 30.8% of the 5 mg alendronate, and in 17.5% of the 10 mg alendronate groups. The women underwent annual measurement of bone mineral density at the lumbar spine to determine the primary endpoint of mean change from baseline in this measurement. After 10 years compared with baseline, women treated with 10 mg alendronate had a 13.7% increase in bone mineral density at the lumbar spine, while those treated with 5 mg and in the discontinuation group had a 9.3% increase. Similar comparisons of the femoral neck showed an increase of 5.4%, 2.8%, and 1.5%, of the trochanter showed an increase of 10.3%, 4.8%, and 5.3%, of the total hip showed 6.7%, 2.9%, and 3.4%, and of the total body showed an increase of 2.9%, 1.0%, and 1.8%, in the 10 mg, 5 mg, and discontinuation groups, respectively. Women in the discontinuation group sustained increases in bone mineral density over baseline levels overall, but measurements taken during the 5 years they received placebo revealed a gradual decline in bone mineral density measurements. One or more clinically adverse event during the 3 year extension occurred in 89.5%, 94.9%, and 92.8%, but these events resulted treatment stoppage in 4.7%, 6.4%, and 8.4% of the 10 mg, 5 mg, and discontinuation groups, respectively. "In summary, continuous treatment with 10 mg of alendronate daily for 10 years was associated with sustained therapeutic effects on bone density and remodeling," the authors conclude, adding "The discontinuation of alendronate resulted in a gradual diminution of effect."

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