Skeletal benefits of alendronate: 7-year treatment of postmenopausal osteoporotic women. Phase III Osteoporosis Treatment Study Group

We report here the second 2-yr extension of a clinical trial among postmenopausal women; 235 women continued blinded treatment with 5 or 10 mg alendronate daily, and 115 women who had been treated with alendronate for 5 yr were switched to blinded placebo. Continuous treatment with alendronate (10 m...

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Bibliographic Details
Published in:The journal of clinical endocrinology and metabolism 2000-09, Vol.85 (9), p.3109
Main Authors: Tonino, R P, Meunier, P J, Emkey, R, Rodriguez-Portales, J A, Menkes, C J, Wasnich, R D, Bone, H G, Santora, A C, Wu, M, Desai, R, Ross, P D
Format: Article
Language:English
Subjects:
Absorptiometry, Photon
Aged
Alendronate - adverse effects
Alendronate - therapeutic use
Bone and Bones - diagnostic imaging
Bone Density - drug effects
Double-Blind Method
Female
Humans
Middle Aged
Osteoporosis, Postmenopausal - drug therapy
Osteoporosis, Postmenopausal - pathology
Time Factors
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Summary:We report here the second 2-yr extension of a clinical trial among postmenopausal women; 235 women continued blinded treatment with 5 or 10 mg alendronate daily, and 115 women who had been treated with alendronate for 5 yr were switched to blinded placebo. Continuous treatment with alendronate (10 mg daily) for 7 yr increased lumbar spine bone mineral density (BMD) by 11.4% compared to baseline. After the initial 18 months, each additional year of treatment through yr 7 increased spine BMD by 0.8% for the 10-mg dose and 0.6% for the 5-mg dose, with significant increases during yr 6-7. Previously reported increases in BMD at other skeletal sites and decreases in biochemical markers of bone turnover remained stable during yr 6-7. Among women previously taking alendronate for 5 yr who were switched to placebo, there was no significant decline in BMD at the spine or hip, whereas small, but significant, decreases in BMD at the forearm and total body and small increases in biochemical markers were observed. The safety and tolerability profiles were similar to those of placebo. This is the largest published long-term study of antiresorptive therapy. Our findings indicate that long-term alendronate treatment is well tolerated and effective for 7 yr. Increases in spinal BMD continue for at least 7 yr, and other skeletal benefits are maintained. Discontinuation does not lead to accelerated bone loss, but continuous treatment yields better skeletal benefits than shorter treatment.
ISSN:0021-972X