Oral alendronate induces progressive increases in bone mass of the spine, hip, and total body over 3 years in postmenopausal women with osteoporosis
| Autor: | Ricardo Correa-Rotter, JM Kaufman, David C. Cumming, W. Yuan, M O R Leite, J P Devogelaer, Antonio Lombardi, C Nagant de Deuxchaisnes, Arthur C. Santora, P. J. Meunier, A. Vermeulen, K. Plezia, Ian R. Reid, Uri A. Liberman, A. J. Yates, P. Jaeger, J. Leon, Charles J. Menkes, Laurence J. Hirsch, Piet Geusens, H. Broll, A. Romanowicz, J. V. Rodríguez, David J. Hosking, Ego Seeman |
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| Rok vydání: | 1996 |
| Předmět: |
medicine.medical_specialty
Histology Bone disease Physiology Endocrinology Diabetes and Metabolism Osteoporosis Urology Administration Oral Placebo Bone remodeling Double-Blind Method Bone Density Internal medicine medicine Humans Osteoporosis Postmenopausal Aged Femoral neck Aged 80 and over Bone mineral Hip Lumbar Vertebrae Alendronate Trochanter business.industry Middle Aged medicine.disease Alendronate Sodium Endocrinology medicine.anatomical_structure Female business Biomarkers |
| Zdroj: | Bone. 18:141-150 |
| ISSN: | 8756-3282 |
| Popis: | To determine the effects of long-term daily oral alendronate sodium (ALN) on bone mass in postmenopausal women with osteoporosis, 19 centers enrolled 516 postmenopausal women aged 45-80 years with spine bone mineral density (BMD) at least 2.5 SD below the mean for young premenopausal women in a 3-year, double-blind, placebo-controlled study. Subjects were randomly allocated to one of four treatment groups: placebo; alendronate, 5 or 10 mg/day for 3 years; or alendronate, 20 mg/day for 2 years followed by 5 mg/day for the 3rd year. All patients received 500 mg/day of supplemental calcium to ensure adequate calcium intake. BMD was measured by dual-energy X-ray absorptiometry at several skeletal sites. Nonsignificant mean decreases in BMD of the spine, femoral neck, and trochanter of 0.6, 0.7, and 0.4%, respectively, occurred in the placebo group at 3 years. Relative to placebo-treated patients, spine BMD increased by 5.4%, 7.4%, and 8.4% in the 5, 10, and 20/5 mg ALN groups, respectively. Increases at the femoral neck were 3.5%, 5.5%, and 4.3%, and those at the trochanter were 5.1%, 7.2%, and 7.2%, respectively. Thus, efficacy of 10 and 20/5 mg ALN was similar, whereas the 5 mg dose was less effective. BMD continued to increase over the entire 3-year study duration in the ALN-treated groups and, compared with the other dosage groups, 10 mg ALN produced the largest gains in BMD during the 3rd year. Changes in biochemical markers of bone turnover and mineral homeostasis confirmed the effect of ALN to decrease bone turnover to a new steady-state level. The safety and tolerability of ALN were comparable with those of placebo. In summary, 10 mg daily oral ALN given for 3 years significantly and progressively increases bone mass and is a generally well-tolerated treatment for osteoporosis in postmenopausal women. |
| Databáze: | OpenAIRE |
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