Abstract:
OBJECTIVE:To evaluate the efficacy and tolerability of alendronic acid 70mg once weekly for the treatment of male osteoporosis. PATIENTS AND METHODS:This randomised, double-blind, placebo-controlled, 12-month trial compared the effect of alendronic acid 70mg once weekly or placebo (randomised 2 : 1) on bone mineral density (BMD) in 167 men with spine or hip BMD at least 2 standard deviations (SD) below the mean for young normal white males or nontraumatic fracture. All patients received calcium and vitamin D (colecalciferol). We measured lumbar spine, hip and total body BMD, and biochemical markers of bone turnover. Fractures were collected as adverse events. RESULTS:Alendronic acid 70mg once weekly produced significant BMD increases from baseline of 4.3% at the spine, 2.1% at the femoral neck, 2.4% at the trochanter, and 1.4% at the total body, which were all significantly greater than placebo (p < 0.05). The increase at the lumbar spine was significant relative to baseline and placebo after 6 months of treatment (p < 0.001). The treatment effect was consistent regardless of BMD, age, height, weight, body mass index (BMI) and hypogonadal status at baseline. Alendronic acid significantly decreased biochemical markers of bone turnover relative to baseline and placebo. Alendronic acid was generally well tolerated, with an incidence of gastrointestinal adverse events similar to placebo. CONCLUSION:Alendronic acid 70mg administered once weekly is an effective and convenient alternative to daily dosing for the treatment of male osteoporosis.
journal_name
Clin Drug Investigjournal_title
Clinical drug investigationauthors
Miller PD,Schnitzer T,Emkey R,Orwoll E,Rosen C,Ettinger M,Vandormael K,Daifotis Adoi
10.2165/00044011-200424060-00003subject
Has Abstractpub_date
2004-01-01 00:00:00pages
333-41issue
6eissn
1173-2563issn
1179-1918pii
2463journal_volume
24pub_type
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journal_title:Clinical drug investigation
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pub_type: 临床试验,杂志文章,meta分析,多中心研究
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abstract::Page 806, column 1, line 3: The text, which previously read. ...
journal_title:Clinical drug investigation
pub_type: 已发布勘误
doi:10.1007/s40261-020-00892-9
更新日期:2020-03-01 00:00:00