Yonsei Med J.  2009 Aug;50(4):474-481. 10.3349/ymj.2009.50.4.474.

Comparison of the Effects of Alendronate and Alfacalcidol on Hip Bone Mineral Density and Bone Turnover in Japanese Men Having Osteoporosis or Osteopenia with Clinical Risk Factors for Fractures

• Iwamoto J
• Sato Y
• Uzawa M
• Takeda T
• Matsumoto

• KMID: 1758605
• DOI: http://doi.org/10.3349/ymj.2009.50.4.474

Abstract

PURPOSE
The comparative effects of alendronate and alfacalcidol on bone mineral density (BMD) and bone turnover have already been established in postmenopausal women with osteoporosis. An open-labeled prospective study was conducted to compare the treatment effects of alendronate and alfacalcidol on hip BMD and bone turnover in Japanese men with osteoporosis or osteopenia with clinical risk factors for fractures. MATERIALS AND METHODS: One hundred twelve men with osteoporosis or osteopenia with clinical risk factors for fractures (mean age: 71.4 years) were randomly divided into two groups of 56 patients each: the alendronate (5 mg daily) and alfacalcidol (1 microgram daily) groups. The BMD of the total hip, urinary level of cross-linked N-terminal telopeptides of type I collagen (NTX), and serum levels of bone-specific alkaline phosphatase (BSAP) were measured during the 12-month-treatment period. RESULTS: Forty-five patients in the alendronate group and 42 patients in the alfacalcidol group completed the trial. Alendronate increased BMD (+2.3% at 12 months) following reductions in the urinary level of NTX (-46.4% at 3 months) and serum level of BSAP (-34.1% at 12 months), while alfacalcidol sustained BMD (-1.9% at 12 months) as well as the urinary level of NTX (+13.2% at 3 months) and serum level of BSAP (+1.8% at 12 months). CONCLUSION: The present study confirmed that alendronate has better efficacy than alfacalcidol (active control) in increasing hip BMD and reducing bone turnover in Japanese men with osteoporosis or osteopenia with clinical risk factors for fractures.

Keyword

Alendronate; alfacalcidol; fracture risk; men; osteoporosis; osteopenia

MeSH Terms

Aged
Aged, 80 and over
Alendronate/pharmacology/therapeutic use
Asian Continental Ancestry Group
Bone Density/*drug effects
*Bone Density Conservation Agents/pharmacology/therapeutic use
Bone Diseases, Metabolic/*drug therapy
Fractures, Bone/*prevention & control
Hip Joint/*drug effects/pathology
Humans
*Hydroxycholecalciferols/pharmacology/therapeutic use
Male
Middle Aged
Osteoporosis/*drug therapy
Treatment Outcome

Figure

• 

  Fig. 1 Percent changes in serum calcium, phosphorus, BSAP and PTH. Data are expressed as the mean ± SE. The serum level of BSAP significantly decreased, but the serum levels of calcium, phosphorus, and intact PTH did not significantly change in the alendronate group (one-way ANOVA with repeated measurements, Table 2). The serum level of calcium significantly increased, but the serum levels of phosphorus, BSAP, and intact PTH did not significantly change in the alfacalcidol group (one-way ANOVA with repeated measurements, Table 2). There were significant differences in changes in the serum levels of calcium and BSAP between the two groups (two-way ANOVA with repeated measurements, Table 2). n = 45 in the alendronate group and n = 42 in the alfacalcidol group. BSAP, bone-specific alkaline phosphatase; PTH, parathyroid hormone.

• 

  Fig. 2 Percent changes in total hip BMD. Data are expressed as the mean ± SE. The BMD significantly increased, but did not significantly change in the alfacalcidol group (one-way ANOVA with repeated measurements, Table 2). There was a significant difference in changes in the BMD between the two groups (two-way ANOVA with repeated measurements, Table 2). n = 45 in the alendronate group and n = 2 in the alfacalcidol group. BMD, bone mineral density.

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