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.
OBJECTIVE
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.


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 microg 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).


CONCLUSIONS
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.
Iwamoto
Jun
J
Institute for Integrated Sports Medicine, Keio University School of Medicine, Tokyo, Japan. jiwamoto@sc.itc.keio.ac.jp
Sato
Yoshihiro
Y
Uzawa
Mitsuyoshi
M
Takeda
Tsuyoshi
T
Matsumoto
Hideo
H
D000368:Aged; D000369:Aged, 80 and over; D019386:Alendronate / Q000494:pharmacology / Q000627:therapeutic use; D044466:Asian People; D015519:Bone Density / Q000187:drug effects*; D050071:Bone Density Conservation Agents / Q000494:pharmacology / Q000627:therapeutic use; D001851:Bone Diseases, Metabolic / Q000188:drug therapy*; D050723:Fractures, Bone / Q000517:prevention & control*; D006621:Hip Joint / Q000187:drug effects* / Q000473:pathology; D006801:Humans; D006887:Hydroxycholecalciferols / Q000494:pharmacology / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D010024:Osteoporosis / Q000188:drug therapy*; D016896:Treatment Outcome
D050071:Bone Density Conservation Agents; D006887:Hydroxycholecalciferols; C008088:alfacalcidol; D019386:Alendronate