title: Effects of risedronate or alfacalcidol on bone mineral density, bone turnover, back pain, and fractures in Japanese men with primary osteoporosis: results of a two-year strict observational study.
abstract: Although osteoporosis in men is already a major public health problem, there is still a dearth of data about the effects of risedronate in male osteoporosis, especially in Japanese with primary osteoporosis. Therefore, the objective of our study was to investigate the effects of risedronate on bone mineral density (BMD), bone turnover, back pain, and fractures in these patients prospectively for two years (at baseline, three months, six months, twelve months, and twenty-four months) both longitudinally and compared with those of alfacalcidol. The subjects enrolled for this study were 66 Japanese male patients with untreated primary osteoporosis (mean age 63.52 +/- 8.7 years), who were divided into two groups (44 with risedronate and 22 with alfacalcidol). We measured BMD by dual energy X-ray absorptiometry at three sites-the lumbar spine, femoral neck, and distal radius. Risedronate treatment significantly increased BMD at the lumbar spine and at the femoral neck, reduced bone-specific alkaline phosphatase (BAP) and serum N-terminal telopeptide of type I collagen (NTx), and reduced back pain, both longitudinally and compared with alfacalcidol treatment. We observed a lower rate of incident fracture in risedronate users. However, multiple logistic regression analysis revealed that this trend was not statistically significant, possibly because of the small number of patients enrolled. These potentially beneficial effects of risedronate on bone in male patients with primary osteoporosis suggest the possibility that osteoporosis should be treated with risedronate regardless of gender in order to effectively prevent subsequent osteoporotic fractures.
authors.affiliation: Division of Endocrinology and Metabolism, Clinical Research Institute for Endocrine Metabolic Diseases, National Hospital Organization, Kyoto Medical Center, 1-1 Mukaihata-cho, Fushimi-ku, Kyoto 612-8555, Japan. spdf3ea9@room.ocn.ne.jp
authors.forename: Takafumi
authors.initials: T
authors.lastname: Majima
authors.forename: Akira
authors.initials: A
authors.lastname: Shimatsu
authors.forename: Yasato
authors.initials: Y
authors.lastname: Komatsu
authors.forename: Noriko
authors.initials: N
authors.lastname: Satoh
authors.forename: Atsushi
authors.initials: A
authors.lastname: Fukao
authors.forename: Kiyoshi
authors.initials: K
authors.lastname: Ninomiya
authors.forename: Tadashi
authors.initials: T
authors.lastname: Matsumura
authors.forename: Kazuwa
authors.initials: K
authors.lastname: Nakao
mesh_terms: D000368:Aged; D044466:Asian People; D001416:Back Pain / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D001827:Body Height / Q000187:drug effects; D015519:Bone Density / Q000187:drug effects; D050071:Bone Density Conservation Agents / Q000494:pharmacology / Q000627:therapeutic use; D016723:Bone Remodeling / Q000187:drug effects; D002118:Calcium / Q000378:metabolism; D012968:Etidronic Acid / Q000031:analogs & derivatives* / Q000494:pharmacology / Q000627:therapeutic use; D050723:Fractures, Bone / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D006801:Humans; D006887:Hydroxycholecalciferols / Q000494:pharmacology / Q000627:therapeutic use*; D007564:Japan; D008297:Male; D008875:Middle Aged; D010024:Osteoporosis / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D010710:Phosphates / Q000378:metabolism; D000068296:Risedronic Acid
chemical_list: D050071:Bone Density Conservation Agents; D006887:Hydroxycholecalciferols; D010710:Phosphates; D000068296:Risedronic Acid; D012968:Etidronic Acid; D002118:Calcium; C008088:alfacalcidol