title: Additive impact of alfacalcidol on bone mineral density and bone strength in alendronate treated postmenopausal women with reduced bone mass.
abstract: OBJECTIVE
  Assessment of additive impact of alfacalcidol 1 μg daily (Alfa) on bone mineral density (BMD) and on bone strength in postmenopausal women treated with alendronate 70 mg weekly + 500 mg calcium daily.
  
  
  METHODS
  In a randomized, double-blind, placebo controlled study, 279 postmenopausal women with osteoporosis or osteopenia participated (intention to treat analysis [ITT]; aged 73.6∓4.7 years) and were treated with 70 mg alendronate (ALN) weekly and 500 mg calcium daily for 36 months. In addition, these patients received either 1 μg alfacalcidol (Alfa) or placebo (PLC) daily. BMD was measured with Dual-Energy-X-ray-Absorptiometry (DXA) at the lumbar spine and proximal femur and at forearm and tibia with peripheral quantitative computed tomography (pQCT) at regular intervals for 36 months.
  
  
  RESULTS
  DXA-BMD of lumbar spine (L1-4) increased after 36 months, by 6.65% (p<0.0001) in the Alfa/ALN group versus 4.17% (p<0.0001) in the PLC/ALN group. Group difference was significant after 3 years (p=0.026). At the end of the study, significant differences were found in favor of the Alfa/ALN group in trabecular density (tibia) (p=0.002), cortical density (midshaft tibia) (p=0.043), and bone strength (p=0.001). The remaining parameters showed no differences between the treatment arms, apart cortical bone density at midshaft radius.
  
  
  CONCLUSIONS
  Alfacalcidol significantly increases the efficacy of alendronate treatment in osteopenic/osteoporotic postmenopausal women on spinal DXA-BMD, cortical and trabecular BMD of the tibia and also bending stiffness of the tibia.
authors.affiliation: Center of Muscle and Bone Research, Charité - University Medicine Berlin, Campus Benjamin Franklin, Free University and Humboldt University Berlin, Berlin, Germany. dieter.felsenberg@charite.de
authors.forename: D
authors.initials: D
authors.lastname: Felsenberg
authors.forename: O
authors.initials: O
authors.lastname: Bock
authors.forename: H
authors.initials: H
authors.lastname: Börst
authors.forename: G
authors.initials: G
authors.lastname: Armbrecht
authors.forename: G
authors.initials: G
authors.lastname: Beller
authors.forename: C
authors.initials: C
authors.lastname: Degner
authors.forename: M
authors.initials: M
authors.lastname: Stephan-Oelkers
authors.forename: E
authors.initials: E
authors.lastname: Schacht
authors.forename: Z
authors.initials: Z
authors.lastname: Mazor
authors.forename: J
authors.initials: J
authors.lastname: Hashimoto
authors.forename: H-J
authors.initials: HJ
authors.lastname: Roth
authors.forename: P
authors.initials: P
authors.lastname: Martus
authors.forename: M
authors.initials: M
authors.lastname: Runge
mesh_terms: D000368:Aged; D019386:Alendronate / Q000008:administration & dosage* / Q000009:adverse effects; D015519:Bone Density / Q000187:drug effects* / Q000502:physiology; D050071:Bone Density Conservation Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001862:Bone Resorption / Q000188:drug therapy* / Q000503:physiopathology; D001842:Bone and Bones / Q000187:drug effects*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D006887:Hydroxycholecalciferols / Q000008:administration & dosage* / Q000009:adverse effects; D015663:Osteoporosis, Postmenopausal / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000503:physiopathology; D011859:Radiography
chemical_list: D050071:Bone Density Conservation Agents; D006887:Hydroxycholecalciferols; C008088:alfacalcidol; D019386:Alendronate