title: A randomized, double-blind, placebo-controlled study to evaluate the effects of alendronate on bone mineral density and bone remodelling in perimenopausal women with low bone mineral density.
abstract: BACKGROUND
  Perimenopausal women can experience rapid bone loss at skeletal sites with both cortical and cancellous bone, increasing the prevalence of osteoporosis following menopause.
  
  
  METHODS
  We conducted a 12-month randomized placebo-controlled trial evaluating the effects of alendronate 70 mg with 2800 IU cholecalciferol administered once per week for 12 months in comparison with placebo and cholecalciferol. The primary end-point was the percentage change in the lumbar spine bone mineral density (BMD) from baseline to 12 months. Secondary end-points were the change in BMD at the femoral neck and changes in biochemical markers of bone turnover.
  
  
  RESULTS
  Forty-five women were recruited to participate in the study. Five subjects withdrew from the study before randomization for unrelated reasons. Forty subjects were randomly allocated to the alendronate and placebo groups. The mean lumbar spine MD in women treated with alendronate increased by 3.66% (mean paired difference, μd = 0.032; ± 0.008 SE) at 12 months, compared with a reduction of 3.33% (μd = -0.030; ± 0.008 SE) in the control group (P < 0.001). In the femoral neck, the mean BMD in the alendronate group increased by 2.07% (μd = 0.014; ± 0.009 SE) at 12 months, compared with a reduction of 1.87% (μd = -0.014; ± 0.008 SE) in the control group (P = 0.046). There were no differences in BMD between the alendronate and placebo groups at the total hip sites after 12 months. At 12 months, both bone-specific alkaline phosphatase and urinary N-telopeptide were significantly reduced, by 37.79% (μd = -9.90; ± 1.92 SE) and 27.21% (μd = -11.68; ± 4.80 SE) respectively, in the alendronate group; in the control group, these levels increased (P < 0.001).
  
  
  CONCLUSIONS
  Weekly treatment with alendronate 70 mg and cholecalciferol 2800 IU increases BMD and decreases bone turnover in perimenopausal women.
authors.affiliation: Department of Medicine, McMaster University, Hamilton ON; Bone Research and Education Centre, Oakville ON.
authors.forename: Aliya
authors.initials: A
authors.lastname: Khan
authors.affiliation: Department of Health and Behavioural Sciences, Lakehead University, Thunder Bay ON; Human Sciences Division, Northern Ontario School of Medicine, Thunder Bay ON; Research Department, St. Joseph's Care Group, Thunder Bay ON.
authors.forename: Sacha
authors.initials: S
authors.lastname: Dubois
authors.affiliation: Bone Research and Education Centre, Oakville ON.
authors.forename: Amina A
authors.initials: AA
authors.lastname: Khan
authors.affiliation: Bone Research and Education Centre, Oakville ON.
authors.forename: M
authors.initials: M
authors.lastname: Zohair Rahman
authors.affiliation: Bone Research and Education Centre, Oakville ON.
authors.forename: O
authors.initials: O
authors.lastname: Ahmed Khan
authors.affiliation: Bone Research and Education Centre, Oakville ON.
authors.forename: Hamid T
authors.initials: HT
authors.lastname: Syed
authors.affiliation: Departments of Obstetrics and Gynaecology and Internal Medicine (Endocrinology), University of Toronto, Toronto ON.
authors.forename: Christine
authors.initials: C
authors.lastname: Derzko
mesh_terms: D000328:Adult; D019386:Alendronate / Q000627:therapeutic use*; D050071:Bone Density Conservation Agents / Q000627:therapeutic use*; D016723:Bone Remodeling / Q000187:drug effects*; D002762:Cholecalciferol / Q000627:therapeutic use; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008875:Middle Aged; D010024:Osteoporosis / Q000188:drug therapy*; D047648:Perimenopause
chemical_list: D050071:Bone Density Conservation Agents; D002762:Cholecalciferol; D019386:Alendronate
keywords: alendronate; bisphosphonate; fracture risk; osteoporosis; perimenopause