title: A prospective analytical study of the effects and adverse events of alendronate (Aldren70) treatment in Thai postmenopausal women.
abstract: OBJECTIVE
  To elucidate the efficacy and adverse events of alendronate (Aldren70) after 12 months of treatment in 50 to 70 years old postmenopausal women.
  
  
  METHODS
  The authors observed 50 postmenopausal women who had clinical conditions of osteopenia or osteoporosis and had never been treated with alendronate acid. Bone mineral density (BMD) of L1-L4, the left hip, and the left forearm were performed at the initial assessment and after 12 months of treatment. The serum levels of osteocalcin (OC), procollagen type 1 N-terminal propeptide (PINP) and beta-crosslaps (beta-CTx) were performed at the baseline and then after 3 months, 6 months and 12 months of treatment. The data were analyzed using the SPSS software. Paired t-test was used to compare lumbar spine, hip and forearm before and after treatment.
  
  
  RESULTS
  Treated by using Aldren70 once weekly for one year the BMD of the lumbar spine increased highly up to 11.26% (g/cm2) and 25.82% (T-score) from the base line (p < 0.001 and p < 0.001, respectively). On the other hand, the change in BMD of the left hip increased 17.54% (g/cm2), 8.2% (T-score), at the left forearm increased 3.96% (g/cm2), 7.62% (T-score) after 12 months respectively. There was significant increase of BMD between before and after 12 months. The mean values of bone markers at the 0.05 level before treatment, three months, six months, and 12 months of treatment in osteocalcin were 0.2813, 0.1242, 0.896, and 0.0889 ng/ml respectively. The PINP were 36.1762, 19.3894, 14.3084, and 15.1260 ng/ml respectively. Beta-crosslaps were 0.2813, 0.1242, 0.0896, and 0.0889 ng/ml respectively. Adverse events found in five patients were the symptoms of stomachache (2.4%), constipation/diarrhea (1.2%), palpitation (1.2%), and muscle/bone pain (1.2%).
  
  
  CONCLUSIONS
  The generic alendronate (Aldren 70) in our clinical trial was found to be highly effective at the spine concerning the bone mass improvement and less at the hip and wrist joints in comparison. All the result figures met the standard efficacy after 12 months follow-up by increasing bone mass and reducing serum bone markers.
authors.forename: Prakit
authors.initials: P
authors.lastname: Tienboon
authors.forename: Nara
authors.initials: N
authors.lastname: Jaruwangsanti
mesh_terms: D000368:Aged; D019386:Alendronate / Q000009:adverse effects / Q000627:therapeutic use*; D015415:Biomarkers / Q000097:blood; D015519:Bone Density / Q000187:drug effects; D050071:Bone Density Conservation Agents / Q000627:therapeutic use*; D001851:Bone Diseases, Metabolic / Q000097:blood / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000097:blood / Q000188:drug therapy*; D011446:Prospective Studies
chemical_list: D015415:Biomarkers; D050071:Bone Density Conservation Agents; D019386:Alendronate