title: Daily or Cyclical Teriparatide Treatment in Women With Osteoporosis on no Prior Therapy and Women on Alendronate.
abstract: BACKGROUND
  Intermittent 3-month cyclic administration might optimize the anabolic potential of teriparatide (TPTD).
  
  
  OBJECTIVE
  To determine whether 3-month cyclical TPTD would produce a similar bone mineral density (BMD) response to daily therapy in treatment naive (Rx-naive) women and to confirm the results in alendronate (ALN)-treated (ALN-Rx) women over 24 months.
  
  
  METHODS
  Subjects participated in a randomized open-label study for 2 years.
  
  
  METHODS
  Osteoporosis clinical research center.
  
  
  METHODS
  A total of 150 postmenopausal women with osteoporosis in two cohorts: 86 Rx-naive and 64 ALN-Rx.
  
  
  METHODS
  Within cohorts, women were randomized to daily TPTD for 24 months or four 3-month TPTD cycles, each followed by 3 months off (12 mo total TPTD).
  
  
  RESULTS
  BMD at 24 months.
  
  
  RESULTS
  In Rx-naive women, BMD increased in the lumbar spine (LS), total hip (TH), trochanter (Troch), and femoral neck (FN) in daily and cyclic groups (within groups, P < .0002, except cyclic FN, P = .13). Increases were 2-fold greater in daily vs cyclic groups (LS, 8.8 vs 4.8%; TH, 4.0 vs 2.1%; Troch, 5.6 vs 3.1%; and FN, 2.9 vs 1.2%; group differences, all P < .05). In daily vs cyclic groups, radius BMD declined (-4.2 vs -2.1%, respectively; both P < .01; group difference, P = .08) and total bone mineral increased modestly (1.4%, P = .18; vs 1.5%, P = .06; group difference, not significant). In ALN-Rx women, there were no group differences (daily vs cyclic: LS, 7.5 and 6.0%; TH, 3 and 2.5%; Troch, 3.7 and 3.3%; FN, 3 and 1.5%; within groups, P < .003; except cyclic FN, P = .2). In daily and cyclic groups, radius BMD decreased (-0.7% [not significant] and -1.4% [P < .05], respectively), and total bone mineral increased 2.3 and 3% (both P < .001).
  
  
  CONCLUSIONS
  Cyclic TPTD over 2 years improves BMD similarly to daily treatment in women who remain on ALN, despite only 50% of the TPTD dose. However, there does not appear to be a BMD advantage to cyclic administration in treatment-naive women for up to 24 months.
authors.affiliation: Regional Bone Center and Clinical Research Centers (F.C., J.W.N., M.Z., P.G., S.N., D.D., R.L.), Helen Hayes Hospital, West Haverstraw, New York 10993; and Departments of Medicine (F.C., R.L.), Epidemiology (J.W.N.), and Pathology and Cell Biology (D.D.), Columbia University, New York, New York 10032.
authors.forename: Felicia
authors.initials: F
authors.lastname: Cosman
authors.affiliation: Regional Bone Center and Clinical Research Centers (F.C., J.W.N., M.Z., P.G., S.N., D.D., R.L.), Helen Hayes Hospital, West Haverstraw, New York 10993; and Departments of Medicine (F.C., R.L.), Epidemiology (J.W.N.), and Pathology and Cell Biology (D.D.), Columbia University, New York, New York 10032.
authors.forename: Jeri W
authors.initials: JW
authors.lastname: Nieves
authors.affiliation: Regional Bone Center and Clinical Research Centers (F.C., J.W.N., M.Z., P.G., S.N., D.D., R.L.), Helen Hayes Hospital, West Haverstraw, New York 10993; and Departments of Medicine (F.C., R.L.), Epidemiology (J.W.N.), and Pathology and Cell Biology (D.D.), Columbia University, New York, New York 10032.
authors.forename: Marsha
authors.initials: M
authors.lastname: Zion
authors.affiliation: Regional Bone Center and Clinical Research Centers (F.C., J.W.N., M.Z., P.G., S.N., D.D., R.L.), Helen Hayes Hospital, West Haverstraw, New York 10993; and Departments of Medicine (F.C., R.L.), Epidemiology (J.W.N.), and Pathology and Cell Biology (D.D.), Columbia University, New York, New York 10032.
authors.forename: Patricia
authors.initials: P
authors.lastname: Garrett
authors.affiliation: Regional Bone Center and Clinical Research Centers (F.C., J.W.N., M.Z., P.G., S.N., D.D., R.L.), Helen Hayes Hospital, West Haverstraw, New York 10993; and Departments of Medicine (F.C., R.L.), Epidemiology (J.W.N.), and Pathology and Cell Biology (D.D.), Columbia University, New York, New York 10032.
authors.forename: Simon
authors.initials: S
authors.lastname: Neubort
authors.affiliation: Regional Bone Center and Clinical Research Centers (F.C., J.W.N., M.Z., P.G., S.N., D.D., R.L.), Helen Hayes Hospital, West Haverstraw, New York 10993; and Departments of Medicine (F.C., R.L.), Epidemiology (J.W.N.), and Pathology and Cell Biology (D.D.), Columbia University, New York, New York 10032.
authors.forename: David
authors.initials: D
authors.lastname: Dempster
authors.affiliation: Regional Bone Center and Clinical Research Centers (F.C., J.W.N., M.Z., P.G., S.N., D.D., R.L.), Helen Hayes Hospital, West Haverstraw, New York 10993; and Departments of Medicine (F.C., R.L.), Epidemiology (J.W.N.), and Pathology and Cell Biology (D.D.), Columbia University, New York, New York 10032.
authors.forename: Robert
authors.initials: R
authors.lastname: Lindsay
mesh_terms: D000368:Aged; D019386:Alendronate / Q000627:therapeutic use*; D015415:Biomarkers / Q000097:blood; D015519:Bone Density / Q000187:drug effects; D050071:Bone Density Conservation Agents / Q000008:administration & dosage* / Q000009:adverse effects; D016723:Bone Remodeling / Q000187:drug effects; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000097:blood / Q000188:drug therapy* / Q000453:epidemiology; D058866:Osteoporotic Fractures / Q000453:epidemiology; D019379:Teriparatide / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D015415:Biomarkers; D050071:Bone Density Conservation Agents; D019379:Teriparatide; D019386:Alendronate