title: Effect of raloxifene after recombinant teriparatide [hPTH(1-34)] treatment in postmenopausal women with osteoporosis.
abstract: Loss of bone mineral density occurs after discontinuation of teriparatide, if no subsequent treatment is given. Sequential raloxifene prevented rapid bone loss at lumbar spine and further increased bone mineral density (BMD) at femoral neck, whether raloxifene was started immediately or after a one-year delay following teriparatide treatment.
  
  
  BACKGROUND
  We compared the sequential effects of raloxifene treatment with a placebo on teriparatide-induced increases in bone mineral density (BMD). A year of open-label raloxifene extended the study to assess the response with and without delay after discontinuation of teriparatide.
  
  
  METHODS
  Following a year of open-label teriparatide 20 mug/day treatment, postmenopausal women with osteoporosis were randomly assigned to raloxifene 60 mg/day (n = 157) or a placebo (n = 172) for year 2, followed by a year of open-label raloxifene. BMD was measured by dual energy x-ray absorptiometry.
  
  
  RESULTS
  The raloxifene and placebo groups showed a decrease in lumbar spine (LS) BMD in year 2 for raloxifene and placebo groups (-1.0 +/- 0.3%, P = 0.004; and -4.0 +/- 0.3%, P < 0.001, respectively); the decrease was less with raloxifene (P < 0.001). Open-label raloxifene treatment reversed the LS BMD decrease with a placebo, resulting in similar decreases 2 years after randomization (-2.6 +/- 0.4% (raloxifene-raloxifene) and -2.7 +/- 0.4% (placebo-placebo). At study end, LS and femoral neck (FN) BMD were higher than pre-teriparatide levels, with no significant differences between the raloxifene-raloxifene and placebo-raloxifene groups, respectively (LS: 6.1 +/- 0.5% vs. 5.1 +/- 0.5%; FN: 3.4 +/- 0.6% vs. 3.0 +/- 0.5%).
  
  
  CONCLUSIONS
  Sequential raloxifene prevented rapid bone loss at the LS and increased FN BMD whether raloxifene was started immediately or after a one-year delay following teriparatide treatment.
authors.affiliation: Riabilitazione Reumatologica, University of Verona, Valeggio s/Mincio, Verona, Italy. silvano.adami@univr.it
authors.forename: S
authors.initials: S
authors.lastname: Adami
authors.forename: J
authors.initials: J
authors.lastname: San Martin
authors.forename: M
authors.initials: M
authors.lastname: Muñoz-Torres
authors.forename: M J
authors.initials: MJ
authors.lastname: Econs
authors.forename: L
authors.initials: L
authors.lastname: Xie
authors.forename: G P
authors.initials: GP
authors.lastname: Dalsky
authors.forename: M
authors.initials: M
authors.lastname: McClung
authors.forename: D
authors.initials: D
authors.lastname: Felsenberg
authors.forename: J P
authors.initials: JP
authors.lastname: Brown
authors.forename: M L
authors.initials: ML
authors.lastname: Brandi
authors.forename: A
authors.initials: A
authors.lastname: Sipos
mesh_terms: D000368:Aged; D001315:Australia; D015519:Bone Density / Q000187:drug effects*; D050071:Bone Density Conservation Agents / Q000008:administration & dosage*; D002170:Canada; D005060:Europe; D005260:Female; D005272:Femur Neck / Q000737:chemistry / Q000187:drug effects; D006801:Humans; D008159:Lumbar Vertebrae / Q000737:chemistry / Q000187:drug effects; D015663:Osteoporosis, Postmenopausal / Q000188:drug therapy*; D020849:Raloxifene Hydrochloride / Q000008:administration & dosage*; D019379:Teriparatide / Q000008:administration & dosage*; D014481:United States
chemical_list: D050071:Bone Density Conservation Agents; D019379:Teriparatide; D020849:Raloxifene Hydrochloride