title: Changes in bone mineral density are correlated with bone markers and reductions in hot flush severity in postmenopausal women treated with bazedoxifene/conjugated estrogens.
abstract: OBJECTIVE
  A post hoc exploratory analysis was conducted to examine correlations between changes in bone density, bone markers, and hot flushes after the treatment of postmenopausal women with bazedoxifene (BZA)/conjugated estrogens (CE).
  
  
  METHODS
  In a 2-year phase 3 study, 3,397 postmenopausal women were randomized to BZA 10 mg/CE 0.45 mg, BZA 20 mg/CE 0.45 mg, BZA 40 mg/CE 0.45 mg, BZA 10 mg/CE 0.625 mg, BZA 20 mg/CE 0.625 mg, BZA 40 mg/CE 0.625 mg, raloxifene 60 mg, or placebo. In this analysis, bone density changes at 2 years were compared with baseline levels of the bone markers serum C-telopeptide and osteocalcin. Correlations between changes in bone density and changes in 12-week hot flush composite scores in symptomatic women were also analyzed.
  
  
  RESULTS
  Treatment with BZA 20 mg/CE 0.45 mg or BZA 20 mg/CE 0.625 mg increased lumbar spine bone density more in women with higher bone resorption and formation, categorized by baseline levels of C-telopeptide and osteocalcin (P < 0.001, both BZA/CE doses). With placebo, larger decreases in lumbar spine bone density were seen in the highest tertile of serum C-telopeptide. There was no correlation between changes in total hip bone density and baseline bone markers. There were significant correlations between percent change in hot flush score at week 12 and percent changes in lumbar spine (r = -0.31, P = 0.006) and total hip (r = -0.23, P = 0.044) bone densities at month 24.
  
  
  CONCLUSIONS
  With 2-year BZA/CE treatment, women with larger increases in lumbar spine and total hip densities also have higher baseline bone markers. Early reductions in hot flush score (12 wk) are predictive of long-term increases in bone density (24 mo).
authors: From the 1Creighton University Medical Center, Omaha, NE; and 2Pfizer Inc, Collegeville, PA.
authors: John Christopher
authors: JC
authors: Gallagher
authors: Harry
authors: H
authors: Shi
authors: Sebastian
authors: S
authors: Mirkin
authors: Arkadi A
authors: AA
authors: Chines
mesh_terms: D015519:Bone Density / Q000187:drug effects*; D004305:Dose-Response Relationship, Drug; D004966:Estrogens, Conjugated (USP) / Q000008:administration & dosage*; D005260:Female; D019584:Hot Flashes / Q000188:drug therapy* / Q000517:prevention & control; D006801:Humans; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000517:prevention & control; D017698:Postmenopause / Q000187:drug effects*; D011788:Quality of Life; D020849:Raloxifene Hydrochloride / Q000008:administration & dosage*; D020845:Selective Estrogen Receptor Modulators / Q000008:administration & dosage*; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D004966:Estrogens, Conjugated (USP); D020845:Selective Estrogen Receptor Modulators; D020849:Raloxifene Hydrochloride