title: Denosumab and alendronate treatment in patients with back pain due to fresh osteoporotic vertebral fractures.
abstract: BACKGROUND
  Denosumab specifically inhibits the receptor activator for nuclear factor-kappa B ligand (RANKL), and prevents osteoporotic fractures. Several reports have analyzed the effects of denosumab and alendronate alone on bone mineral density (BMD) or reduction of fracture risk. The objective of this study was to analyze the effects of antiresorptive osteoporosis pharmacotherapy on pain relief in patients with fresh vertebral fracture.
  
  
  METHODS
  This retrospective, single-center study included 80 patients (10 males, 70 females) with fresh osteoporotic vertebral fractures treated using denosumab at a dose of 60 mg subcutaneously every 6 months (40 patients) or alendronate at a dose of 35 mg orally every week (40 patients) for 6 months in our hospital. The mean age of subjects was 77 years (range, 55-92 years). The primary outcome was duration of back pain. Secondary outcomes included changes in BMD, serum type 1 collagen cross-linked N-telopeptide (NTX), and serum N-terminal propeptide of type 1 collagen (P1NP) from baseline to 6 months. Pain catastrophizing due to back pain was assessed using the Pain Catastrophizing Scale (PCS). The incidences of further vertebral fracture and adverse events were also assessed.
  
  
  RESULTS
  Pain relief was obtained at a mean of 3.3 weeks with denosumab and 5.4 weeks with alendronate. Pain relief was achieved significantly earlier with denosumab than with alendronate. At 6 months, change in BMD was higher with denosumab (6.1%) than with alendronate (0.8%). No significant differences in changes in NTX and P1NP were observed between groups. Scores for PCS were significantly lower for denosumab than for alendronate. The incidence of further vertebral fractures was 5% with denosumab and 10% with alendronate. Adverse event rates were similar between groups.
  
  
  CONCLUSIONS
  Denosumab enabled earlier pain relief than alendronate and avoided catastrophizing in patients with osteoporotic vertebral fractures after 6 months of treatment.
authors.affiliation: Department of Orthopaedic Surgery, Okayama University, 2-5-1 Shikata-cho, Kitaku, Okayama 700-8558, Japan; Department of Orthopaedic Surgery, Kurashiki Municipal Hospital, 2-39, Kojima-Ekimae, Kurashiki 711-0921, Japan.
authors.forename: Tomoko
authors.initials: T
authors.lastname: Tetsunaga
authors.affiliation: Department of Orthopaedic Surgery, Okayama University, 2-5-1 Shikata-cho, Kitaku, Okayama 700-8558, Japan. Electronic address: tomonori_t31@yahoo.co.jp.
authors.forename: Tomonori
authors.initials: T
authors.lastname: Tetsunaga
authors.affiliation: Department of Human Morphology, Okayama University, 2-5-1 Shikata-cho, Kitaku, Okayama 700-8558, Japan.
authors.forename: Keiichiro
authors.initials: K
authors.lastname: Nishida
authors.affiliation: Department of Orthopaedic Surgery, Okayama University, 2-5-1 Shikata-cho, Kitaku, Okayama 700-8558, Japan.
authors.forename: Masato
authors.initials: M
authors.lastname: Tanaka
authors.affiliation: Department of Orthopaedic Surgery, Okayama University, 2-5-1 Shikata-cho, Kitaku, Okayama 700-8558, Japan.
authors.forename: Yoshihisa
authors.initials: Y
authors.lastname: Sugimoto
authors.affiliation: Department of Orthopaedic Surgery, Okayama University, 2-5-1 Shikata-cho, Kitaku, Okayama 700-8558, Japan.
authors.forename: Tomoyuki
authors.initials: T
authors.lastname: Takigawa
authors.affiliation: Department of Orthopaedic Surgery, Kurashiki Municipal Hospital, 2-39, Kojima-Ekimae, Kurashiki 711-0921, Japan.
authors.forename: Yoshitaka
authors.initials: Y
authors.lastname: Takei
authors.affiliation: Department of Orthopaedic Surgery, Okayama University, 2-5-1 Shikata-cho, Kitaku, Okayama 700-8558, Japan.
authors.forename: Toshifumi
authors.initials: T
authors.lastname: Ozaki
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D019386:Alendronate / Q000627:therapeutic use*; D015331:Cohort Studies; D000069448:Denosumab / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D017102:Fracture Healing / Q000187:drug effects; D006801:Humans; D017116:Low Back Pain / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000209:etiology; D008297:Male; D008875:Middle Aged; D058866:Osteoporotic Fractures / Q000150:complications / Q000000981:diagnostic imaging / Q000188:drug therapy*; D010147:Pain Measurement; D012189:Retrospective Studies; D018570:Risk Assessment; D016103:Spinal Fractures / Q000000981:diagnostic imaging / Q000188:drug therapy*; D014057:Tomography, X-Ray Computed / Q000379:methods; D016896:Treatment Outcome
chemical_list: D000069448:Denosumab; D019386:Alendronate