title: The Direct Assessment of Nonvertebral Fractures in Community Experience (DANCE) study: 2-year nonvertebral fragility fracture results.
abstract: This observational study evaluated the occurrence of nonvertebral fragility fractures (NVFX) in over 4,000 men and women with osteoporosis treated with teriparatide (TPTD). The incidence of new NVFX decreased for patients receiving TPTD treatment for greater than 6 months. No new significant safety findings were observed in this large trial.
  
  
  BACKGROUND
  The Direct Assessment of Nonvertebral Fractures in Community Experience (DANCE) study evaluated the occurrence of NVFX in patients receiving TPTD for osteoporosis in a real-world setting.
  
  
  METHODS
  DANCE is a multicenter, prospective, observational trial that examined the long-term effectiveness of TPTD in men and women with osteoporosis whom study physicians judged to be suitable for TPTD therapy. Patients received 20 μg TPTD per day by subcutaneous injection for up to 24 months and were followed for 24 months after treatment cessation. The incidence of patients experiencing a new NVFX, defined as a fracture associated with low trauma, was evaluated during four 6-month periods in both the treatment and cessation phases with >0 to ≤6 months serving as the reference. We also observed the spectrum and occurrence of serious adverse events.
  
  
  RESULTS
  Of the 4,167 patients enrolled, 4,085 took one or more doses of TPTD (safety population); 3,720 were included in the efficacy analysis. The incidence of patients experiencing a NVFX was 1.42, 0.91, 0.70, and 0.81 % for the four treatment periods, respectively, and 0.80, 0.68, 0.33, and 0.33 % for the four periods after treatment cessation. Differences for each period were statistically significant compared with the reference period (first 6-month interval, each p < 0.05). No new significant safety findings were observed.
  
  
  CONCLUSIONS
  In this study, the incidence of NVFX decreased for patients receiving TPTD for all three treatment periods >6 months compared to 0 to ≤6 months, and this trend persisted throughout the cessation phase. TPTD was generally well tolerated.
authors: Cedars-Sinai/UCLA Medical Center and OMC Clinical Research Center, 8641 Wilshire Blvd, Suite 301, Beverly Hills, CA 90211, USA. stuarts@omcresearch.org
authors: S
authors: S
authors: Silverman
authors: P
authors: P
authors: Miller
authors: A
authors: A
authors: Sebba
authors: M
authors: M
authors: Weitz
authors: X
authors: X
authors: Wan
authors: J
authors: J
authors: Alam
authors: D
authors: D
authors: Masica
authors: K A
authors: KA
authors: Taylor
authors: V A
authors: VA
authors: Ruff
authors: K
authors: K
authors: Krohn
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D015519:Bone Density / Q000187:drug effects; D050071:Bone Density Conservation Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D005260:Female; D005272:Femur Neck / Q000503:physiopathology; D006621:Hip Joint / Q000503:physiopathology; D006801:Humans; D008159:Lumbar Vertebrae / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D010024:Osteoporosis / Q000188:drug therapy* / Q000453:epidemiology / Q000503:physiopathology; D015663:Osteoporosis, Postmenopausal / Q000188:drug therapy / Q000453:epidemiology / Q000503:physiopathology; D058866:Osteoporotic Fractures / Q000453:epidemiology / Q000503:physiopathology / Q000517:prevention & control*; D011446:Prospective Studies; D019379:Teriparatide / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D014481:United States
chemical_list: D050071:Bone Density Conservation Agents; D019379:Teriparatide
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