title: Adherence, preference, and satisfaction of postmenopausal women taking denosumab or alendronate.
abstract: In this study, 250 women with osteoporosis were randomized to 12 months with subcutaneous denosumab 60 mg every 6 months or oral alendronate 70 mg once weekly, then crossed over to the other treatment. The primary endpoint, treatment adherence at 12 months, was 76.6% for alendronate and 87.3% for denosumab.
  
  
  BACKGROUND
  The purpose of this study is to evaluate treatment adherence with subcutaneous denosumab 60 mg every 6 months or oral alendronate 70 mg once weekly.
  
  
  METHODS
  In this multicenter, randomized, open-label, 2-year, crossover study, 250 postmenopausal women with low bone mineral density received denosumab or alendronate for 12 months, then the other treatment for 12 months. The alendronate bottle had a medication event monitoring system cap to monitor administration dates. Definitions were as follows: compliance, receiving both denosumab doses 6 (± 1) months apart or 80-100% of alendronate doses; persistence, receiving both denosumab doses and completing the month 12 visit within the visit window or ≥ 2 alendronate doses in the final month; adherence, achieving both compliance and persistence. This report includes data from the first 12 months.
  
  
  RESULTS
  The primary study endpoint, adherence in the first 12 months, was 76.6% (95/124) for alendronate and 87.3% (110/126) for denosumab. Risk ratios for denosumab compared with alendronate at 12 months were 0.58 (p = 0.043) for non-adherence, 0.48 (p = 0.014) for non-compliance, and 0.54 (p = 0.049) for non-persistence. Subject ratings for treatment necessity, preference, and satisfaction were significantly greater for denosumab and ratings for treatment bother were significantly greater for alendronate. Adverse events were reported by 64.1% of alendronate-treated subjects and 72.0% of denosumab-treated subjects (p = 0.403). The most common adverse events were arthralgia, back pain, pain in extremity, cough, and headache (each in <10% of subjects in each group).
  
  
  CONCLUSIONS
  Significantly greater treatment adherence was observed for subcutaneous administration of denosumab every 6 months than for oral alendronate once weekly.
authors.affiliation: University of British Columbia, 600-1285 West Broadway, V6H 3X8 Vancouver, BC, Canada. kendler@ca.inter.net
authors.forename: D L
authors.initials: DL
authors.lastname: Kendler
authors.forename: M R
authors.initials: MR
authors.lastname: McClung
authors.forename: N
authors.initials: N
authors.lastname: Freemantle
authors.forename: M
authors.initials: M
authors.lastname: Lillestol
authors.forename: A H
authors.initials: AH
authors.lastname: Moffett
authors.forename: J
authors.initials: J
authors.lastname: Borenstein
authors.forename: S
authors.initials: S
authors.lastname: Satram-Hoang
authors.forename: Y-C
authors.initials: YC
authors.lastname: Yang
authors.forename: P
authors.initials: P
authors.lastname: Kaur
authors.forename: D
authors.initials: D
authors.lastname: Macarios
authors.forename: S
authors.initials: S
authors.lastname: Siddhanti
mesh_terms: D000284:Administration, Oral; D000368:Aged; D019386:Alendronate / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D015519:Bone Density / Q000187:drug effects; D050071:Bone Density Conservation Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001955:British Columbia; D000069448:Denosumab; D004812:Epidemiologic Methods; D005260:Female; D006801:Humans; D007279:Injections, Subcutaneous; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology; D057240:Patient Preference / Q000706:statistics & numerical data; D017060:Patient Satisfaction / Q000706:statistics & numerical data; D016896:Treatment Outcome; D016903:Drug Monitoring
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D050071:Bone Density Conservation Agents; D000069448:Denosumab; D019386:Alendronate
references.citation: J Bone Miner Res. 2004 Jul;19(7):1059-66
references.pmid: 15176987
references.citation: N Engl J Med. 2006 Feb 23;354(8):821-31
references.pmid: 16495394
references.citation: Mayo Clin Proc. 2006 Aug;81(8):1013-22
references.pmid: 16901023
references.citation: Osteoporos Int. 2010 Nov;21(11):1943-51
references.pmid: 19967338
references.citation: Osteoporos Int. 2005 May;16(5):447-55
references.pmid: 15609073
references.citation: Calcif Tissue Int. 2010 Mar;86(3):202-210
references.pmid: 20063188
references.citation: Osteoporos Int. 2005 Mar;16 Suppl 2:S3-7
references.pmid: 15365697
references.citation: Aging Clin Exp Res. 2005 Apr;17(2):143-9
references.pmid: 15977463
references.citation: Curr Med Res Opin. 2006 Dec;22(12):2383-91
references.pmid: 17257452
references.citation: Osteoporos Int. 2009 Nov;20(11):1895-902
references.pmid: 19296144
references.citation: Bone. 2008 Aug;43(2):222-9
references.pmid: 18539106
references.citation: J Clin Endocrinol Metab. 2000 Sep;85(9):3109-15
references.pmid: 10999794
references.citation: Int J STD AIDS. 2004 Jan;15(1):38-44
references.pmid: 14769170
references.citation: Bone. 2007 Jul;41(1):122-8
references.pmid: 17468062
references.citation: Med Care. 2005 Dec;43(12):1203-7
references.pmid: 16299431
references.citation: Mayo Clin Proc. 2007 Dec;82(12):1493-501
references.pmid: 18053457
references.citation: Cochrane Database Syst Rev. 2008 Jan 23;(1):CD004523
references.pmid: 18254053
references.citation: J Bone Miner Res. 2009 Jan;24(1):153-61
references.pmid: 18767928
references.citation: JAMA. 2004 Jul 28;292(4):490-5
references.pmid: 15280347
references.citation: Clin Ther. 2002 Nov;24(11):1871-86
references.pmid: 12501880
references.citation: JAMA. 1997 Jan 1;277(1):63-4
references.pmid: 8980212
references.citation: Cochrane Database Syst Rev. 2008 Jan 23;(1):CD001155
references.pmid: 18253985
references.citation: Cochrane Database Syst Rev. 2008 Jan 23;(1):CD003376
references.pmid: 18254018
references.citation: Bone. 2009 Jan;44(1):153-9
references.pmid: 18926939
references.citation: Osteoporos Int. 2010 May;21(5):837-46
references.pmid: 19657689
references.citation: Maturitas. 2004 Jul 15;48(3):243-51
references.pmid: 15207890
references.citation: Curr Med Res Opin. 2005 Dec;21(12):1895-903
references.pmid: 16368038
references.citation: J Clin Endocrinol Metab. 2007 Apr;92(4):1296-304
references.pmid: 17244788
references.citation: Bone. 2006 Jun;38(6):922-8
references.pmid: 16330270
references.citation: Clin Rheumatol. 2009 Mar;28(3):321-6
references.pmid: 19031095
references.citation: J Psychosom Res. 1999 Dec;47(6):555-67
references.pmid: 10661603
references.citation: Osteoporos Int. 2004 Nov;15(11):897-902
references.pmid: 15490120
references.citation: Joint Bone Spine. 2008 May;75(3):303-10
references.pmid: 18069036
references.citation: Curr Opin Pharmacol. 2005 Dec;5(6):618-25
references.pmid: 16188502
references.citation: Osteoporos Int. 2004 Dec;15(12):1003-8
references.pmid: 15167989
references.citation: J Bone Miner Res. 2007 Dec;22(12):1832-41
references.pmid: 17708711
references.citation: Bone. 2009 Dec;45(6):1084-90
references.pmid: 19664735