Osteoporosis International

, Volume 22, Issue 6, pp 1725–1735

Adherence, preference, and satisfaction of postmenopausal women taking denosumab or alendronate

  • D. L. Kendler
  • M. R. McClung
  • N. Freemantle
  • M. Lillestol
  • A. H. Moffett
  • J. Borenstein
  • S. Satram-Hoang
  • Y.-C. Yang
  • P. Kaur
  • D. Macarios
  • S. Siddhanti
  • on behalf of the DAPS Investigators
Original Article

DOI: 10.1007/s00198-010-1378-z

Cite this article as:
Kendler, D.L., McClung, M.R., Freemantle, N. et al. Osteoporos Int (2011) 22: 1725. doi:10.1007/s00198-010-1378-z
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Abstract

Summary

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.

Introduction

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.

Keywords

AdherenceAlendronateComplianceDenosumabPersistence

Copyright information

© International Osteoporosis Foundation and National Osteoporosis Foundation 2010

Authors and Affiliations

  • D. L. Kendler
    • 1
  • M. R. McClung
    • 2
  • N. Freemantle
    • 3
  • M. Lillestol
    • 4
  • A. H. Moffett
    • 5
  • J. Borenstein
    • 6
  • S. Satram-Hoang
    • 7
  • Y.-C. Yang
    • 7
  • P. Kaur
    • 7
  • D. Macarios
    • 7
  • S. Siddhanti
    • 7
  • on behalf of the DAPS Investigators
  1. 1.University of British ColumbiaVancouverCanada
  2. 2.Oregon Osteoporosis CenterPortlandUSA
  3. 3.University of BirminghamBirminghamUK
  4. 4.Internal Medicine AssociatesFargoUSA
  5. 5.OB-GYN Associates of Mid FloridaLeesburgUSA
  6. 6.Cedars-Sinai Health SystemBeverly HillsUSA
  7. 7.Amgen Inc.Thousand OaksUSA