Osteoporosis International

, Volume 13, Issue 6, pp 443–449

Uncertain Future of Trials in Osteoporosis

  • J. A. Kanis
  • A. Oden
  • O. Johnell
  • F. Caulin
  • H. Bone
  • J.-M. Alexandre
  • E. Abadie
  • F.  Lekkerkerker
Review Article

DOI: 10.1007/s001980200052

Cite this article as:
Kanis, J., Oden, A., Johnell, O. et al. Osteoporos Int (2002) 13: 443. doi:10.1007/s001980200052

Abstract:

The advent of effective agents for the treatment of osteoporosis has led to the view that placebo-controlled trials to test new agents for efficacy are no longer appropriate since proven treatments are available. In this review we argue that, if new agents are to be developed, there is still a place for the placebo-controlled trial. A move to studies of equivalence or non-inferiority raises more problems than it resolves.

Key words:Comparator studies – Drug treatment – Fracture – Medical ethics – Placebo-controlled trials

Copyright information

© International Osteoporosis Foundation and National Osteoporosis Foundation 2002

Authors and Affiliations

  • J. A. Kanis
    • 1
  • A. Oden
    • 2
  • O. Johnell
    • 3
  • F. Caulin
    • 4
  • H. Bone
    • 5
  • J.-M. Alexandre
    • 6
  • E. Abadie
    • 7
  • F.  Lekkerkerker
    • 8
  1. 1.WHO Collaborating Centre for Metabolic Bone Diseases, University of Sheffield Medical School, Sheffield, UKUK
  2. 2.Solberg, Romelanda, SwedenSweden
  3. 3.Department of Orthopaedics, Malmo¨ General Hospital, SwedenSweden
  4. 4.FC Consulting SA, Paris, FranceFrance
  5. 5.Michigan Bone & Mineral Clinic, Detroit, Michigan, USAUSA
  6. 6.Ho^pital Europe´en George Pompidou, Paris, FranceFrance
  7. 7.AFFSAPS, 143 bd Anatole France, St Denis, France;France
  8. 8.Medicines Evaluation Board, The NetherlandsThe Netherlands