Critical Issues in Translational and Clinical Research for the Study of New Technologies to Enhance Bone Repair
; Jörg Goldhahn, MD; Bruce Mitlak, MD; Per Aspenberg, MD, PhD; John A. Kanis, MD; René Rizzoli, MD; Jean-Yves Reginster, MD, PhD

Abstract

Osteoporosis increases fracture risk, especially in metaphyseal bone. Fractures seriously impair function and quality of life and incur large direct and indirect costs. Although the prevention of fractures is certainly the option, a fast and uneventful healing process is optimal when fractures do occur. Many new therapeutic strategies have been developed to accelerate fracture-healing or to diminish the complication rate during the course of fracture-healing. However, widely accepted guidelines are needed to demonstrate the positive or negative interactions of bioactive substances, drugs, and other agents that are being used to promote fracture-healing. For each study design, the primary study goal should be indicated. Outcome variables should include both objective and subjective parameters. The guidelines should be harmonized between European and American regulatory authorities to ensure comparability of results of studies and to foster global harmonization of regulatory requirements.

Footnotes

  • Disclosure: The authors did not receive any outside funding or grants in support of their research for or preparation of this work. One or more of the authors, or a member of his or her immediate family, received, in any one year, payments or other benefits of less than $10,000 or a commitment or agreement to provide such benefits from a commercial entity (Eli Lilly and Company). No commercial entity paid or directed, or agreed to pay or direct, any benefits to any research fund, foundation, division, center, clinical practice, or other charitable or nonprofit organization with which the authors,or a member of their immediate families, are affiliated or associated.

  • Note: The GREES (Group for the Respect of Ethics and Excellence in Science) working group on bone fracture-healing consists of the following individuals: Eric Abadie, Per Aspenberg, Peter Augat, Maria-Luisa Brandi, Nansa Burlet, Arkadi Chines, Pierre Delmas, Will Dere, Isabelle Dupin-Roger, Dominique Ethgen, Jörg Goldhahn, John A. Kanis, Joel Krasnow, Gottfried Kreutz, Andrea Laslop, Frits Lekkerkerker, David Marsh, Bruce Mitlak, Sif Ormarsdottir, Jean-Yves Reginster, René Rizzoli, Art Santora, Gerhard Schmidmaier, and Michael Wagener.


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