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Critical Issues in Translational and Clinical Research for the Study of New Technologies to Enhance Bone Repair

Goldhahn, Jörg, MD; Mitlak, Bruce, MD; Aspenberg, Per, MD, PhD; Kanis, John A., MD; Rizzoli, René, MD; Reginster, Jean-Yves, MD, PhD; the GREES (Group for the Respect of Ethics and Excellence in Science) Working Group on Bone Fracture-Healing

doi: 10.2106/JBJS.G.01090
Symposium Articles
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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.

Corresponding author: Jörg Goldhahn, MD Department of Research, Schulthess Klinik, Lengghalde 2, Zurich 8008, Switzerland. E-mail address: joerg.goldhahn@kws.ch

Copyright © 2008 by The Journal of Bone and Joint Surgery, Incorporated
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