title: Critical issues in translational and clinical research for the study of new technologies to enhance bone repair.
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.
authors.affiliation: Department of Research, Schulthess Klinik, Lengghalde 2, Zurich 8008, Switzerland. joerg.goldhahn@kws.ch
authors.forename: Jörg
authors.initials: J
authors.lastname: Goldhahn
authors.forename: Bruce
authors.initials: B
authors.lastname: Mitlak
authors.forename: Per
authors.initials: P
authors.lastname: Aspenberg
authors.forename: John A
authors.initials: JA
authors.lastname: Kanis
authors.forename: René
authors.initials: R
authors.lastname: Rizzoli
authors.forename: Jean-Yves
authors.initials: JY
authors.lastname: Reginster
mesh_terms: D000328:Adult; D005060:Europe; D005260:Female; D017102:Fracture Healing / Q000187:drug effects / Q000502:physiology*; D050723:Fractures, Bone / Q000209:etiology / Q000503:physiopathology / Q000628:therapy; D006801:Humans; D008297:Male; D010024:Osteoporosis / Q000150:complications; D017410:Practice Guidelines as Topic; D011788:Quality of Life; D014481:United States