Article (Scientific journals)
Clinical evaluation of medicinal products for acceleration of fracture healing in patients with osteoporosis.
Goldhahn, Jörg; Scheele, Wim H.; Mitlak, Bruce H. et al.
2008In BONE, 43 (2), p. 343-7
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Keywords :
Clinical Trials as Topic; Drug Evaluation, Preclinical; Fracture Healing; Humans; Osteoporosis/drug therapy; Pharmaceutical Preparations; Treatment Outcome
Abstract :
[en] Pre-clinical studies indicate that pharmacologic agents can augment fracture union. If these pharmacologic approaches could be translated into clinical benefit and offered to patients with osteoporosis or patients with other risks for impaired fracture union (e.g. in subjects with large defects or open fractures with high complication rate), they could provide an important adjunct to the treatment of fractures. However, widely accepted guidelines are important to encourage the conduct of studies to evaluate bioactive substances, drugs, and new agents that may promote fracture union and subsequent return to normal function. A consensus process was initiated to provide recommendations for the clinical evaluation of potential therapies to augment fracture repair in patients with meta- and diaphyseal fractures. Based on the characteristics of fracture healing and fixation, the following study objectives of a clinical study may be appropriate: a) acceleration of fracture union, b) acceleration of return to normal function and c) reduction of fracture healing complications. The intended goal(s) should determine subsequent study methodology. While an acceleration of return to normal function or a reduction of fracture healing complications in and of themselves may be sufficient primary study endpoints for a phase 3 pivotal study, acceleration of fracture union alone is not. Radiographic evaluation may either occur at multiple time points during the healing process with the aim of measuring the time taken to reach a defined status (e.g. cortical bridging of three cortices or disappearance of fracture lines), or could be obtained at a single pre-determined timepoint, were patients are expected to reach a common clinical milestone (i.e. pain free full weight-bearing in weight-bearing fracture cases). Validated Patient Reported Outcomes (PRO's) measures will need to support the return to normal function co-primary endpoints. If reduction of complication rate (e.g. non-union) is the primary objective, the anticipated complications must be defined in the study protocol, along with their possible associations with the specified fracture type and fixation device. The study design should be randomized, parallel, double-blind, and placebo-controlled, and all fracture subjects should receive a standardized method of fracture fixation, defined as Standard of Care.
Disciplines :
General & internal medicine
Author, co-author :
Goldhahn, Jörg
Scheele, Wim H.;  Wyeth Research (Cambridge, MA)
Mitlak, Bruce H.
Abadie, Eric ;  AFSSAPS (France) > Département de l'Enregistrement et des Etudes Cliniques
Aspenberg, Per
Augat, Peter
Brandi, Maria-Luisa;  University of Florence > Department of Internal Medicine > Laboratory of Molecular Genetics > Metabolic Bone Unit
Burlet, Nansa
Chines, Arkadi
Delmas, Pierre D
Dupin-Roger, Isabelle
Ethgen, Dominique
Hanson, Beate
Hartl, Florian
Kanis, John A
Kewalramani, Reshma
Laslop, Andrea
Marsh, David
Ormarsdottir, Sif
Rizzoli, Rene
Santora, Art
Schmidmaier, Gerhard
Wagener, Michael
Reginster, Jean-Yves  ;  Université de Liège - ULiège > Département des sciences de la santé publique > Epidémiologie et santé publique
More authors (14 more) Less
Language :
English
Title :
Clinical evaluation of medicinal products for acceleration of fracture healing in patients with osteoporosis.
Publication date :
2008
Journal title :
BONE
ISSN :
8756-3282
eISSN :
1873-2763
Publisher :
Elsevier Science, New York, United States - New York
Volume :
43
Issue :
2
Pages :
343-7
Peer reviewed :
Peer Reviewed verified by ORBi
Available on ORBi :
since 28 August 2009

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