Clinical evaluation of medicinal products for acceleration of fracture healing in patients with osteoporosis

Bone

Volumn 43, Issue 2, 2008, Pages 343-347

  Goldhahn, Jörg ^a   Scheele, Wim H ^b   Mitlak, Bruce H ^c   Abadie, Eric ^d   Aspenberg, Per ^e   Augat, Peter ^f,g   Brandi, Maria Luisa ^h   Burlet, Nansa ⁱ   Chines, Arkadi ^b   Delmas, Pierre D ^j   Dupin Roger, Isabelle ^k   Ethgen, Dominique ^l   Hanson, Beate ^m   Hartl, Florian ⁿ   Kanis, John A ^o   Kewalramani, Reshma ^p   Laslop, Andrea ^q   Marsh, David ^r   Ormarsdottir, Sif ^s   Rizzoli, René ^t   Santora, Art ^u   Schmidmaier, Gerhard ^v   Wagener, Michael ^w   Reginster, Jean Yves ^x,y   more..

^a AO FOUNDATION   (Switzerland)

^b PFIZER INC   (United States)

^c ELI LILLY AND COMPANY   (United States)

^d AFSSAPS   (France)

^e LINKÖPING UNIVERSITY   (Sweden)

^f PARACELSUS MEDICAL UNIVERSITY   (Austria)

^g BG UNFALLKLINIK MURNAU   (Germany)

^h UNIVERSITY OF FLORENCE   (Italy)

ⁱ International Osteoporosis Foundation Switzerland   (Switzerland)

^j EDOUARD HERRIOT HOSPITAL   (France)

^k INSTITUT DE RECHERCHES INTERNATIONALES SERVIER   (France)

^l GLAXOSMITHKLINE   (United States)

^m AO Clinical Investigation and Documentation   (Switzerland)

ⁿ F HOFFMANN LA ROCHE LTD   (Switzerland)

^o UNIVERSITY OF SHEFFIELD   (United Kingdom)

^p AMGEN INC   (United States)

^q AUSTRIAN AGENCY FOR HEALTH AND FOOD SAFETY   (Austria)

^r QUEEN'S UNIVERSITY BELFAST   (United Kingdom)

^s Icelandic Medicines Control Agency   (Iceland)

^t WORLD HEALTH ORGANIZATION   (Switzerland)

^u MERCK RESEARCH LABORATORIES   (United States)

^v CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^w NOVARTIS PHARMA AG   (Switzerland)

^x UNIVERSITY OF LIÈGE   (Belgium)

^y GREES ^*

more..

Author keywords

Acceleration; Clinical trials; Fracture healing; Functional outcome; Guidelines; Medicinal product

Indexed keywords

DRUG CARRIER; PLACEBO; RECOMBINANT BONE MORPHOGENETIC PROTEIN 2; DRUG;

ALCOHOL ABUSE; ARTICLE; BIOMECHANICS; BONE RADIOGRAPHY; BONE REMODELING; BONE TURNOVER; CLINICAL EVALUATION; CLINICAL TRIAL; CONSENSUS; DIAPHYSIS; DRUG EFFECT; DRUG EFFICACY; DRUG SAFETY; FIXATION DEVICE; FRACTURE; FRACTURE FIXATION; FRACTURE HEALING; FRACTURE REDUCTION; HUMAN; METAPHYSIS; NARCOTIC DEPENDENCE; OSTEOPOROSIS; PSEUDARTHROSIS; TIBIA FRACTURE; WEIGHT BEARING; DRUG SCREENING; REVIEW; TREATMENT OUTCOME;

CLINICAL TRIALS AS TOPIC; DRUG EVALUATION, PRECLINICAL; FRACTURE HEALING; HUMANS; OSTEOPOROSIS; PHARMACEUTICAL PREPARATIONS; TREATMENT OUTCOME;

EID: 52449134212     PISSN: 87563282     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.bone.2008.04.017     Document Type: Article

References (23)

1. Marsh DR, Li G. The biology of fracture healing: optimising outcome. Br Med Bull 1999;55-4:856-69.
2. Gerstenfeld LC, Cullinane DM, Barnes GL, Graves DT, Einhorn TA. Fracture healing as a post-natal developmental process: molecular, spatial, and temporal aspects of its regulation. J Cell Biochem 2003;88-5:873-84.
3. J.A. Buckwalter, T.A. Einhorn, M.E. Bolander, R.L. Cruess, Healing of the musculoskeletal tissues. In: Rockwood C.A.j., Green D.P., Bucholz R.W., Heckman J.D., eds. Fractures in adults, 4 ed. Philadelphia, New York: Lippincott-Raven:261-304.
4. Lill CA, Hesseln J, Schlegel U, Eckhardt C, Goldhahn J, Schneider E. Biomechanical evaluation of healing in a non-critical defect in a large animal model of osteoporosis. J Orthop Res 2003;21-5:836-42.
5. Meyer Jr RA, Tsahakis PJ, Martin DF, Banks DM, Harrow ME, Kiebzak GM. Age and ovariectomy impair both the normalization of mechanical properties and the accretion of mineral by the fracture callus in rats. J Orthop Res 2001;19-3:428-35.
6. Kubo T, Shiga T, Hashimoto J, Yoshioka M, Honjo H, Urabe M, et al. Osteoporosis influences the late period of fracture healing in a rat model prepared by ovariectomy and low calcium diet. J Steroid Biochem Mol Biol 1999;68-5-6:197-202.
7. Goldhahn J, Suhm N, SG, Blauth M, Hanson B. Influence of osteoporosis on fracture fixation - a systematic literature review. Osteoporos Int 2007 Dec 8-[Electronic publication ahead of print].
8. Aspenberg P. Drugs and fracture repair. Acta Orthop 2005;76-6:741-8.
9. Einhorn TA. Enhancement of fracture-healing. J Bone Jt Surg Am 1995;77-6:940-56.
10. Goldhahn J, Mitlak B, Aspenberg P, Kanis JA, Rizzoli R, Reginster JY. GREES (Group for Respect of Ethics and Excellence in Science) Working Group on Bone Fracture-Healing. Critical issues in translational and clinical research for the study of new technologies to enhance bone repair. J Bone Jt Surg Am 2008 Feb;90 (Suppl 1):43-7.
11. Final Concept Paper M3(R2): Revision of ICH M3(R1): Maintenance of the ICH Guideline on Non-Clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals dated 9 September 2006. EU: Adopted by CPMP, September 97, issued as CPMP/ICH/286/95 - Amended Guideline: Adopted in November 2000, CPMP/ICH286/95 modification.
12. Egermann M, Goldhahn J, Schneider E. Animal models for fracture treatment in osteoporosis. Osteoporos Int 2005;16(Suppl 2):S129-38.
13. O'Loughlin PF, Morr S, Bogunovic L, Kim AD, Park B, Lane JM. Selection and development of preclinical models in fracture-healing research. J Bone Jt Surg Am Feb 2008;90(Suppl 1):79-84.
14. Augat P, Simon U, Liedert A, Claes L. Mechanics and mechano-biology of fracture healing in normal and osteoporotic bone. Osteoporos Int 2005;16(Suppl 2):S36-43.
15. Bhandari M, Guyatt GH, Swiontkowski MF, Tornetta III P, Sprague S, Schemitsch EH. A lack of consensus in the assessment of fracture healing among orthopaedic surgeons. J Orthop Trauma 2002;16-8:562-6.
16. Madanat R, Moritz N, Larsson S, Aro HT. RSA applications in monitoring of fracture healing in clinical trials. Scand J Surg 2006;95-2:119-27.
17. Pynsent P, Fairbank J, Carr A. Outcome measures in orthopaedics and orthopaedic trauma. 2nd Edition. Arnold; 2004.
18. CHMP. Reflection paper on the regulatory guidance for the use of health related quality of life (HRQL) measures in the evaluation of medicinal products. London: European Medicines Agency (EMEA):1-5.
19. Guidance for Industry for Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims Center for Drug Evaluation and Research, Food and Drug Administration. http://www.fda.gov/cder/ guidance/index.htm.
20. Angst F, Goldhahn J, Drerup S, Aeschlimann A, Schwyzer HK, Simmen BR. Responsiveness of six outcome assessment instruments in total shoulder arthroplasty. Arthritis Rheum 2008 Mar 15;59(3):391-8.
21. Govender S, Csimma C, Genant HK, et al. Recombinant human bone morphogenetic Protein-2 for treatment of open tibial fractures: a prospective, controlled, randomized study of four hundred and fifty patients. J Bone Jt Surg Am 2002;84:2123-34.
22. http://www.emea.europa.eu/htms/human/humanguidelines/efficacy.htm.
23. Csimma C, Swiontkowski MF. Large clinical trials in musculoskeletal trauma: are they possible? Lessons learned from the international study of the use of rhBMP-2 in open tibial fractures. J Bone Jt Surg Am 2005;87-1:218-22.