Adult; Europe; Female; Fracture Healing/drug effects/physiology; Fractures, Bone/etiology/physiopathology/therapy; Humans; Male; Osteoporosis/complications; Practice Guidelines as Topic; Quality of Life; United States
Abstract :
[en] 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.
Disciplines :
General & internal medicine
Author, co-author :
Goldhahn, Jorg
Mitlak, Bruce
Aspenberg, Per
Kanis, John A
Rizzoli, Rene
Reginster, Jean-Yves ; Université de Liège - ULiège > Département des sciences de la santé publique > Epidémiologie et santé publique
Language :
English
Title :
Critical issues in translational and clinical research for the study of new technologies to enhance bone repair.
Publication date :
2008
Journal title :
Journal of Bone and Joint Surgery. American Volume
ISSN :
0021-9355
eISSN :
1535-1386
Publisher :
Journal of Bone and Joint Surgery, Boston, United States - Massachusetts
Butcher, J.L., MacKenzie, E.J., Cushing, B., Jurkovich, G., Morris, J., Burgess, A., McAndrew, M., Swiontkowski, M., Long-term outcomes after lower extremity trauma (1996) J Trauma, 41, pp. 4-9
MacKenzie, E.J., Bosse, M.J., Pollak, A.N., Webb, L.X., Swiontkowski, M.F., Kellam, J.F., Smith, D.G., Castillo, R.C., Long-term persistence of disability following severe lower-limb trauma. Results of a seven-year follow-up (2005) J Bone Joint Surg Am, 87, pp. 1801-1809
Yi, L., Jingping, B., Gele, J., Baoleri, X., Taixiang, W., Operative versus non-operative treatment for thoracolumbar burst fractures without neurological deficit (2006) Cochrane Database Syst Rev, 4. , CD005079
Parker, M.J., Gurusamy, K., Internal fixation versus arthroplasty for intracapsular proximal femoral fractures in adults (2006) Cochrane Database Syst Rev, 4. , CD001708
Bhandari, M., Devereaux, P.J., McKee, M.D., Schemitsch, E.H., Compression plating versus intramedullary nailing of humeral shaft fractures - a meta-analysis (2006) Acta Orthop, 77, pp. 279-284
Handoll, H.H., Gibson, J.N., Madhok, R., Interventions for treating proximal humeral fractures in adults (2003) Cochrane Database Syst Rev, 4. , CD000434
Handoll, H.H., Madhok, R., Surgical interventions for treating distal radial fractures in adults (2003) Cochrane Database Syst Rev, 3. , CD003209
Reginster, J.Y., Burlet, N., Osteoporosis: A still increasing prevalence (2006) Bone, 38 (2 SUPPL. 1), pp. S4-S9
Johnell, O., Kanis, J.A., An estimate of the worldwide prevalence and disability associated with osteoporotic fractures (2006) Osteoporos Int, 17, pp. 1726-1733
Chrischilles, E., Shireman, T., Wallace, R., Costs and health effects of osteoporotic fractures (1994) Bone, 15, pp. 377-386
Rabenda, V., Manette, C., Lemmens, R., Mariani, A.M., Struvay, N., Reginster, J.Y., The direct and indirect costs of the chronic management of osteoporosis: A prospective follow-up of 3440 active subjects (2006) Osteoporos Int, 17, pp. 1346-1352
Burge, R., Dawson-Hughes, B., Solomon, D.H., Wong, J.B., King, A., Tosteson, A., Incidence and economic burden of osteoporosis-related fractures in the United States, 2005-2025 (2007) J Bone Miner Res, 22, pp. 465-475
Lübbeke, A., Stern, R., Grab, B., Herrmann, F., Michel, J.P., Hoffmeyer, P., Upper extremity fractures in the elderly: Consequences on utilization of rehabilitation care (2005) Aging Clin Exp Res, 17, pp. 276-280
Gabriel SE, Tosteson AN, Leibson CL, Crowson CS, Pond GR, Hammond CS, Melton LJ 3rd. Direct medical costs attributable to osteoporotic fractures. Osteoporos Int. 2002
13:323-30
Lippuner, K., Golder, M., Greiner, R., Epidemiology and direct medical costs of osteoporotic fractures in men and women in Switzerland (2005) Osteoporos Int, 16 (SUPPL. 2), pp. S8-S17
Schmidmaier, G., Lucke, M., Schwabe, P., Raschke, M., Haas, N.P., Wildemann, B., Collective review: Bioactive implants coated with poly(D,L-lactide) and growth factors IGF-I, TGF-beta1, or BMP-2 for stimulation of fracture healing (2006) J Long Term Eff Med Implants, 16, pp. 61-69
Kain, M.S., Einhorn, T.A., Recombinant human bone morphogenetic proteins in the treatment of fractures (2005) Foot Ankle Clin, 10, pp. 639-650. , viii
Aspenberg, P., Drugs and fracture repair (2005) Acta Orthop, 76, pp. 741-748
Gerstenfeld, L.C., Cullinane, D.M., Barnes, G.L., Graves, D.T., Einhorn, T.A., Fracture healing as a post-natal developmental process: Molecular, spatial, and temporal aspects of its regulation (2003) J Cell Biochem, 88, pp. 873-884
Skripitz, R., Aspenberg, P., Parathyroid hormone - a drug for orthopedic surgery? (2004) Acta Orthop Scand, 75, pp. 654-662
Kawaguchi, H., Kurokawa, T., Hanada, K., Hiyama, Y., Tamura, M., Ogata, E., Matsumoto, T., Stimulation of fracture repair by recombinant human basic fibroblast growth factor in normal and streptozotocin-diabetic rats (1994) Endocrinology, 135, pp. 774-781
Chen, W.J., Jingushi, S., Aoyama, I., Anzai, J., Hirata, G., Tamura, M., Iwamoto, Y., Effects of FGF-2 on metaphyseal fracture repair in rabbit tibiae (2004) J Bone Miner Metab, 22, pp. 303-309
Schmidmaier, G., Wildemann, B., Ostapowicz, D., Kandziora, F., Stange, R., Haas, N.P., Raschke, M., Long-term effects of local growth factor (IGF-I and TGF-beta 1) treatment on fracture healing. A safety study for using growth factors (2004) J Orthop Res, 22, pp. 514-519
Raschke, M., Kolbeck, S., Bail, H., Schmidmaier, G., Flyvbjerg, A., Lindner, T., Dahne, M., Haas, N., Homologous growth hormone accelerates healing of segmental bone defects (2001) Bone, 29, pp. 368-373
Andreassen, T.T., Oxlund, H., Local anabolic effects of growth hormone on intact bone and healing fractures in rats (2003) Calcif Tissue Int, 73, pp. 258-264
Laursen, M., Hoy, K., Hansen, E.S., Gelineck, J., Christensen, F.B., Bunger, C.E., Recombinant bone morphogenetic protein-7 as an intracorporal bone growth stimulator in unstable thoracolumbar burst fractures in humans: Preliminary results (1999) Eur Spine J, 8, pp. 485-490
Kaneko, H., Arakawa, T., Mano, H., Kaneda, T., Ogasawara, A., Nakagawa, M., Toyama, Y., Hakeda, Y., Direct stimulation of osteoclastic bone resorption by bone morphogenetic protein (BMP)-2 and expression of BMP receptors in mature osteoclasts (2000) Bone, 27, pp. 479-486
Jeppsson, C., Astrand, J., Tagil, M., Aspenberg, P., A combination of bisphosphonate and BMP additives in impacted bone allografts (2003) Acta Orthop Scand, 74, pp. 483-489
Aspenberg, P., Basic, N., Tägil, M., Vukicevic, S., Reduced expression of BMP-3 due to mechanical loading: A link between mechanical stimuli and tissue differentiation (2000) Acta Orthop Scand, 71, pp. 558-562
Bostrom, M.P., Aspenberg, P., Jeppsson, C., Salvati, E.A., Enhancement of bone formation in the setting of repeated tissue deformation (1998) Clin Orthop Relat Res, 350, pp. 221-228
Andreassen, T.T., Ejersted, C., Oxlund, H., Intermittent parathyroid hormone (1-34) treatment increases callus formation and mechanical strength of healing rat fractures (1999) J Bone Miner Res, 14, pp. 960-968
Andreassen, T.T., Fledelius, C., Ejersted, C., Oxlund, H., Increases in callus formation and mechanical strength of healing fractures in old rats treated with parathyroid hormone (2001) Acta Orthop Scand, 72, pp. 304-307
Seebach, C., Skripitz, R., Andreassen, T.T., Aspenberg, P., Intermittent parathyroid hormone (1-34) enhances mechanical strength and density of new bone after distraction osteogenesis in rats (2004) J Orthop Res, 22, pp. 472-478
Tanaka, M., Sakai, A., Uchida, S., Tanaka, S., Nagashima, M., Katayama, T., Yamaguchi, K., Nakamura, T., Prostaglandin E2 receptor (EP4) selective agonist (ONO-4819.CD) accelerates bone repair of femoral cortex after drill-hole injury associated with local upregulation of bone turnover in mature rats (2004) Bone, 34, pp. 940-948
Paralkar, V.M., Borovecki, F., Ke, H.Z., Cameron, K.O., Lefker, B., Grasser, W.A., Owen, T.A., Thompson, D.D., An EP2 receptor-selective prostaglandin E2 agonist induces bone healing (2003) Proc Natl Acad Sci U S A, 100, pp. 6736-6740
Mundy, G., Garrett, R., Harris, S., Chan, J., Chen, D., Rossini, G., Boyce, B., Gutierrez, G., Stimulation of bone formation in vitro and in rodents by statins (1999) Science, 286, pp. 1946-1949
Skoglund, B., Forslund, C., Aspenberg, P., Simvastatin improves fracture healing in mice (2002) J Bone Miner Res, 17, pp. 2004-2008
Takeda, S., Elefteriou, F., Levasseur, R., Liu, X., Zhao, L., Parker, K.L., Armstrong, D., Karsenty, G., Leptin regulates bone formation via the sympathetic nervous system (2002) Cell, 111, pp. 305-317
Minkowitz, B., Boskey, A.L., Lane, J.M., Pearlman, H.S., Vigorita, V.J., Effects of propranolol on bone metabolism in the rat (1991) J Orthop Res, 9, pp. 869-875
Amanat, N., McDonald, M., Godfrey, C., Bilston, L., Little, D., Optimal timing of a single dose of zoledronic acid to increase strength in rat fracture repair (2007) J Bone Miner Res, 22, pp. 867-876
Seebeck, J., Goldhahn, J., Städele, H., Messmer, P., Morlock, M.M., Schneider, E., Effect of cortical thickness and cancellous bone density on the holding strength of internal fixator screws (2004) J Orthop Res, 22, pp. 1237-1242
Goldhahn, J., Reinhold, M., Stauber, M., Knop, C., Frei, R., Schneider, E., Linke, B., Improved anchorage in osteoporotic vertebrae with new implant designs (2006) J Orthop Res, 24, pp. 917-925
Dayer, R., Rizzoli, R., Kaelin, A., Ammann, P., Low protein intake is associated with impaired titanium implant osseointegration (2006) J Bone Miner Res, 21, pp. 258-264
Skripitz, R., Aspenberg, P., Attachment of PMMA cement to bone: Force measurements in rats (1999) Biomaterials, 20, pp. 351-356
Skripitz, R., Aspenberg, P., Early effect of parathyroid hormone (1-34) on implant fixation (2001) Clin Orthop Relat Res, 392, pp. 427-432
Skripitz, R., Bohling, S., Rüther, W., Aspenberg, P., Stimulation of implant fixation by parathyroid hormone (1-34). A histomorphometric comparison of PMMA cement and stainless steel (2005) J Orthop Res, 23, pp. 1266-1270
Moroni, A., Faldini, C., Hoang-Kim, A., Pegreffi, F., Giannini, S., Alendronate improves screw fixation in osteoporotic bone (2007) J Bone Joint Surg Am, 89, pp. 96-101
Hilding, M., Ryd, L., Toksvig-Larsen, S., Aspenberg, P., Clodronate prevents prosthetic migration: A randomized radiostereometric study of 50 total knee patients (2000) Acta Orthop Scand, 71, pp. 553-557
Hilding, M., Aspenberg, P., Postoperative clodronate decreases prosthetic migration: 4-year follow-up of a randomized radiostereometric study of 50 total knee patients (2006) Acta Orthop, 77, pp. 912-916
Sumner, D.R., Turner, T.M., Purchio, A.F., Gombotz, W.R., Urban, R.M., Galante, J.O., Enhancement of bone ingrowth by transforming growth factor-beta (1995) J Bone Joint Surg Am, 77, pp. 1135-1147
Sumner, D.R., Turner, T.M., Urban, R.M., Virdi, A.S., Inoue, N., Additive enhancement of implant fixation following combined treatment with rhTGF-beta2 and rhBMP-2 in a canine model (2006) J Bone Joint Surg Am, 88, pp. 806-817
Skoglund, B., Holmertz, J., Aspenberg, P., Systemic and local ibandronate enhance screw fixation (2004) J Orthop Res, 22, pp. 1108-1113
Tanzer, M., Karabasz, D., Krygier, J.J., Cohen, R., Bobyn, J.D., Bone augmentation around and within porous implants by local bisphosphonate elution (2005) Clin Orthop Relat Res, 441, pp. 30-39
Tengvall, P., Skoglund, B., Askendal, A., Aspenberg, P., Surface immobilized bisphosphonate improves stainless-steel screw fixation in rats (2004) Biomaterials, 25, pp. 2133-2138
European Medicines Agency, Committee for Medicinal Products for Human Use. Post-authorisation summary of opinion for Inductos. 2005 Feb 17. EMEA/57906/2005. http://www.emea.europa.eu/pdfs/human/opinion/5790605en.pdf. Accessed 2007 Nov 1
Fairbank, J.C., Pynsent, P.B., The Oswestry Disability Index (2000) Spine, 25, pp. 2940-2952
Boden, S.D., Zdeblick, T.A., Sandhu, H.S., Heim, S.E., The use of rhBMP-2 in interbody fusion cages. Definitive evidence of osteoinduction in humans: A preliminary report (2000) Spine, 25, pp. 376-381
Gustilo, R.B., Anderson, J.T., Prevention of infection in the treatment of one thousand and twenty-five open fractures of long bones. Retrospective and prospective analyses (1976) J Bone Joint Surg, 58, pp. 453-458
Gustilo, R.B., Mendoza, R.M., Williams, D.N., Problems in the management of type III (severe) open fractures. A new classification of type III open fractures (1984) J Trauma, 24, pp. 742-746
Govender S, Csimma C, Genant HK, Valentin-Opran A, Amit Y, Arbel R, Aro H, Atar D, Bishay M, Borner MG, Chiron P, Choong P, Cinats J, Courtenay B, Feibel R, Geulette B, Gravel C, Haas N, Raschke M, Hammacher E, van der Velde D, Hardy P, Holt M, Josten C, Ketterl RL, Lindeque B, Lob G, Mathevon H, McCoy G, Marsh D, Miller R, Munting E, Oevre S, Nordsletten L, Patel A, Pohl A, Rennie W, Reynders P, Rommens PM, Rondia J, Rossouw WC, Daneel PJ, Ruff S, Ruter A, Santavirta S, Schildhauer TA, Gekle C, Schnettler R, Segal D, Seiler H, Snowdowne RB, Stapert J, Taglang G, Verdonk R, Vogels L, Weckbach A, Wentzensen A, Wisniewski T
BMP-2 Evaluation in Surgery for Tibial Trauma (BESTT) Study Group. 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 Joint Surg Am. 2002
84:2123-34
European Medicines Agency, Committee for Medicinal Products for Human Use. European Public Assessment Report (EPAR): Osigraft. EMEA/H/C/393. http://www.emea.europa.eu/humandocs/PDFs/EPAR/osigraft/039301en1.pdf. Accessed 2007 Nov 1
Friedlaender GE, Perry CR, Cole JD, Cook SD, Cierny G, Muschler GF, Zych GA, Calhoun JH, LaForte AJ, Yin S. Osteogenic protein-1 (bone morphogenetic protein-7) in the treatment of tibial nonunions. J Bone Joint Surg Am. 2001
83 Suppl 1(Pt 2):S151-8
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. Official J European Commun. L 169, 12.7.93, 1993
Grainger, A.J., Duryea, J., Elliott, J.M., Genant, H.K., The evaluation of a new digital semi-automated system for the radiological assessment of distal radial fractures (2002) Skeletal Radiol, 31, pp. 457-463
Lynch, J.A., Grigoryan, M., Fierlinger, A., Guermazi, A., Zaim, S., MacLean, D.B., Genant, H.K., Measurement of changes in trabecular bone at fracture sites using X-ray CT and automated image registration and processing (2004) J Orthop Res, 22, pp. 362-367
Madanat, R., Moritz, N., Larsson, S., Aro, H.T., RSA applications in monitoring of fracture healing in clinical trials (2006) Scand J Surg, 95, pp. 119-127
Fitzpatrick, R., Davey, C., Buxton, M.J., Jones, D.R., Evaluating patient-based outcome measures for use in clinical trials (1998) Health Technol Assess, 2 (I-IV), pp. 1-74
Harris, J.E., MacDermid, J.C., Roth, J., The International Classification of Functioning as an explanatory model of health after distal radius fracture: A cohort study (2005) Health Qual Life Outcomes, 3, p. 73
Reflection paper on the regulatory guidance for the use of health-related quality of life (HRQL) measures in the evaluation of medicinal products (2005) London: European Medicines Agency, , http://www.emea.europa.eu/pdfs/human/ewp/13939104en.pdf, Committee for Medicinal Products for Human Use CHMP, Accessed 2007 Aug 31
