A local application of recombinant human fibroblast growth factor 2 for tibial shaft fractures: A randomized, placebo-controlled trial

Journal of Bone and Mineral Research

Volumn 25, Issue 12, 2010, Pages 2735-2743

  Kawaguchi, Hiroshi ^a   Oka, Hiroyuki ^a   Jingushi, Seiya ^b   Izumi, Toshihiro ^c   Fukunaga, Masao ^d   Sato, Katsumi ^e   Matsushita, Takashi ^f   Nakamura, Kozo ^a  

^a UNIVERSITY OF TOKYO   (Japan)

^b KYUSHU ROSAI HOSPITAL   (Japan)

^c Saihaku Hospital   (Japan)

^d KAWASAKI MEDICAL SCHOOL   (Japan)

^e TOHOKU ROSAI HOSPITAL   (Japan)

^f TEIKYO UNIVERSITY   (Japan)

Author keywords

Clinical Trial; Fibroblast Growth Factor; Fracture Healing

Indexed keywords

FIBROBLAST GROWTH FACTOR 2; PLACEBO;

ACUTE HEART INFARCTION; ADULT; AGED; ALKALINE PHOSPHATASE BLOOD LEVEL; ANEURYSM; ARTHRALGIA; ARTICLE; BACKACHE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG FEVER; DRUG MEGADOSE; EOSINOPHILIA; FEMALE; FRACTURE HEALING; HUMAN; HYPERLIPIDEMIA; INFECTION; INSOMNIA; INTRAMEDULLARY NAILING; LIMB PAIN; LIVER DYSFUNCTION; LOW DRUG DOSE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SIDE EFFECT; SKIN NECROSIS; SOFT TISSUE INFECTION; SYNCOPE; TIBIA SHAFT FRACTURE; URIC ACID BLOOD LEVEL;

EID: 78649581478     PISSN: 08840431     EISSN: None     Source Type: Journal    
DOI: 10.1002/jbmr.146     Document Type: Article

References (31)

1. Heckman JD, Sarasohn-Kahn J., The economics of treating tibia fractures: the cost of delayed unions. Bull Hosp Joint Dis. 1997; 56: 63-72.
2. Finkemeier CG, Schmidt AH, Kyle RF, Templeman DC, Varecka TF., A prospective, randomized study of intramedullary nails inserted with and without reaming for the treatment of open and closed fractures of the tibial shaft. J Orthop Trauma. 2000; 14: 187-193.
3. Younger EM, Chapman MW., Morbidity at bone graft donor sites. J Orthop Trauma. 1989; 3: 192-195.
4. Finkemeier CG., Bone-grafting and bone-graft substitutes. J Bone Joint Surg Am. 2002; 84: 454-464.
5. Bolander ME., Regulation of fracture repair by growth factors. Proc Soc Exp Biol Med. 1992; 200: 165-170.
6. Bourque WT, Gross M, Hall BK., Expression of four growth factors during fracture repair. Int J Dev Biol. 1993; 37: 573-579.
7. Lieberman JR, Daluiski A, Einhorn TA., The role of growth factors in the repair of bone biology and clinical applications. J Bone Joint Surg Am. 2002; 84: 1032-1044.
8. Itoh N, Ornitz DM., Evolution of the Fgf and Fgfr gene families. Trends Genet. 2004; 20: 563-569.
9. Ornitz DM., FGF signaling in the developing endochondral skeleton. Cytokine Growth Factor Rev. 2005; 16: 205-213.
10. Canalis E, Centrella M, McCarthy T., Effects of basic fibroblast growth factor on bone formation in vitro. J Clin Invest. 1988; 81: 1572-1577.
11. Khan SN, Bostrom MP, Lane JM., Bone growth factors. Orthop Clin North Am. 2000; 31: 375-388.
12. Kawaguchi H, Kurokawa T, Hanada K, et al. Stimulation of fracture repair by recombinant human basic fibroblast growth factor in normal and streptozotocin-diabetic rats. Endocrinology. 1994; 135: 774-781.
13. Nakamura K, Kawaguchi H, Aoyama I, et al. Stimulation of bone formation by intraosseous application of recombinant basic fibroblast growth factor in normal and ovariectomized rabbits. J Orthop Res. 1997; 15: 307-313. (Pubitemid 27220551)
14. Kato T, Kawaguchi H, Hanada K, et al. Single local injection of recombinant fibroblast growth factor-2 stimulates healing of segmental bone defects in rabbits. J Orthop Res. 1998; 16: 654-659.
15. Radomsky ML, Aufdemorte TB, Swain LD, et al. Novel formulation of fibroblast growth factor-2 in a hyaluronan gel accelerates fracture healing in nonhuman primates. J Orthop Res. 1999; 17: 607-614.
16. Tabata Y, Yamada K, Hong L, et al. Skull bone regeneration in primates in response to basic fibroblast growth factor. J Neurosurg. 1999; 91: 851-856.
17. Kawaguchi H, Nakamura K, Tabata Y, et al. Acceleration of fracture healing in non-human primates by fibroblast growth factor-2. J Clin Endocrinol Metab. 2001; 86: 875-880.
18. Kawaguchi H, Jingushi S, Izumi T, et al. Local application of recombinant human fibroblast growth factor-2 on bone repair: a dose-escalation prospective trial on patients with osteotomy. J Orthop Res. 2007; 25: 480-487.
19. Charles M, Court-Brown C., Fractures of the tibia and fibula. In:, Bucholz RW, Heckman JD, Court-Brown C, eds. Rockwood and Green's Fractures in Adults 6th ed. Philadelphia, USA: Lippincott Williams & Wilkins, 2079-2146. 2006.
20. Heckman JD, Ryaby JP, McCabe J, Frey JJ, Kilcoyne RF., Acceleration of tibial fracture-healing by non-invasive, low-intensity pulsed ultrasound. J Bone Joint Surg Am. 1994; 76: 26-34.
21. Freedman LS., Tables of the number of patients required in clinical trials using the logrank test. Stat Med. 1982; 1: 121-129.
22. Rodan SB, Wesolowski G, Kyonggeun Y, Rodan GA., Opposing effects of fibroblast growth factor and pertussis toxin on alkaline phosphatase, osteopontin, osteocalcin and type I collagen mRNA levels in ROS 17/2.8 cells. J Biol Chem. 1989; 264: 19934-19941.
23. Hurley MM, Abreu C, Harrison JR, et al. Basic fibroblast growth factor inhibits type I collagen gene expression in osteoblastic MC3T3-E1 cells. J Biol Chem. 1993; 268: 5588-5593.
24. Kawaguchi H, Pilbeam CC, Gronowicz G, et al. Transcriptional induction of prostaglandin G/H synthase-2 by basic fibroblast growth factor. J Clin Invest. 1995; 96: 923-930.
25. Nakajima A, Nakajima F, Shimizu S, et al. Spatial and temporal gene expression for fibroblast growth factor type I receptor (FGFR1) during fracture healing in the rat. Bone. 2001; 29: 458-466. (Pubitemid 33026467)
26. Noda M, Vogel R., Fibroblast growth factor enhances type ß1 transforming growth factor gene expression in osteoblast-like cells. J Cell Biol. 1989; 109: 2529-2535.
27. Gerstenfeld LC, Einhorn TA., COX inhibitors and their effects on bone healing. Expert Opin Drug Saf. 2004; 3: 131-136.
28. Gerstenfeld LC, Al-Ghawas M, Alkhiary YM, et al. Selective and nonselective cyclooxygenase-2 inhibitors and experimental fracture-healing. Reversibility of effects after short-term treatment. J Bone Joint Surg Am. 2007; 89: 114-125.
29. 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 Joint Surg Am. 2002; 84: 2123-2134.
30. Swiontkowski MF, Aro HT, Donell S, et al. Recombinant human bone morphogenetic protein-2 in open tibial fractures. A subgroup analysis of data combined from two prospective randomized studies. J Bone Joint Surg Am. 2006; 88: 1258-1265.
31. Liu G, Kawaguchi H, Ogasawara T, et al. Optimal combination of soluble factors for tissue engineering of permanent cartilage from cultured human chondrocytes. J Biol Chem. 2007; 282: 20407-20415.