A Interventional Study in a Real Life Setting to Assess the Clinical Efficacy and Effect on Fracture in the 1 Year after Injection of Zoledronic Acid in Osteoporotic Patients with Long Bone or Spine, Pelvic Fractures

Jaewon Lee; Joonguk Kim; Byeungjik Kang; Jaedong Kim; Ki-Chul Park; Ye-Soo Park

doi:10.4055/jkoa.2016.51.4.320

Journal List > J Korean Orthop Assoc > v.51(4) > 1013461

Go to TopGo to Top Go to BottomGo to Bottom

TOOLS

Lee, Kim, Kang, Kim, Park, and Park: A Interventional Study in a Real Life Setting to Assess the Clinical Efficacy and Effect on Fracture in the 1 Year after Injection of Zoledronic Acid in Osteoporotic Patients with Long Bone or Spine, Pelvic Fractures

Original Article

Journal of the Korean Orthopaedic Association 2016; 51(4): 320-326.

Published online: 11 August 2016

DOI: https://doi.org/10.4055/jkoa.2016.51.4.320

A Interventional Study in a Real Life Setting to Assess the Clinical Efficacy and Effect on Fracture in the 1 Year after Injection of Zoledronic Acid in Osteoporotic Patients with Long Bone or Spine, Pelvic Fractures

Jaewon Lee, M.D., Joonguk Kim, M.D., Byeungjik Kang, M.D., Jaedong Kim, M.D., Ki-Chul Park, M.D., Ye-Soo Park, M.D.

Department of Orthopedic Surgery, Hanyang University Guri Hospital, Hanyang University College of Medicine, Guri, Korea.

Correspondence to: Ye-Soo Park, M.D. Department of Orthopedic Surgery, Hanyang University Guri Hospital, 153 Gyeongchun-ro, Guri 11923, Korea. TEL: +82-31-560-2316, FAX: +82-31-560-2312, hyparkys@hanyang.ac.kr

Received 2 December 2015 Revised 25 January 2016 Accepted 16 February 2016

(open-access):

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Purpose

We studied the improvement of back pain in vertebral fracture and fracture healing in non-vertebral fracture after treatment with zoledronate in postmenopausal patients.

Materials and Methods

Postmenopausal women with bone mineral density (BMD) T-score of -2.5 or less and existing vertebral fractures or non-vertebral fractures between January 2011 and June 2012 were included. Patients received a single intravenous infusion of zoledronate within 3 days after diagnosis of fractures. The primary outcome was BMD and secondary outcomes were visual analogue scale (VAS) for back pain, fracture healing, and new clinical fracture.

Results

T-score increased significantly in the vertebral fracture group (n=97) and non-vertebral fracture group (n=31) at 1 year (p<0.05). The average VAS for back pain decreased significantly in the vertebral fracture group (p<0.05) and there was no delayed union, nonunion in the non-vertebral fracture group. There was no re-fracture and 3 new clinical fractures (2.34%) occurred during the follow-up period.

Conclusion

Zoledronate, as treatment in postmenopausal osteoporosis patients can improve BMD, reduce back pain in vertebral fracture, and has no negative effect on bone healing after fracture in non-vertebral fracture.

Keywords: osteoporosis, zoledronate, bone mineral density, back pain, fracture healing

Figures and Tables

Figure 1

Patient enrollment.

Figure 2

Change of back pain (VAS) in patients with vertebral fracture. VAS, visual analogue scale.

Table 1

Change of BMD

Values are presented as mean±standard deviation. BMD, bone mineral density.

Table 2

Change of Back Pain (VAS) in Vertebral Fracture Group Who Didn't Have Vertebroplasty (n=71)

Values are presented as mean±standard deviation. VAS, visual analogue scale.

Table 3

Adverse Events in Zoledronate Treated Patients (n=253)

Notes

This study is supported with research funding from the Novartis.

^{CONFLICTS OF INTEREST} The authors have nothing to disclose.

References

1. Rogers MJ. New insights into the molecular mechanisms of action of bisphosphonates. Curr Pharm Des. 2003; 9:2643–2658.

2. Cramer JA, Amonkar MM, Hebborn A, Altman R. Compliance and persistence with bisphosphonate dosing regimens among women with postmenopausal osteoporosis. Curr Med Res Opin. 2005; 21:1453–1460.

3. Downey TW, Foltz SH, Boccuzzi SJ, Omar MA, Kahler KH. Adherence and persistence associated with the pharmacologic treatment of osteoporosis in a managed care setting. South Med J. 2006; 99:570–575.

4. Lyles KW, Colón-Emeric CS, Magaziner JS, et al. HORIZON Recurrent Fracture Trial. Zoledronic acid and clinical fractures and mortality after hip fracture. N Engl J Med. 2007; 357:1799–1809.

5. Black DM, Delmas PD, Eastell R, et al. HORIZON Pivotal Fracture Trial. Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis. N Engl J Med. 2007; 356:1809–1822.

6. Lee JH, Lee J, Seo WS, Park YS. Analysis of adherence of once-yearly intravenous zolendronic acid for osteoporosis. Osteoporosis. 2014; 12:22–29.

7. Morshed S, Corrales L, Genant H, Miclau T 3rd. Outcome assessment in clinical trials of fracture-healing. J Bone Joint Surg Am. 2008; 90:Suppl 1. 62–67.

8. Reid IR, Brown JP, Burckhardt P, et al. Intravenous zoledronic acid in postmenopausal women with low bone mineral density. N Engl J Med. 2002; 346:653–661.

9. Peter CP, Cook WO, Nunamaker DM, Provost MT, Seedor JG, Rodan GA. Effect of alendronate on fracture healing and bone remodeling in dogs. J Orthop Res. 1996; 14:74–79.

10. 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. J Bone Miner Res. 2007; 22:867–876.

11. Colón-Emeric C, Nordsletten L, Olson S, et al. HORIZON Recurrent Fracture Trial. Association between timing of zoledronic acid infusion and hip fracture healing. Osteoporos Int. 2011; 22:2329–2336.

12. Kim TY, Ha YC, Kang BJ, Lee YK, Koo KH. Does early administration of bisphosphonate affect fracture healing in patients with intertrochanteric fractures? J Bone Joint Surg Br. 2012; 94:956–960.

13. Rozental TD, Vazquez MA, Chacko AT, Ayogu N, Bouxsein ML. Comparison of radiographic fracture healing in the distal radius for patients on and off bisphosphonate therapy. J Hand Surg Am. 2009; 34:595–602.

14. Gong HS, Song CH, Lee YH, Rhee SH, Lee HJ, Baek GH. Early initiation of bisphosphonate does not affect healing and outcomes of volar plate fixation of osteoporotic distal radial fractures. J Bone Joint Surg Am. 2012; 94:1729–1736.

15. Diamond TH, Champion B, Clark WA. Management of acute osteoporotic vertebral fractures: a nonrandomized trial comparing percutaneous vertebroplasty with conservative therapy. Am J Med. 2003; 114:257–265.

16. Garfin SR, Yuan HA, Reiley MA. New technologies in spine: kyphoplasty and vertebroplasty for the treatment of painful osteoporotic compression fractures. Spine. 2001; 26:1511–1515.

17. Gangji V, Appelboom T. Analgesic effect of intravenous pamidronate on chronic back pain due to osteoporotic vertebral fractures. Clin Rheumatol. 1999; 18:266–267.

18. Nevitt MC, Thompson DE, Black DM, et al. Fracture Intervention Trial Research Group. Effect of alendronate on limited-activity days and bed-disability days caused by back pain in postmenopausal women with existing vertebral fractures. Arch Intern Med. 2000; 160:77–85.

19. Dolan AL, Ryan PJ, Arden NK, et al. The value of SPECT scans in identifying back pain likely to benefit from facet joint injection. Br J Rheumatol. 1996; 35:1269–1273.

20. Manicourt DH, Altman RD, Williams JM, et al. Treatment with calcitonin suppresses the responses of bone, cartilage, and synovium in the early stages of canine experimental osteoarthritis and significantly reduces the severity of the cartilage lesions. Arthritis Rheum. 1999; 42:1159–1167.

21. Van Offel JF, Schuerwegh AJ, Bridts CH, Bracke PG, Stevens WJ, De Clerck LS. Influence of cyclic intravenous pamidronate on proinflammatory monocytic cytokine profiles and bone density in rheumatoid arthritis treated with low dose prednisolone and methotrexate. Clin Exp Rheumatol. 2001; 19:13–20.

22. Varenna M, Zucchi F, Ghiringhelli D, et al. Intravenous clodronate in the treatment of reflex sympathetic dystrophy syndrome. A randomized, double blind, placebo controlled study. J Rheumatol. 2000; 27:1477–1483.

23. Frost HM. Personal experience in managing acute compression fractures, their aftermath, and the bone pain syndrome, in osteoporosis. Osteoporos Int. 1998; 8:13–15.

24. Lee SH, Na WC, Park YK. Effect of intravenous administration of bisphosphonate for patients operatively treated for osteoporotic hip fracture. Hip Pelvis. 2012; 24:133–138.

25. Greenspan SL, Perera S, Ferchak MA, Nace DA, Resnick NM. Efficacy and safety of single-dose zoledronic acid for osteoporosis in frail elderly women: a randomized clinical trial. JAMA Intern Med. 2015; 175:913–921.

26. Boonen S, Reginster JY, Kaufman JM, et al. Fracture risk and zoledronic acid therapy in men with osteoporosis. N Engl J Med. 2012; 367:1714–1723.

TOOLS

Similar articles