Correlation between zoledronic acid infusion and repeat vertebroplasty surgery in osteoporotic patients

Abstract

Objective The incidence of bone fractures rapidly increases as people age, mostly due to bone loss resulting from osteoporosis. The purpose of this study is to compare the rates of repeat vertebroplasty in osteoporotic patients treated with or without zoledronic acid (ZOL) infusion following initial vertebroplasty.

Research design and methods We conducted a retrospective chart review of osteoporotic patients who underwent vertebroplasty from June 2009 to June 2012. Patients with existing vertebral fracture(s) were retrospectively divided into two groups according to whether or not they received zoledronic acid infusion after initial vertebroplasty. Zoledronic acid infusion was intravenously administered once a year for three consecutive years, as a single 5 mg dose in 100 mL solution infused over at least 15 minutes. The primary efficacy variable was the number of patients requiring repeat vertebroplasty procedures after the initial surgery due to subsequent vertebral fractures. The Cox proportional hazards model was used to compare the risk ratios of repeat vertebroplasty between these two groups.

Results A total of 1646 patients, including 456 males and 1190 females (age range: 65–89 years), were enrolled. Compared to the 1595 patients who did not receive osteoporosis medication, the 51 patients treated with zoledronic acid infusion demonstrated a significantly lower rate of repeat vertebroplasty. In the ZOL-treated group, only 4% of the patients (2/51) required a second vertebroplasty, compared to 13% (206/1595) in the non-ZOL-treated group (p = 0.032).

Conclusions The results indicate that osteoporotic patients who undergo vertebroplasty are significantly less likely to require reoperation if treated with zoledronic acid infusion. However, since the number of male patients in the ZOL-treated group was limited, and since Taiwan’s National Health System program does not cover the cost of receiving zoledronic acid infusions for male patients, the conclusion seems to be less certain for male osteoporotic patients.

Keywords:

• Bisphosphonates
• Bone fractures
• Osteoporosis
• Vertebroplasty

Declaration of funding

This study was supported by Chang Gung Memorial Hospital in Taoyuan, Taiwan, under grant number CMRPG3E0591.

Declaration of financial/other relationships

T.-Y.L., S.-C.Y., T.-T.T., P.-L.L., T.-S.F., C.-C.N., L.-H.C., and W.-J.C. have disclosed that they have no significant relationships with or financial interests in any commercial companies related to this study or article.

CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Acknowledgments

We thank the Statistics Center for Clinical Research, Chang Gung Memorial Hospital, Taoyuan, Taiwan, for providing statistical analysis support.

Notes

*Ultracet, a tablet combines 37.5 mg tramadol hydrochloride and 325 mg acetaminophen, Janssen Korea, Ltd., Korea.

†Aclasta is a registered trade name of Novartis, Taiwan.