Efficacy and safety of vertebroplasty for treatment of painful osteoporotic vertebral fractures : a randomised double-blind placebo-controlled trial

Buchbinder, R., Osborne, R.H., Wark, J.D., Mitchell, P., Wriedt, C., Graves, S., Staples, M. and Murphy, B. 2009, Efficacy and safety of vertebroplasty for treatment of painful osteoporotic vertebral fractures : a randomised double-blind placebo-controlled trial, Internal Medicine Journal, vol. 39, no. suppl 2, pp. A46-A46.


Title Efficacy and safety of vertebroplasty for treatment of painful osteoporotic vertebral fractures : a randomised double-blind placebo-controlled trial
Author(s) Buchbinder, R.
Osborne, R.H.
Wark, J.D.
Mitchell, P.
Wriedt, C.
Graves, S.
Staples, M.
Murphy, B.
Journal name Internal Medicine Journal
Volume number 39
Issue number suppl 2
Start page A46
End page A46
Publisher Wiley - Blackwell Publishing Asia
Place of publication Milton, Qld
Publication date 2009-05
ISSN 1444-0903
1445-5994
Summary Background: Vertebroplasty has become a common treatment for painful osteoporotic vertebral fractures despite limited evidence to support its use. The primary aim of this study was to determine its short-term efficacy and safety in this patient population.

Methods
: In a multicentre randomized placebo-controlled trial, participants with one or two painful osteoporotic vertebral fractures < 12 months duration confirmed active by MRI were randomly assigned, stratified by center, gender and duration of symptoms (< or ≥ 6 weeks), to receive vertebroplasty or sham treatment. Primary outcome was overall pain (0–10 scale) at 3 months. Participants, investigators (other than the interventional radiologist) and outcome assessors were blinded to treatment assignment.

Results: 78 participants were enrolled and 73 (36/38 active, 37/40 placebo, 94%) completed 3-month follow up. Vertebroplasty did not show any statistically significant advantage in any measured outcome with 95% confidence intervals indicating no plausible practically important benefits of vertebroplasty over placebo. At 1 week, 1 and 3 months, there were significant improvements in overall pain in both treatment groups (mean improvement (SD): 1.5 (2.5), 2.1 (2.8), 2.3 (2.6), and 1.7 (3.3), 2.5 (2.9), 1.9 (3.4) in the active and placebo groups respectively). Similar improvements in both groups were observed for night and rest pain, function, quality of life and perceived improvement. Eight incident clinical vertebral fractures (3 active, 5 placebo) occurred during 3-month follow up.

Conclusion
: We found no evidence of a beneficial effect of vertebroplasty over sham treatment for painful osteoporotic vertebral fractures, 1 week, 1 and 3 months following treatment. [Australian Clinical Trial Register number, ACTRN012605000079640]
Notes Abstract number : C32
Language eng
Field of Research 110399 Clinical Sciences not elsewhere classified
Socio Economic Objective 970111 Expanding Knowledge in the Medical and Health Sciences
HERDC Research category C2.1 Other contribution to refereed journal
Copyright notice ©2009, Royal Australasian College of Physicians
Persistent URL http://hdl.handle.net/10536/DRO/DU:30021884

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