arznei-telegramm 2009; 40: 91


Vertebroplasty for osteoporotic vertebral fractures no better than placebo: Painful vertebral fractures caused by osteoporosis are traditionally treated with analgesics and by immobilization. In recent years, vertebroplasty has become increasingly popular as a pain-relieving procedure. It involves injecting polymethylmethacrylate, so-called bone cement, into the vertebral body via a hollow needle. Although there has not yet been any valid proof of benefit from randomized controlled trials,* this procedure is widely used and recommended in guidelines on the basis of observational data. For the first time, two randomized controlled trials have now been published - an Australian trial and an international study (INVEST**) - in which vertebroplasty is compared blinded with sham treatment. A total of 78 patients are involved in the Australian trial and 131 in the international study. The majority (79% and 76% respectively) are women, and the mean age is over 70 years in both studies. Patients should not have been suffering from painful osteoporotic vertebral fractures for more than a year. In both clinical trials, the pain diminishes in the placebo group as well as the active treatment group. In both studies, however, intervention does not have a significantly positive effect on either the primary endpoint (pain intensity and in INVEST additionally disability after one or three months***) or secondary endpoints (BUCHBINDER, R. et al.: N. Engl. J. Med. 2009; 361: 557-68; KALLMES, D.F. et al.: N. Engl. J. Med. 2009; 361: 569-79, ati-d). Vertebroplasty is not without risk: there have been reports of injury to the dural sac, osteomyelitis, leakage of bone cement with nerve-root compression or systemic embolization and fractures of adjacent vertebral bodies resulting from altered statics. As short-term benefit compared with placebo treatment is not proven and there is a complete lack of randomized long-term studies, vertebroplasty is only justifiable in a clinical trial context in our opinion. This also applies to kyphoplasty, a related procedure involving the use of a balloon to elevate the vertebral body, for which only an unblinded randomized controlled short-term study exists so far (WARDLAW, D. et al.: Lancet 2009; 373: 1016-24), -Ed.



The only publications available to date were a randomized negative study with 50 patients (ROUSING, R. et al.: Spine 2009; 34: 1349-54) and a randomized trial with 34 patients which was discontinued prematurely because of a high crossover rate after two weeks (VOORMOLEN, M.H.J. et al.: Am. J. Neuroradiol. 2007; 28: 555-60). Both are unblinded trials.



INVEST = Investigational Vertebroplasty Safety and Efficacy Trial



Australian study: pain score (rating scale from 0 to 10 points) after three months decreased by 2.6 vs. 1.9 points, difference 0.6 (95% confidence interval [CI] -0.7 to 1.8); INVEST: score after one month for disability (modified Roland-Morris Disability Questionnaire, scale from 0 to 23 points) 12.0 vs. 13.0 points, effect 0.7 (95% CI -1.3 to 2.8) and for pain (scale from 0 to 10 points) 3.9 vs. 4.6 points, effect 0.7 (95% CI -0.3 to 1.7)

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