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Ibandronate and prevention of postmenopausal osteoporosis
  1. M Maravic1,
  2. P Landais1
  1. 1Hôpital Necker Enfants Malades (APHP), France
  1. Correspondence to:
    Dr M Maravic
    149 rue de Sèvres Paris Cedex 15, France75743; milka-maravicnoos.fr

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Stakkestad et al reported a clinical trial where intravenous (IV) ibandronate injections, given every 3 months during 1 year, produced a dose dependent gain in mean (SD) lumbar spine bone mineral density (BMD) compared with placebo in prevention of bone loss in postmenopausal women.1 The treatment was then proposed as an alternative to oral bisphosphonates and hormonal therapy in preventing postmenopausal osteoporosis.

The primary outcome was the relative change from baseline in lumbar BMD after 2 years of treatment tested by analysis of variance, with treatment group and stratum as independent variables. We found several limitations.

Firstly, the initial study was planned for 2 years, but was stopped at 12 months because of the interesting results of the IV ibandronate pivotal phase III fracture study.2 Was it possible to infer that results obtained from a trial on fracture occurrence would apply to the study of BMD?

Secondly, given the limited changes in BMD, it could be suggested that they might be due to random variability in the procedure. The least significant change (LSC) in BMD is the percentage of change that is unlikely to be due to the precision error of the procedure. The LSC is 2.8-fold the precision error of the procedure on a specific device, site of measurement, and number of measurements.3 Precision error was not evaluated in the study. The sample size was calculated with an expectation of a significant change in lumbar spine BMD of 3% compared with placebo after 2 years of treatment. Would …

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