The Use of Placebo-Controlled and Non-inferiority Trials for the Evaluation of New Drugs in the Treatment of Postmenopausal Osteoporosis

Abstract

Registration of new agents for the treatment of postmenopausal osteoporosis has been based over the past few years on placebo-controlled phase III trials with the incidence of patients with new vertebral/nonvertebral fractures as the most usual primary endpoint. The use of a placebo in diseases where an active treatment is available has been a matter of… (More)
DOI: 10.1007/s198-002-8331-3

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@article{Delmas2002TheUO, title={The Use of Placebo-Controlled and Non-inferiority Trials for the Evaluation of New Drugs in the Treatment of Postmenopausal Osteoporosis}, author={Ph. Delmas and Guillermo Calvo and Miranda Boers and Eric C Abadie and Bernard P Avouac and Andr{\'e} Kahan and Judith Kaufman and Andrea Laslop and J F F Frits Lekkerkerker and Peter Nilsson and Barbara van Zwieten-Boot and Gunter Kreutz and Jean Yves L Reginster}, journal={Osteoporosis International}, year={2002}, volume={13}, pages={1-5} }