Osteoporosis prevention clinical study program.
Menorest Closed Symposium. , 1994/10.
Oestrogens are widely believed to be effective against postmenopausal osteoporosis.
However there are some outstanding questions which still need an answer.
For example, the minimal effective dose regimen of oestradiol needs to be established and the relationship between oestradiol levels and efficacy on bone turnover and bone mass needs to be further clarified.
Menorest is being tested in the prevention of postmenopausal bone loss.
A phase II/III clinical program, that includes two double blind, dose-ranging, placebo-controlled, parallel group, 2-year studies, has started in 58 centers in Europe and South Africa.
Four-hundred eighty women will be enrolled in the two studies (201 and 305).
The objective of the studies is to evaluate the efficacy of Menorest at different doses and regimens, in the prevention of bone loss in early postmenopausal women.
In study 201, the treatment regimen is'cyclic sequential' (24 days of transdermal oestradiol during a 28-day cycle with progestin taken during the last 14 days of oestrogen administration).
In study 305 the treatment regimen is'continuous sequential' (28 days of transdermal oestradiol during, a 28-day cycle with progestin taken during the last 14 days of oestrogen administration).
The doses studied are 50,75,100 mug/day in study 201, and 25,50,75 mug/day in study 305, (the two studies are otherwise identical).
All'active-dose'treated groups receive dydrogesterone 20 mg/day during the las...
Mots-clés Pascal : Ostéoporose, Oestrogène, Prévention, Essai clinique, Efficacité traitement, Etude statistique, Homme, Femelle, France, Europe, Système ostéoarticulaire pathologie, Ostéopathie
Mots-clés Pascal anglais : Osteoporosis, Estrogen, Prevention, Clinical trial, Treatment efficiency, Statistical study, Human, Female, France, Europe, Diseases of the osteoarticular system, Bone disease
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Cote : 96-0250952
Code Inist : 002B15A. Création : 199608.