title: Bazedoxifene: literature data and clinical evidence.
abstract: A Multidisciplinary National Panel of Experts in the management of Menopause and Postmenopausal Osteoporosis was created to determine the specific positioning of Bazedoxifene acetate (BZA), a third-generation selective estrogen receptor modulator (SERM), in the field of available therapeutic options in prevention and treatment of postmenopausal osteoporosis.There are various therapeutic options in prevention and treatment for postmenopausal osteoporosis, but nevertheless the problem of osteoporosis and osteoporosis-related fractures is not yet resolved today.In view of this unmet medical need, to have new treatments with efficacy and safety profile so good to therapeutically manage even larger groups of population is the conceptual basis to reduce the devastating impact of this disease on individual's morbidity and mortality, and on public health expense.The Panel has, moreover, pointed up the need to increase the awareness about the issue "osteopenia" as a risk factor for fracture to consider in daily clinical practice and the opportunity to evaluate fracture risk using an adequate algorithm (for example, FRAX®, deFRA®), which integrates the result obtained by densitometry (Bone Mineral Density, BMD) (1, 2) and clinical risk factors, in order to consider threshold values for pharmacological intervention.As for prevention and treatment and different groups of age in women's life, it is evident as in the group ranging in age 50 to 65 years the reference Specialist may be the Gynecologist, as the Woman's doctor, even if other Specialists could be interested (Endocrinologist, Rheumatologist, Internist, General Practitioner, or other Specialist who is seeing a patient with osteopenia/osteoporosis). The involved Specialist, necessarily, has to make preventative and/or therapeutic strategies for osteopenia/osteoporosis.After the publication of the study Women's Health Initiative (WHI) in 2002 (3), there was a decrease in applying Hormonal Replacement Therapy (HRT) or Hormone Therapy (HT), that even if is prescribed for climacteric symptoms (hot flushes, night sweats, etc.) can prevent bone loss and reduce osteoporosis-related fracture risk. The lower use of HRT (HT) has increased and still increases the risk of developing, in postmenopausal women, osteopenia and osteoporosis, with increased fracture risk, as it is demonstrated by N.O.R.A. Study (National Osteoporosis Risk Assessment) published in 2004 (4).On the other hand, the different treatments available for osteoporosis therapy, significantly decrease the relative risk of osteoporosis, but the percentage of non-treated or under-treated patients remains high. Thus, it is still fundamental to have at disposal further treatments with proven efficacy in preventing and treating osteopenia and osteoporosis in everyday clinical practice.
authors.affiliation: Endocrinological Gynaecology Unit, Physiopathology of the Menopause and Osteoporosis, Dermopathic Institute of the Immacolata-IRCCS, Rome, Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: Lello
authors.forename: Maria Luisa
authors.initials: ML
authors.lastname: Brandi
authors.forename: Giovanni
authors.initials: G
authors.lastname: Minisola
authors.forename: Salvatore
authors.initials: S
authors.lastname: Minisola
authors.forename: Andrea Riccardo
authors.initials: AR
authors.lastname: Genazzani