title: Metabolic and clinical effects of ipriflavone in established post-menopausal osteoporosis.
abstract: Twenty patients with post-menopausal osteoporosis were randomly divided into two groups of ten patients and treated under double-blind conditions with ipriflavone (Osteofix) or placebo. The dosage was 600 mg/day given in three doses and treatment lasted 6 months. All the patients received an oral calcium supply (1 g per day). At baseline and then after 3 and 6 months, the following parameters were controlled: bone mineral content at the lumbar spine, distal radius and femoral shaft; parameters of bone metabolism (alkaline phosphatase, PTH, osteocalcin, calcitonin, calciuria and hydroxyprolinuria); clinical conditions (pain at rest and on movement, motility). Ipriflavone facilitated the conservation of bone mass, that increased in one of the tested areas (distal radius). On the contrary, a bone mineral loss was found in the group treated with placebo, which was significant in the spine. Pain and motility significantly improved in the group treated with ipriflavone; there was an initial improvement in the control group, followed by a sharp worsening. The parameters investigated showed a significant reduction of osteocalcin in the ipriflavone group that indicates a modulation on bone turnover. The drug was well tolerated and compliance to oral treatment was excellent.
authors.affiliation: Institute of Medical Semeiotics, University of Siena, Italy.
authors.forename: D
authors.initials: D
authors.lastname: Agnusdei
authors.forename: F
authors.initials: F
authors.lastname: Zacchei
authors.forename: S
authors.initials: S
authors.lastname: Bigazzi
authors.forename: C
authors.initials: C
authors.lastname: Cepollaro
authors.forename: P
authors.initials: P
authors.lastname: Nardi
authors.forename: M
authors.initials: M
authors.lastname: Montagnani
authors.forename: C
authors.initials: C
authors.lastname: Gennari
mesh_terms: D001842:Bone and Bones / Q000378:metabolism*; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D005260:Female; D005419:Flavonoids / Q000627:therapeutic use*; D006801:Humans; D007529:Isoflavones / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D010024:Osteoporosis / Q000188:drug therapy* / Q000378:metabolism; D010146:Pain / Q000209:etiology; D011897:Random Allocation
chemical_list: D005419:Flavonoids; D007529:Isoflavones; C018986:ipriflavone