leuprolide and ipriflavone

The purpose of this study was to evaluate the efficacy of ipriflavone in preventing bone loss, decreasing in serum cholesterol and decreasing the rate of appearance of vasomotor symptoms, as well as the effects of ipriflavone on reduction of myoma volume by estrogen deficiency during treatment with the GnRH analog leuprolide. One hundred two women (mean age, 44.3 +/- 0.53 yr) receiving leuprolide therapy for uterine leiomyoma were randomly allocated to two groups (group A, leuprolide only; group B, leuprolide with ipriflavone). Bone mineral density of the lumbar spine was measured by dual-energy x-ray absorptiometry before and after treatment for 6 months. Levels of serum total cholesterol (TC), triglyceride (TG), high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol (LDL-C) were measured before treatment and after 3 and 6 months of treatment. Subjects were asked to report the appearance of vasomotor symptoms throughout treatment. Myoma node volumes were measured before treatment and after treatment for 6 months. Bone mineral density was reduced in both groups, with reduction rates of -5.26% in group A and -3.70% in group B (P < 0.01 vs. group A). Changes in bone markers were not significant in either group. TC was significantly increased in both groups, and TG levels were increased significantly after 3 and 6 months of treatment in group A but not in group B. There was no significant difference between these two groups in amount of increase of either TC or TG. LDL-C levels were increased significantly after 3 and 6 months of treatment in both groups, and the differences between the groups (11.7% in group A vs. 7.5% in group B at 3 month and 22.6% in group A vs. 8.4% in group B at 6 month) were significant. Severe vasomotor symptoms were reduced in group B. The rates of reduction of myoma volume were 49.8% in group A and 52.9% in group B; this difference between groups was not significant. Ipriflavone efficaciously alleviated the adverse effects of estrogen deficiency such as bone loss and increase in LDL-C level, and the ability of leuprolide therapy to reduce myoma volume was not decreased by ipriflavone administration.

Topics: Adult; Bone Density; Cholesterol; Cholesterol, HDL; Cholesterol, LDL; Estrogen Antagonists; Female; Humans; Isoflavones; Leiomyoma; Leuprolide; Middle Aged; Osteoporosis; Triglycerides; Uterine Neoplasms

In a double-blind, placebo controlled study, ipriflavone (600 mg/day, T.D.D.) or identical placebo tablets were given with 500 mg/day of calcium to patients treated with the gonadotropin hormone-releasing hormone agonist (Gn-RH-A) leuproreline acetate, 3.75 mg every 30 days for 6 months. In placebo-treated subjects (n = 39), urinary hydroxyproline excretion and plasma osteocalcin levels showed a significant (P < 0.01 and P < 0.05, respectively) increase, whereas spine bone density and total body bone density significantly (P < 0.001 and P < 0.05, respectively) decreased after 3 and 6 months of GnRH-A administration. Conversely, in the ipriflavone-treated group (n = 39), no significant difference in bone markers and bone density was evidenced. These data indicate that ipriflavone can restrain the bone remodeling processes and prevent the rapid bone loss that follows medically induced hypogonadism.

Topics: Absorptiometry, Photon; Analysis of Variance; Antineoplastic Agents, Hormonal; Bone Density; Bone Remodeling; Female; Follow-Up Studies; Gonadotropin-Releasing Hormone; Humans; Hypogonadism; Isoflavones; Leiomyoma; Leuprolide; Lumbar Vertebrae; Menopause; Metrorrhagia; Osteoporosis, Postmenopausal; Treatment Outcome; Uterine Neoplasms; Uterus

The aim of this study is to evaluate the association between GnRH analogues and ipriflavone, drug modulating the bone turnover limiting the negative bone effects of analogue. Thirty patients (33 +/- 5.4 years, mean +/- SD) affect by benign gynecological conditions in which there was an indication to use GnRH analogs have been treated with leuprolide acetate at the monthly intramuscular dose of 3.75 mg, for six months. Fifteen of these patients also received 600 mg/day per os of ipriflavone (group A), while the other 15 patients have been treated exclusively with leuprolide acetate (group B). Before and after treatment, radial bone mineral density (BMD) and main markers of bone turnover were measured in all patients. Before treatment no difference in the considered parameters could be detected between the two groups. In group A, after 6 months of treatment no significant decrease in BMD and no variations in the bone turnover parameters. On the contrary, in group B, after six months of treatment, a significant decrease (p < 0.05) in BMD was observed in comparison to basal and group A values. In the same group alkaline phosphatase, osteocalcin and urinary calcium/creatinine and hydroxyproline/creatinine ratio proved significantly increased in comparison to basal and group A values (both with p < 0.05). Ipriflavone, therefore, seems to be effective in counteracting the negative effects of GnRH-a induced on bone.

Topics: Analgesics; Antineoplastic Agents, Hormonal; Bone Remodeling; Female; Genital Diseases, Female; Genital Neoplasms, Female; Humans; Isoflavones; Leuprolide; Osteoporosis; Time Factors

GnRH Analogues therapy of estrogen-dependent gynaecological diseases aims at suppression of physiologic ciclic ovaric function producing a hypogonadotropic condition. The first consequence of GnRH Analogues administration is hypoestrogenism; this condition permits the disease regression but, on the other, it causes a negative impact on bone metabolism particularly for prolonged therapeutic schemes (6 months). This study has evaluated the faculty of bone mass protection combining GnRH Analogues therapy with Ipriflavone that stimulates, both "in vivo" and "in vitro", Osteoblastic cells activity. The result of this study showed a significant bone loss in patients treated with GnRH Analogues only. The Ipriflavone association prevented bone loss.

Topics: Adult; Antineoplastic Agents, Hormonal; Bone Resorption; Female; Humans; Isoflavones; Leuprolide