Efficacy and safety of ossein-hydroxyapatite complex versus calcium carbonate to prevent bone loss.

Objective: This study aimed to compare the efficacy and safety of ossein-hydroxyapatite complex (OHC) versus calcium carbonate (CC) for preventing bone loss during perimenopause in current clinical practice.Methods: The prospective, comparative, non-randomized, open-label study included 851 perimenopausal women with basal bone mineral density (BMD) T-score ≥-2 standard deviations (SDs). Participants received either OHC (712 mg calcium/day) or CC (1000 mg calcium/day) over 3 years. BMD was evaluated by dual-energy X-ray absorptiometry at the lumbar spine (L2-L4) at baseline and after 18 and 36 months of follow-up. Adverse drug reactions (ADRs) were also recorded.Results: In women receiving OHC, BMD at the L2-L4 site remained stable over the 3-year follow-up period (mean [SD] change 0.00 [0.11] g/cm2). BMD in the CC arm decreased -3.1% (mean [SD] - 0.03 [0.11] g/cm2). Between-group differences were statistically significant (p < 0.001) and favored OHC. ADRs were more frequent in the CC group (7.7% vs. 2.7% in the OHC group; p = 0.001), affecting primarily the gastrointestinal system.Conclusion: OHC showed greater efficacy and tolerability than CC for bone loss prevention in perimenopausal women in real-world practice. As the daily dose of calcium was higher in the CC group, the differences might be linked to the ossein compound in OHC.

Isoflavones: effects on bone health.

BACKGROUND: There are many effects described, both experimental and clinical, that assess the relationship between isoflavones and bone. It has been hypothesized that isoflavones may have a positive effect on bone health. OBJECTIVE: To review the effects of isoflavones on biochemical markers of bone remodeling, bone density and bone quality, and finally on fracture incidence. METHODS: A systematic review was carried out of in vitro, animal, and human studies involving isoflavones and bone health. An electronic search was made, based on Internet search engines, MEDLINE (1966-June 2010) and the Cochrane Controlled Clinical Trials Register. This search was further supplemented by a hand-search of reference lists of selected review papers. RESULTS: After crossing-cleaning the reference lists, 737 studies dealing with isoflavones and bone were identified. Of these, 36 were considered selectable. From in vitro and animal studies, isoflavones appear to stimulate osteoblastic bone formation and inhibit osteoclastic bone resorption. Reviewed data show evidence of a beneficial effect of isoflavones on bone health in peri- and postmenopausal women when high-isoflavone soy protein is incorporated in the diet. Inconsistencies observed among data from different studies are related to differences in study design, the variety of soy sources of isoflavones, time of analysis, and the variability in the bioavailability and metabolism of isoflavones. CONCLUSIONS: Most of the studies suggested a positive relationship between isoflavones and bone health. Further well-controlled, randomized, double-blind, clinical trials with a larger sample population, longer duration, and examination of various dosages are needed to better elucidate the inter-relationship between isoflavones and bone loss and to clarify whether isoflavones could prevent bone fractures.

Effect of a compound containing isoflavones, primrose oil and vitamin E in two different doses on climacteric symptoms.

The object of this study was to evaluate the effect of different doses of a compound containing isoflavones 60 mg, primrose oil 440 mg and vitamin E 10 mg. (IOVE) on menopausal complaints. This was an open, multicentre, randomised, group comparative, efficacy and safety trial. A total of 1,080 postmenopausal women, with climacteric symptoms, were allocated into one of two treatment groups to receive one (Group 1; n = 562) or two IOVE capsules (Group 2; n = 518) per day. The Blatt - Kupperman scale and safety parameters including weight, body mass index, blood pressure and adverse effects were assessed at the first visit before initiating the treatment, and 3 - 6 months thereafter. In addition, cholesterol, high density lipoprotein (HDL), low-density lipoprotein (LDL) and triglyceride levels were measured at baseline and at the 6th month visit. Finally, at the end of follow-up, the patient's satisfaction was assessed. No differences between groups at the beginning of the study and during the follow-up were observed. A significant reduction in Blatt - Kupperman scores were observed in the two groups. In addition, the reduction of the symptoms was more intense in the first 3 months. Increasing doses of IOVE add no beneficial effects since both studied doses were equally effective in the reduction of climacteric complaints.