Treatment of postmenopausal osteoporosis with parathyroid hormone (1-34) decreases the risk of vertebral and nonvertebral fractures; increases vertebral, femoral, and total-body bone mineral density; and is well tolerated. The 40-microg dose increased bone mineral density more than the 20-microg dose but had similar effects on the risk of fracture and was more likely to have side effects.
Supplementation with vitamin D can be achieved equally well with daily, weekly, or monthly dosing frequencies. Therefore, the choice of dose frequency can be based on whichever approach will optimize an individual's adherence with long-term vitamin D supplementation.
A follow-up in 1262 women was conducted after the discontinuation of teriparatide. The hazard ratio for combined teriparatide group (20 and 40 µg) for the 50-month period after baseline was 0.57 (p = 0.002), suggesting a sustained effect in reducing the risk of nonvertebral fragility fracture.Introduction: Treatment with teriparatide [rhPTH(1-34)] 20 and 40 g once-daily subcutaneous dosing significantly reduced the risk of nonvertebral fragility fractures over a median exposure of 19 months. Materials and Methods: All participants in the Fracture Prevention Trial were invited to participate in a follow-up study. Prior treatment assignments were revealed, and patients were able to receive osteoporosis treatments without restriction.Results: Approximately 60% of the 1262 patients received an osteoporosis treatment at some time during follow-up, with greater use in the former placebo group than in the combined former teriparatide group (p < 0.05). The hazard ratios for nonvertebral fragility fractures in each teriparatide group relative to placebo were statistically significant for the 50-month period including treatment and follow-up (p < 0.03). In the follow-up period, the hazard ratio was significantly different between the 40 g and combined groups versus placebo but not for the 20 g group versus placebo. However, the 20 and 40 g groups were not different from each other. Kaplan-Meier analysis of time to fracture showed that the fracture incidence in the former placebo and teriparatide groups diverged during the 50-month period including teriparatide treatment and follow-up (p ס 0.009). Total hip and femoral neck BMD decreased in teriparatide-treated patients who had no follow-up treatment; BMD remained stable or further increased in patients who received a bisphosphonate after teriparatide treatment. Conclusions: While the study design is observational, the results support a sustained effect of teriparatide in reducing the risk of nonvertebral fragility fractures up to 30 months after discontinuation of treatment.
We have previously introduced the potential of casein micelles (CM) as natural nanovehicles for hydrophobic nutraceuticals, e.g. vitamin D (VD) (E. Semo, E. Kesselman, D. Danino and Y. D. Livney, Food Hydrocolloids, 2007, 21, 936-942). The aims of the current study were to improve performance by adding an ultra-high-pressure homogenization step, and to evaluate the protection conferred by re-assembled CM (rCM) against VD thermal and oxidative degradation, and the bioavailability of VD(3) in rCM, by a clinical trial. Dynamic-light-scattering showed that VD(3)-rCM had a diameter of 91 ± 8 nm (average ± standard error). When VD(3) was encapsulated in rCM and subjected to thermal treatment (80 °C, 1 min), no significant loss was observed (P > 0.05), compared to 13 and 14% loss of VD(3) emulsified with Tween-80 (a synthetic emulsifier typically used for VD solubilization) and of unencapsulated VD(3) respectively (P < 0.05). VD(3) in rCM was also more stable during 28 d cold storage (∼40% loss) compared to Tween-80 emulsified (∼50% loss) or to un-encapsulated (∼70% loss) VD(3). Ultra-high-pressure homogenization of VD(3)-rCM (∼155 MPa) significantly enhanced vitamin stability, resulting in only ∼10% loss after 28 d of storage. Bioavailability of a single-dose of 50,000 international-units (IU) VD(3) encapsulated in rCM, in 1% fat milk, investigated in a randomized double blinded placebo controlled clinical study with 87 human volunteers, was at least as high as that using an aqueous Tween-80-emulsified VD(3) supplement. We conclude that ultra-high-pressure homogenization treated rCM protect VD(3) against heat- and storage-induced degradation, and VD(3) encapsulated in rCM is highly bioavailable.
The risk factors embodied in hyperinsulinaemia and enhanced bone turnover which, ultimately, have consequences for TS morbidity, are minimized by HRT. In the short term, neither regimen is effective for bone turnover in adult women with Turner syndrome.
BackgroundFlu-like symptoms (FLS) are common side effects of interferon beta (IFN-β) treatment in patients with Multiple Sclerosis (PwMS) and are associated with post-injection cytokine surge. We hypothesized that vitamin D3 supplementation would ameliorate FLS by decreasing related serum cytokines’ levels.MethodsIn a randomized, double blind study of 45 IFNβ-treated PwMS, 21 patients were assigned to 800 IU of vitamin D3 per day (low dose), while 24 patients received 4,370 IU per day (high dose) for one year. FLS were assessed monthly by telephonic interviews. Serum levels of 25-hydroxy-D (25-OH-D), calcium, PTH, IL-17, IL-10 and IFN-γ were measured periodically. EDSS, relapses, adverse events and quality of life (QoL) were documented.Results25-OH-D levels increased to a significantly higher levels and PTH levels decreased in the high dose group. There was no significant change in FLS. IL-17 levels were significantly increased in the low dose group, while patients receiving high dose vitamin D had a heterogeneous IL-17 response. No significant differences in relapse rate, EDSS, QoL, serum IL-10 and IFNγ were found. Hypercalcemia or other potential major adverse events were not observed.ConclusionVitamin D supplementation to IFN−β treated PwMS, at the doses used, seems safe and associated with dose-dependent changes in IL-17 serum levels, while not affecting IFN−β related FLS.Trial registrationClinicalTrials.gov ID: NCT01005095
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