Evaluating adherence, tolerability and safety of oral calcium citrate in elderly osteopenic subjects: a real-life non-interventional, prospective, multicenter study.

BACKGROUND: Osteoporosis is a common concern in the elderly that leads to fragile bones. Calcium supplementation plays a crucial role in improving bone health, reducing fracture risk, and supporting overall skeletal strength in this vulnerable population. However, there is conflicting evidence on the safety of calcium supplements in elderly individuals. AIM: The aim of this study was to evaluate the adherence, safety and tolerability of calcium citrate supplementation in elderly osteopenic subjects. METHODS: In this non-interventional, prospective, multicenter study, subjects received daily 500 mg calcium citrate supplementation for up to one year. Adherence was calculated based on compliance and persistence. Safety was assessed through adverse reactions (ARs), deaths, and clinical laboratory evaluations. RESULTS: A total of 268 Caucasian subjects (91.4% female, mean age 70 ± 4.5 years) participated in the study. Mean adherence to treatment was 76.6 ± 29.5% and half of subjects had an adherence of 91% and ~ 33% of participants achieved complete (100%) adherence. ARs were reported by nine (3.9%) subjects, primarily gastrointestinal disorders, with no serious ARs. The frequency of all adverse events (including ARs) was significantly higher in subjects with adherence of < 80% (41.6%; 32/77) vs. those with adherence ≥ 80% (11%; 16/145, p < 0.0001). Both systolic and diastolic blood pressure decreased from baseline to follow-up visit (change of -2.8 ± 13.9 mmHg, p = 0.0102 and -2.1 ± 10.4 mmHg, p = 0.0116, respectively). CONCLUSION: This study demonstrated favorable adherence to calcium citrate supplementation in elderly osteopenic subjects. The occurrence of ARs, though generally mild, were associated with lower adherence to calcium supplementation.

Image-guided thermal ablation in autonomously functioning thyroid nodules. A retrospective multicenter three-year follow-up study from the Italian Minimally Invasive Treatment of the Thyroid (MITT) Group.

OBJECTIVES: To report the results of a multicenter retrospective evaluation of the clinical outcomes of thermal ablation (TA) in a large series of autonomously functioning thyroid nodules (AFTN) with a follow-up protracted up to 3 years. METHODS: Patients treated with single TA for an AFTN in Italy were included. Changes in nodule volume, TSH values, and ongoing anti-thyroid therapy were assessed at the 2-, 6-, 12-, 24-, and 36-month follow-up controls. Complications and need of any additional therapy after TA were also registered. RESULTS: A total of 361 patients (244 females, 117 males, median age 58 years, IQR 46-70 years) were included. Nodule volume was significantly reduced at all time points (p < 0.001) (median volume reduction 58% at 6-month and 60% at 12-month). Serum TSH values increased significantly at all time points. After TA, anti-thyroid therapy was withdrawn in 32.5% of patients at 2 months, in 38.9% at 6 months, and in 41.3% at 12 months. A significant difference in the rate of patients who withdrawn medical therapy at 12 months was registered between small (< 10 mL) (74%), medium (49%), or large (> 30 mL) nodules (19%). A single major complication occurred (0.25%). Additional treatments were needed in 34/361 (9.4%) of cases including 4 (1.1%) surgical treatment. CONCLUSIONS: Image-guided thermal ablation offers a further safe and effective therapeutic option in patients with AFTN. Clinical outcomes are significantly more favorable in small than in large size AFTN. KEY POINTS: • Thermal ablations (TA) can be safely and effectively used in patients with autonomously functioning thyroid nodules (AFTN). • TA results in a clinically significant nodule volume reduction that is paralleled by TSH level normalization and anti-thyroid drug therapy discontinuation (after TA anti-thyroid therapy was withdrawn in 41.3% at 12 months). • Clinical outcomes after TA are more favorable in small nodules, and when a large amount of thyroid nodule tissue is ablated.

Inositols: From Established Knowledge to Novel Approaches.

Myo-inositol (myo-Ins) and D-chiro-inositol (D-chiro-Ins) are natural compounds involved in many biological pathways. Since the discovery of their involvement in endocrine signal transduction, myo-Ins and D-chiro-Ins supplementation has contributed to clinical approaches in ameliorating many gynecological and endocrinological diseases. Currently both myo-Ins and D-chiro-Ins are well-tolerated, effective alternative candidates to the classical insulin sensitizers, and are useful treatments in preventing and treating metabolic and reproductive disorders such as polycystic ovary syndrome (PCOS), gestational diabetes mellitus (GDM), and male fertility disturbances, like sperm abnormalities. Moreover, besides metabolic activity, myo-Ins and D-chiro-Ins deeply influence steroidogenesis, regulating the pools of androgens and estrogens, likely in opposite ways. Given the complexity of inositol-related mechanisms of action, many of their beneficial effects are still under scrutiny. Therefore, continuing research aims to discover new emerging roles and mechanisms that can allow clinicians to tailor inositol therapy and to use it in other medical areas, hitherto unexplored. The present paper outlines the established evidence on inositols and updates on recent research, namely concerning D-chiro-Ins involvement into steroidogenesis. In particular, D-chiro-Ins mediates insulin-induced testosterone biosynthesis from ovarian thecal cells and directly affects synthesis of estrogens by modulating the expression of the aromatase enzyme. Ovaries, as well as other organs and tissues, are characterized by a specific ratio of myo-Ins to D-chiro-Ins, which ensures their healthy state and proper functionality. Altered inositol ratios may account for pathological conditions, causing an imbalance in sex hormones. Such situations usually occur in association with medical conditions, such as PCOS, or as a consequence of some pharmacological treatments. Based on the physiological role of inositols and the pathological implications of altered myo-Ins to D-chiro-Ins ratios, inositol therapy may be designed with two different aims: (1) restoring the inositol physiological ratio; (2) altering the ratio in a controlled way to achieve specific effects.

Iodine and Myo-Inositol: A Novel Promising Combination for Iodine Deficiency.

Despite universal salt iodization programmes implemented over the last decades, iodine deficiency remains a major public health problem in many countries worldwide. Endeavors are still required to ensure sufficient iodine intake in the populations at risk in order to eliminate deficiency. Iodine is crucial for the synthesis of thyroid hormones triiodothyronine (T3) and thyroxine (T4), as well as for the thyroid health. When iodine levels are insufficient, T4 attests toward the lower limit of the physiological range, causing subtle fluctuations in the T3:T4 ratio. Monitoring these variations may be an accurate way to assess patient's iodine status. Recently, a number of published clinical studies documented a growing interest toward the use of myo-inositol in thyroid diseases. Myo-inositol, a carbocyclic polyol, regulates the generation of hydrogen peroxide (H2O2) in thyrocytes, crucial for iodine organification and thyroid hormone biosynthesis. Thus, combined supplementation of iodine and myo-inositol may promote higher iodine availability in thyrocytes improving thyroid functionality. This review presents novel strategies for the diagnosis and the management of iodine deficiency, focusing on the potential role of myo-inositol combined with iodine.

Recombinant human thyroid-stimulating hormone is effective for radioiodine ablation of post-surgical thyroid remnants.

OBJECTIVE: To investigate whether recombinant human thyroid-stimulating factor (rhTSH) is effective for the radiometabolic ablation of post-surgery thyroid remnants, using low doses of (131)I. PATIENTS AND METHODS: The study included two groups of patients enrolled consecutively: group 1 consisted of 52 patients with papillary cancer or minimally invasive follicular cancer (stage I and II), and group 2 consisted of 41 patients with the same stage of disease. All patients underwent a total thyroidectomy. Group 1 received 1.11 GBq (30 mCi) (131)I for post-surgical remnants ablation with the aid of rhTSH, while group 2, in the hypothyroid state, received the same amount of radioiodine. To minimize iodine interference, all patients remained on a low iodine diet for 2 weeks and L-thyroxine (L-T4) was stopped for 4 days in the group of patients treated with the aid of rhTSH. To investigate (131)I uptake in this group, a tracer dose was administered 3 h after the second injection of rhTSH and the uptake was evaluated at 24 h just before administration of the therapeutic dose. I was also measured in the patients treated in the hypothyroid state just before the therapeutic dose was given. RESULTS: After 1 year both groups were studied by using whole-body scintigraphy (WBS) and measuring thyroglobulin after rhTSH. In group 1, WBS was negative in 76.9% (40 patients), while thyroglobulin-stimulated levels were <1.0 ng . ml(-1) in 86.5% (45 patients). In Group 2, WBS was negative in 75.6% (31 patients), while thyroglobulin-stimulated levels were <1 ng . ml(-1) in 78.0% (32 patients). (131)I uptake was 2.29+/-0.45 in the group treated with the aid of rhTSH, and 3.30+/-0.7 in the group treated in the hypothyroid state (P=0.2). No patients treated with the aid of rhTSH and with the short stoppage of L-T4 experienced symptoms of hypothyroidism, and free thyroxine (FT4) and thyroid-stimulating hormone levels remained normal. CONCLUSIONS: Our data confirm that, when the interference of iodine is minimized, rhTSH is highly effective for the treatment of post-surgical thyroid remnants using a low dose of (131)I.