Efficacy and Safety of Weekly Calcifediol Formulations (75 and 100 µg) in Subjects with Vitamin D Deficiency: A Phase II/III Randomised Trial.

Background/objective: Optimal vitamin D levels are required for bone health and proper functionality of the nervous, musculoskeletal and immune systems. The objective of this study was to assess the efficacy and safety profiles of new weekly calcifediol formulations with the potential to improve adherence and outcome.

Methods: A Phase II-III, double-blind, randomized, multicentre trial (EudraCT 2020-001099-14 and NCT04735926).

Use of Tirzepatide in Adults with Type 2 Diabetes Mellitus: Scientific Evidence and Practical Aspects.

Tirzepatide is a novel antidiabetic medication a single-molecule, agonist to the glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptors. It is approved in the USA and EU for the treatment of type 2 diabetes mellitus (T2DM) and obesity. Due to the potential novelty represented by incorporating tirzepatide to clinical practice, we aim to review practical aspects of tirzepatide use in T2DM and the supporting scientific evidence.

Comprehensive approach to people with type 2 diabetes. Diabetes Knowledge Area of the Spanish Society of Endocrinology and Nutrition.

Objective: To provide practical recommendations for the comprehensive approach of people with type 2 diabetes according to evidence-based medicine.

Participants: Members of the Diabetes Knowledge Area of the Spanish Society of Endocrinology and Nutrition.

Methods: The recommendations were formulated according to the degrees of evidence of the Standards of Medical Care in Diabetes-2022.

Psychometric properties of the Clarke questionnaire for hypoglycemia awareness in the Spanish population with type 2 diabetes.

Objectives: The Clarke questionnaire, validated in Spanish language, assesses hypoglycemia awareness in patients with type 1 diabetes. This study aimed to analyze its psychometric properties in patients with type 2 diabetes (T2DM).

Methods: This was a questionnaire validation study.

Romosozumab efficacy and safety in European patients enrolled in the FRAME trial.

Unlabelled: In this post hoc analysis, we assessed romosozumab efficacy and safety in European patients enrolled in FRAME. Romosozumab treatment through 12 months, followed by denosumab for a further 24 months, resulted in early and sustained risk reduction for major fracture categories, associated with large gains in bone mineral density.

Introduction: In the multinational FRAME phase 3 trial of romosozumab in postmenopausal women with osteoporosis, marked differences between clinical and non-vertebral fracture outcomes were observed among patients from Central and Southern America versus rest of world.

Guide of management of alterations in mineral and bone metabolism during gestation and lactation.

Objective: To provide practical recommendations for the management of mineral and bone metabolism alterations in pregnancy and lactation.

Participants: Members of the Working Group on Osteoporosis and Mineral Metabolism of the Spanish Society of Endocrinology and Nutrition.

Methods: Recommendations were formulated according to the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system to describe both the strength of recommendations and the quality of evidence.

Executive summary: Position document: Evaluation and management of hypoglycemia in the patient with diabetes mellitus 2020. Diabetes Mellitus Working Group of the Spanish Society of Endocrinology and Nutrition.

Objective: To provide practical recommendations for the evaluation and management of hypoglycemia in patients with diabetes mellitus.

Participants: Members of the Diabetes Mellitus Working Group of the Spanish Society of Endocrinology and Nutrition (SEEN).

Methods: The recommendations were made based on the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) system to establish both the strength of the recommendations and the level of evidence.

Executive summary: Position document: Evaluation and management of hypoglycemia in the patient with diabetes mellitus 2020. Diabetes Mellitus Working Group of the Spanish Society of Endocrinology and Nutrition.

Objective: To provide practical recommendations for the evaluation and management of hypoglycemia in patients with diabetes mellitus.

Participants: Members of the Diabetes Mellitus Working Group of the Spanish Society of Endocrinology and Nutrition (SEEN).

Methods: The recommendations were made based on the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) system to establish both the strength of the recommendations and the level of evidence.

New technologies in the evaluation of bone fragility and its application in Endocrinology.

Bone mineral density using dual-energy X-ray absorptiometry is the gold standard for the assessment of bone and an important predictor of fracture risk. However, most fragility fractures occur in people without densitometric osteoporosis, especially in endocrinological diseases. Fracture risk estimation tools such as FRAX have improved diagnostic sensitivity but do not include additional skeletal features.

Estimation of Long-Term Efficacy of Denosumab Treatment in Postmenopausal Women With Osteoporosis: A FRAX- and Virtual Twin-Based Post Hoc Analysis From the FREEDOM and FREEDOM Extension Trials.

The 3-year placebo-controlled FREEDOM (Fracture REduction Evaluation of Denosumab in Osteoporosis Every 6 Months) trial established the antifracture efficacy of denosumab in postmenopausal women with osteoporosis. The 7-year open-label extension demonstrated that denosumab treatment for up to 10 years was associated with low rates of adverse events and low fracture incidence. The extension lacked a long-term control group, thus limiting the ability to fully evaluate long-term efficacy.

Phosphate disorders and clinical management of hypophosphatemia and hyperphosphatemia.

Serum phosphorus levels range from 2.5 and 4.5mg/dL (0.

Is vitamin-D supplementation not useful in patients at risk of fractures and falls?

To evaluate numerous publications that question the bone and extraosseous benefits of vitamin D diet supplementation based on results, which often transcend to public opinion, but are not well interpreted. This may have negative consequences on compliance of patients under vitamin D supplementation. Critical appraisal of several articles on vitamin D supplementation and its relationship with fractures, falls, cardiovascular diseases, and cancer incidence.

Reductions in Insulin Resistance are Mediated Primarily via Weight Loss in Subjects With Type 2 Diabetes on Semaglutide.

Context: Semaglutide, a once-weekly glucagon-like peptide-1 analog approved for use in patients with type 2 diabetes (T2D), demonstrated superior body weight (BW) reductions and decreased insulin resistance (IR) vs comparators across the Semaglutide Unabated Sustainability in Treatment of Type 2 Diabetes (SUSTAIN) 1-3 clinical trials.

Objective: To investigate the relationship between IR and BW across the SUSTAIN 1-3 trials.

Design: Post hoc analysis of the SUSTAIN 1-3 trials.

Document on a comprehensive approach to type 2 diabetes mellitus.

Objective: Treatment of type 2 diabetes mellitus (T2DM) is complex and is intended to decrease morbidity and mortality. Management should therefore include adequate diabetes education, lifestyle changes, drug treatment to achieve early blood glucose control and reduction of cardiovascular (CV) risk factors, early detection and treatment of complications, and assessment of associated comorbidities. The objective was to prepare a document including all aspects required for a comprehensive approach to T2DM.

Romosozumab (sclerostin monoclonal antibody) versus teriparatide in postmenopausal women with osteoporosis transitioning from oral bisphosphonate therapy: a randomised, open-label, phase 3 trial.

Background: Previous bisphosphonate treatment attenuates the bone-forming effect of teriparatide. We compared the effects of 12 months of romosozumab (AMG 785), a sclerostin monoclonal antibody, versus teriparatide on bone mineral density (BMD) in women with postmenopausal osteoporosis transitioning from bisphosphonate therapy.

Methods: This randomised, phase 3, open-label, active-controlled study was done at 46 sites in North America, Latin America, and Europe.

Recommended vitamin D levels in the general population.

Objective: To provide recommendations based on evidence on the management of vitaminD deficiency in the general population.

Participants: Members of the Bone Metabolism Working Group of the Spanish Society of Endocrinology.

Methods: Recommendations were formulated using the GRADE system (Grading of Recommendations, Assessment, Development, and Evaluation) to describe both the strength of recommendations and the quality of evidence.

Recommendations on the effect of antidiabetic drugs in bone.

Objective: To provide recommendations on the effect of antidiabetic drugs on bone fragility to help select the most adequate antidiabetic treatment, especially in diabetic patients with high risk of fracture.

Participants: Members of the Bone Metabolism Working Group of the Spanish Society of Endocrinology.

Methods: The GRADE system (Grading of Recommendations, Assessment, Development, and Evaluation) was used to establish both the strength of recommendations and the quality of evidence.

[Update of recommendations for evaluation and treatment of osteoporosis associated to endocrine and nutritional conditions. Working Group on Osteoporosis and Mineral Metabolism of the Spanish Society of Endocrinology].

Objective: To update previous recommendations developed by the Working Group on Osteoporosis and Mineral Metabolism of the Spanish Society of Endocrinology and Nutrition for the evaluation and treatment of osteoporosis associated to different endocrine and nutritional diseases.

Participants: Members of the Working Group on Osteoporosis and Mineral Metabolism of the Spanish Society of Endocrinology and Nutrition.

Methods: Recommendations were formulated according to the GRADE system (Grading of Recommendations, Assessment, Development, and Evaluation) to describe both the strength of recommendations and the quality of evidence.

Prevalence of osteoporosis, vertebral fractures and hypovitaminosis D in postmenopausal women living in a rural environment.

Objectives: First, to study the difference between two groups of postmenopausal women living in different population centres (rural vs urban) in the prevalence of osteoporosis, fragility fractures and factors which may influence them: hypovitaminosis D, bone mineral density, coexistence of other diseases which predispose to their appearance; secondly, to observe the influence of low socioeconomic status, categorised as poverty.

Study Design: 1229 postmenopausal women were studied, of whom 390 (31.7%), were living in rural areas and 839 (68.

[Consensus statement: recommendations for the management of metabolic bone disease in human immunodeficiency virus patients].

Objective: To provide practical recommendations for the evaluation and treatment of metabolic bone disease in human immunodeficiency virus (HIV) patients.

Participants: Members of scientific societies related to bone metabolism and HIV: Grupo de Estudio de Sida (GeSIDA), Sociedad Española de Endocrinología y Nutrición (SEEN), Sociedad Española de Investigación Ósea y del Metabolismo Mineral (SEIOMM), and Sociedad Española de Fractura Osteoporótica (SEFRAOS).

Methods: A systematic search was carried out in PubMed, and papers in English and Spanish with a publication date before 28 May 2013 were included.

Position statement: hypoglycemia management in patients with diabetes mellitus. Diabetes Mellitus Working Group of the Spanish Society of Endocrinology and Nutrition.

Objective: To provide practical recommendations for evaluation and management of hypoglycemia in patients with diabetes mellitus.

Participants: Members of the Diabetes Mellitus Working Group of the Spanish Society of Endocrinology and Nutrition.

Methods: Recommendations were formulated according to the Grading of Recommendations, Assessment, Development, and Evaluation system to describe both the strength of recommendations and the quality of evidence.

[Normocalcemic primary hyperparathyroidism: recommendations for management and follow-up].

Objective: To provide practical recommendations for evaluation and follow-up of patients with normocalcemic primary hyperparathyroidism.

Participants: Members of the Bone Metabolism Working Group of the Spanish Society of Endocrinology.

Methods: A systematic search was made in MEDLINE (PubMed), using the terms normocalcemic primary hyperparathyroidism and primary hyperparathyroidism, for articles in English published before 22 November 2012.

Identifying and managing patients at high risk for fractures: conclusions from the second Spanish multidisciplinary forum-parathyroid hormone use in osteoporotic patients at high risk for fractures.

Purpose: The Second Multidisciplinary Forum: Parathyroid Hormone (PTH) Use in Osteoporotic Patients at High Risk for Fractures (HRF) was conducted to identify specific findings that would be helpful for defining high-risk status and guiding the use of parathyroid hormone 1-84 (PTH1-84) as an anabolic therapy in daily clinical practice. This article summarizes the conclusions from the meeting.

Materials And Methods: Based on three typical case records, and the final conclusions from the first Forum (held in 2010), several questions were posed regarding daily clinical practice definitions of HRF and use of PTH1-84, through a series of 19 meetings throughout Spain.