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A Phase 1 Randomized, Double-Blind, Placebo-Controlled Single and Multiple Ascending Dose Study of the Safety and Tolerability of Intravenous LLP2A-Alendronate in Adult Men and Women with Osteopenia Secondary to Corticosteroids.
The study is a genetic historical cohort study in a military combat recruits - this study does not examine a specific treatment but rather examines a statistical link between medical history of traumatic fractures, clinical diagnosis of stress fractures and the presence of unique SNPs in subjects DNA.
There has been no comparative data between oral ibandronate and oral ibandronate plus active vitamin D
There has been no comparative data between Zoledronic acid and Zoledronic acid combined with active vitamin D in primary and secondary osteoporosis.
Purpose: The Guangzhou Nutrition and Health Study (GNHS) aims to assess the determinants of risk of osteoporosis and cardio-metabolic diseases and changes in their relevant indices in nutritional aspects, as well as other environmental and genetic factors. Study design: GNHS is a community-based prospective cohort study. Participants: About 4540 apparently healthy residents, living in Guangzhou city (South China) for >5 years, aged 40-80 years, recruited between 2008 and 2013. Visits and Data Collection: Participants were/will be visited every three years by invited to the School of Public Health, Sun Yat-sen University. At each visit, face-to-face interviews, specimen collection, anthropometric measurements, DXA scanning, ultrasonography evaluation were/will be conducted. Up to May 2017, 3400 and 2380 subjects completed the 2nd and 3rd visits. Key variables: 1. Questionnaire interviews: Structured questionnaires were/will be used to collect the participants' socio-demographic characteristics, lifestyle factors, menstruation and reproductive history (women only), sleep quality, family history, psychological health, social support and participation, cognitive function, habitual dietary intake, use of supplements and history of chronic diseases. 2. Physical examinations: Anthropometric measurements, blood pressure tests, handgrip strength, and usual gait speed. 3. DXA scanning: A dual-energy x-ray absorptiometry (DXA) was/will be used to determine bone density and bone mineral content, bone geometry information, fat mass and muscle mass. 4. Ultrasonography evaluations: Ultrasonography evaluation was/will be performed to determine carotid artery intima-media thickness and plaque, and fatty liver. 5. Specimen collections: Overnight fasting blood sample and early morning first-void urine sample and faces samples were/will be collected, separated and stored at −80°C till tests. 6. Laboratory tests: 1. Blood tests: Metabolic syndrome-related indices; inflammatory markers; sexual hormones and SHBG; genetic markers; nutritional indices (e.g., carotenoids; fatty acids; minerals, folate, betaine, choline, and vitamin D, etc.) 2. Urinary tests: Flavonoids and flavones; minerals; creatinine and renal function related markers 3. Fecal test: Gut microbiota and related metabolites. 7. Morbidity and mortality: Relevant data were/will be also retrieved via local multiple health information systems.
Aims: To compare clinical outcomes for patients under FLS or usual care at the NTUH MH and BB. Method: Four hundred subjects with new hip fracture or newly identified vertebral fracture are randomly assigned into FLS and usual care (UC). FLS subjects received osteoporosis-related assessments, treatments, consultations on diet, medications, exercise, fall preventions given mainly by care managers with followed up telephone call at 4, 8, 12, 18, 24 months then annually for up to 10 years. Physicians manage UC subjects at their own plans without pre-specified protocols as FLS subjects. Care managers will perform baseline assessments and follow them by telephone annually for up to 10 years. Major outcomes include bone mineral density assessment rate, calcium, vitamin D, and osteoporosis medication initiation and adherence rate, fall and fracture incidences, mortality, and healthcare resource utilizations.
Autophagy is recognized as a central mechanism for the regulation of aging. . Osteoporosis (OA) and Alzheimer's disease (AD) are two forms of pathological aging, sometimes entangled, including an over-risk of OP in AD and degradation of cognitive functions after OP fracture, but the link between These two pathologies remain poorly understood. The aim of this prospective pilot study is to evaluate the level of autophagy of osteocytes (OST) in postmenopausal women with OP and to explore the hypothesis that the defect of autophagy is one of the physiopathological links of the OP During the MA
Osteoporosis has a devastating impact on quality of life of postmenopausal women, and is a significant cause of disability and morbidity. Many drugs are approved for the prevention and treatment of osteoporosis, but are associated with high costs and side effects. Some data from animal studies suggests that supplementation with probiotics can safely treat and prevent osteoporosis. The probiotic VSL#3 is commercially available, is safe for human consumption, and has been widely used in human clinical trials, and has known health-promoting effects in both children and adults. The double-blind, randomized, placebo-controlled trial of VSL#3 will be conducted for 12 months in 40 postmenopausal women to determine if VSL#3 improves bone mineral density and related bone markers. Study visits will include all or some of the following procedures: a medical exam, urine collection, height and weight measurement, a blood draw to assess bone biomarkers, a DEXA (dual energy X-ray absorptiometry) scan to measure bone density, and health questionnaires. This is one of the first clinical trials proposed to investigate the effects of probiotics in bone in humans. If successful, this proposal will provide the first evidence that nutritional supplementation with the probiotic VSL#3 is a safe and effective strategy for preventing postmenopausal bone loss.
To evaluate the effect of denosumab on lumbar spine bone mineral density (BMD) Z-score as assessed by dual-energy X-ray absorptiometry (DXA) at 12 months in children 5 to 17 year of age with Glucocorticoid (GC)-induced osteoporosis (GiOP).
Osteoporosis induced by glucocorticoids excess constitutes the main cause of secondary osteoporosis. Most of data available are provided from cohort studies of patients treated by corticosteroids, affecting among 1% of population. In contrast, very few data on osteoporosis are available in the Cushing syndrome (CS), a rare disease affecting 1 or 2 million of inhabitants, and characterized by an endogen glucocorticoid excess production. This affection is responsable of frequent fractures, occuring in 30-60% of patients (vertebral asymptomatic in 50% of case, hip, ribs). Fractures occurs often frequently above the threshold usually used for osteoporosis (T-score<-2.5), most often in the range of osteopenia. These data suggest that surface bone density isn't sufficient to characterize bone fragility, architectural factors are probably involved, and should be evaluated. The specificity of osteoporosis induced by endogen glucocorticoids excess in comparison with osteoporosis induced by estrogenic deficiency in post-menopausal women is poorly known, especially in endogen glucocorticoid excess. A recent microarchitecture studies showed alterations of cortical compartment in patients with Cushing's syndrome, confirming by our preliminary preclinical data from a transgenic murin model of Cushing's syndrome. In these ten last years, new radiologic tools have been developped, and are able to evaluate bone architecture. The peripheral Quantitative Computed analyses the bone architecture with distinction between cortical and trabecular compartment. Therefore, we aim to determine the specificity of osteoporosis induced by glucocorticoids excess in comparison to post menopausal osteoporosis thanks to pQCT analysis.