Efficacy of Zoledronic Acid to Prevent Bone Loss Following Denosumab Discontinuation
OsteoporosisOsteoporosis3 moreThis two-year observational, open-label clinical trial will evaluate the efficacy of a once-yearly infusion of zoledronic acid after denosumab discontinuation to maintain tissue mineral density and bone microarchitecture using high-resolution peripheral quantitative computed tomography (HR-pQCT) among post-menopausal women with osteoporosis.
Effectiveness and Safety of EuBone® Capsules for Bone Health in Postmenopausal Women
OsteoporosisPostmenopausalEuBone is prepared by mixing eucommia ulmoides extract, fructus ulmoides extract and dodder extract in proportion. The aim of this study is to evaluate the effectiveness and safety of EuBone® capsules in slowing bone loss, preventing bone loss, and improving quality of life compared with placebo in Postmenopausal women.
Bone Health in Youth With Type 1 Diabetes
Type 1 DiabetesOsteoporosisThis is an observational study of children and young adults ages 6-20 years with type 1 diabetes and age- and race-matched controls. The investigators will be examining blood and urine hormone levels as well as measures of bone density including DXA and high-resolution peripheral quantitiative computed tomography. The investigators will also be collecting data regarding physical activity via use of wearable accelerometers. The investigators hypothesize that youth with type 1 diabetes will have slower bone accrual and impaired bone microarchitectural integrity compared with non-diabetic controls, and that bones of individuals with type 1 diabetes will not respond as well to physical activity. The investigators hypothesize that poor bone accrual will be associated with sub-optimal glucose control as well as lower levels of insulin-like growth factor 1.
Association Between DXA Results and the Complications, Clinical Courses and Outcomes in Chronic...
Chronic Kidney Disease Requiring Chronic DialysisOsteoporosisAims: To determine whether BMD and muscle mass were associated with fractures and other adverse events in dialysis patients. To explore the effects of the interactions among FGF23, calcium, phosphate, PTH and vitamin D on low bone mineral density and sacropenia in dialysis patients. Method: In this study, the investigators plan to use DXA to screen for BMD, relevant novel bone microstructure parameters, and body composition in chronic dialysis patients. Also, the investigators plan to use blood testing to measure the blood level of FGF23, calcium, phosphate, PTH and vitamin D. The investigators conduct a prospectively follow up program for these participants to evaluate clinical courses and outcomes. Patients will receive DXA (including BMD and body composition) tests and blood work at baseline and one-year. Muscle power and physical performance will be measured at baseline, 6 months and one-year.
Effervescent Calcium Magnesium Citrate to Prevent Mineral Metabolism and Renal Complications of...
OsteoporosisHypomagnesemiaProton pump inhibitors (PPIs) are widely used for the control of gastric ulcer-gastritis, erosive esophagitis (gastroesophageal reflux disease), peptic ulcer disease (duodenal ulcer), and heartburn. Despite their efficacy, their use has been implicated in possibly causing fragility fractures (osteoporosis), hypomagnesemia (magnesium deficiency) and increased risk of chronic kidney disease (CKD). The current trial represents the investigators ongoing effort to discern whether these complications could be averted by effervescent calcium magnesium citrate (EffCaMgCit).
Development of Cellular Models for Osteoblast Response Study to Adipocytic Secretions in an Osteoporosis...
OsteoporosisThe recent studies suggest that secretions from medullary adipocytes are involved in the mechanisms of bone loss in osteoporosis (OP) through their actions on neighbouring osteoforming cells, the osteoblasts. The objective of the research is the development of new cellular models representing the aging skeleton to confirm this hypothesis. To this end, osteoblasts will be isolated from human bone fragments coming from femoral heads discarded during total hip replacement surgery. The osteoblastic response to secreted factors released from medullary adipocytes of commercial origin will be analysed using conditioned media incubations. This phenotypic response will be quantified for each subject through the analysis of gene expression levels. Inter-subject phenotype variations will be related to bone density and microarchitecture data obtained by X-ray microtomography. This will assess the existence of a correlation between the osteoblast response to adipocyte secretions and the degree of osteoporosis of the subject from whom the cells are derived.
Clinical Pharmacokinetics and Pharmacodynamics Study of Different Doses of Zoledronic Acid
Postmenopausal OsteoporosisThe recommended dosing regimen of zoledronic acid in Chinese osteoporosis patients is completely in accordance with the one of 5 mg per year abroad that based on the dosing regimen in Paget's disease. This dosing regimen lacks the actual supportive clinical data of Chinese patients. In addition, the overall incidence of acute phase response, the main adverse event after the first infusion, in Chinese patients is higher than that in Caucasian patients population. Moreover, the results of the similar drug clinical study in the Japanese patients shown that the purpose of effective treatment for osteoporosis could be achieved with half of the dosage in Caucasian population. Thus, it could be inferred from these that the dosing regimen of zoledronic acid might be inappropriate in Chinese osteoporosis patients. Therefore, the main purpose of this clinical trail is to compare the zoledronic acid pharmacokinetic and pharmacodynamic characteristic of different doses in Chinese postmenopausal subjects with low bone mass or osteoporosis and explore the best dosing regimen in Chinese patients.
Effect of Acetylcholinesterase Inhibitors on Bone Metabolism
OsteoporosisPeople with Alzheimer's disease are at an increased risk of bone fracture. Some studies have shown that those taking donepezil have a lower rate of bone fractures, but the reasons for this are unknown. The purpose of this study is to measure the effect of donepezil treatment on bone metabolism factors including bone mineral density, bone turnover markers, and bone quality. Participants in this study will have a bone density test and have blood samples collected at the baseline study visit. Participants will then be randomly assigned to donepezil or matching placebo to be taken daily by mouth for 12 months. Blood samples will be collected at 6 and 12 months. A repeat bone density test will be performed at 12 months. Participants will also complete questionnaires at each study visit.
Evaluation of Romosozumab vs. Zoledronic Acid Effect in Patients With Spinal Cord Injury and Low...
Osteoporosis FractureSpinal Cord InjuriesThis is a randomized study to determine the effects of monthly romosozumab for one year or one-time zoledronic acid on bone mineral density (BMD) and biochemical markers of bone formation and resorption, in patients with spinal cord injury (SCI) and low BMD.
MR-based Characterization of Bone Marrow in Its Relevance to Skeletal Disease in Patients With Diabetes...
Diabetes MellitusType 22 moreFor a long time, no direct connection was seen between the two common diseases diabetes mellitus and osteoporosis. However, as more and more younger people are affected by obesity, develop type 2 diabetes mellitus and suffer osteoporotic fractures, the question of a connection between these clinical pictures has now arisen. Modern magnetic resonance imaging and spectroscopy techniques allow detailed and non-invasive characterization of bone marrow in different body regions. Low body weight (BMI<20kg/m²) has been shown to be associated with decreased bone density, while obesity has long been associated with high cortical bone mass - the idea of bone health. It has now been proven that obesity also has a negative effect on bone structure. Here, it is not only BMI that is crucial, but also the localization of fat tissue in the body. Visceral fat has a directly damaging effect on bone microarchitecture through dysregulated production and release of cytokines and adipokines. Thus, it has been shown that both type 1 and type 2 diabetic patients have a decreased rate of bone remodeling and very obese patients with type 2 diabetes have an increased risk of fracture. It must be concluded that body weight, or BMI, cannot be the sole measure for estimating bone health. Thus, type 2 diabetes shows reduced bone remodeling with normal or slightly increased bone density, but inferior stability. This means that type 2 diabetes is associated with an increased risk of osteoporotic fracture, even when bone density measurements are unremarkable. Loss of trabecular bone structure in red (hematopoietic) bone marrow is also characterized by increasing infiltration of the bone marrow space with fat cells (bone marrow adipose tissue). In contrast, the yellow bone marrow, which is mainly present in the diaphysis of tabular bones, has particularly large amounts of fat incorporated into the reticulum cells. For a long time, only the role of "placeholder" was attributed to these fat cells, but it has been shown that they interact with other cells via the production of autocrine, paracrine and endocrine hormones and cytokines, or adipokines, and are thus related to the metabolic state of the entire body. A basic assumption here is that the amount of unsaturated fatty acids in the adipose bone marrow is an important and functional marker for different types of adipocytes. It has been shown that 3 individuals with poorer insulin sensitivity have more unsaturated fatty acids in yellow bone marrow. Thus, the concept of different types of adipocytes in the bone marrow, with their inherent different fatty acid composition could serve to reconcile the at first glance counterintuitive physiological regulation of bone marrow fat and its response to metabolic perturbations. In order to show whether and how the composition of the yellow (unsaturated fatty acids) and red (bone marrow adipose tissue) bone marrow differs in healthy individuals, individuals with impaired insulin sensitivity in different age groups and patients with type 2 diabetes, and whether this can be used to detect early changes in the bone matrix with regard to bone density, the proportion of bone marrow adipose tissue in the red bone marrow at different locations in the skeleton will be quantified by means of chemical-shift-selective MRI sequences as well as the composition of bone marrow fat in the yellow bone marrow with regard to the proportions of monounsaturated and polyunsaturated fatty acids by means of volume-selective MRS. A total of 96 healthy volunteers (48 each male and female) aged 25 to 75 years and with body mass index between 18.5 and 35 kg/m² will be included. In addition, 24 patients (12female/12male) with type 2 diabetes will be recruited. After magnetic resonance examination, anthropometric and metabolic characterization (oral glucose tolerance test) will take place.