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Bone Disease clinical trials

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NCT ID: NCT05642143 Recruiting - Type 2 Diabetes Clinical Trials

Deep Phenotyping of Bone Disease in Type 2 Diabetes and Relations to Diabetic Neuropathy

Start date: February 24, 2023
Phase:
Study type: Observational

Objectives: The goal of this cross sectional clinical trial is to examine the phenotype of bone disease in type 2 diabetes.The main aims are to: 1. Compare bone microarchitecture, bone biomechanical competence, and bone turnover markers as well as postural control in T2D patients with and without fractures. 2. Examine how autonomic and peripheral neuropathy affects bone microarchitecture, bone material strength and bone turnover markers as well as postural control in T2D. Methods: The trial is of cross-sectional design and consists of examinations including - Blood samples to analyze bone markers, glycemic state i.e. - Bone scans including dual energy x-ray absorptiometry (DXA) and high resolution peripheral quantitative computed tomography (HRpQCT) to evaluate Bone Mineral Density, t-score and bone structure. - Microindentation to evaluate bone material strength - Skin autofluorescence to measure levels of advanced glycation endproducts (AGEs) in the skin - Assesment of nerve function (peripheral and autonomic) - Assesment of postural control, muscle strength and gait Participants: A total of 300 type 2 diabetes patients divided to three groups: - 160 with no history of fractures or diabetic neuropathy - 100 with a history of fracture(s) - 40 with autonomic neuropathy or severe peripheral neuropathy

NCT ID: NCT02976246 Completed - Clinical trials for Cardiovascular Disease

Effect of Vitamin K2 (MK7) on Cardiovascular and Bone Disease in Dialysis Patients

RenaKvit
Start date: November 2016
Phase: Phase 4
Study type: Interventional

Cardiovascular disease (CVD) is the most frequent cause of death in patients (ptt.) with chronic kidney disease (CKD). Compared to the general population death due to CVD is 10-20 times higher in CKD ptt. being treated with hemodialysis. Vascular calcification and hence arterial stiffness is of great importance for the high incidence of CVD. CKD ptt. in dialysis treatment also have a 3 times higher risk of bone fractures. Both vertebral and other fractures of low energy are associated with a high mortality. Matrix Gla Protein (MGP) is an important inhibitor of vascular calcification and Osteocalcin (OC) is an important regulator of bone metabolism. The function of both MGP and OC depend on vitamin K. Vitamin K is supplied with food. The content is low in food recommended to CKD ptt. which is reflected in very low concentrations of vitamin K in their blood samples. A correlation between vitamin K level, incidence of vascular calcification and bone density has been proven; yet there are no trials elucidating the clinical effect of vitamin K on vascular calcification or bone strength. The investigators will conduct a randomized placebo controlled trial examining the clinical effects of vitamin K2 on vascular calcification and bone mineralization in order to prevent and treat CVD and bone disease in CKD ptt. Primary study endpoints: 1. Changes in arterial stiffness assessed by pulse wave examination 2. Changes in bone mineral density (BMD) in distal radius assessed by DXA-scans. Secondary study endpoints: Changes in coronary artery and valvular calcification assessed by heart-CT-scans, blood pressure, body composition, total and regional BMD, lateral column/aortic calcification score as well as a panel of correlating blood tests.

NCT ID: NCT02575352 Recruiting - Bone Disease Clinical Trials

Calcium Phosphate Cement Registry (CPC Registry)

CPC
Start date: May 2015
Phase:
Study type: Observational [Patient Registry]

CPC REGISTRY is a multi-center, international, prospective, open-label, observational study on the use of injectable calcium phosphate cements for the treatment of bone defects in adults. All patients will be treated with any of the two injectable calcium phosphate bone substitutes (GRAFTYS®HBS/GRAFTYS®Quickset or their private labels) according to standard clinical practice and according to the information provided by GRAFTYS manufacturer in respective device Instructions For Use (IFU).

NCT ID: NCT02558452 Not yet recruiting - Quality of Life Clinical Trials

European Transplant Registry of Senior Renal Transplant Recipients on Advagraf

SENIOR
Start date: December 2016
Phase: N/A
Study type: Observational [Patient Registry]

SENIOR transplant Registry European transplant registry of senior renal transplant recipients (above the age of 65 years) receiving initial immunosuppression with tacrolimus once daily, mycophenolate and steroids to investigate long term outcomes on an observational basis.

NCT ID: NCT02539498 Completed - Clinical trials for Primary Hyperparathyroidism

Bone Architectural Parameters in Postmenopausal Women Affected With Primary Hyperparathyroidism

MicrOs
Start date: April 2012
Phase: N/A
Study type: Interventional

Bone lesions are frequent in primary hyperparathyroidism (PHPT). Conventional measurement by Dual-Energy X-ray Absorptiometry does not provide enough information about the bone impact of excessive parathyroid hormone (PTH) secretion. High-Resolution peripheral Quantitative Computed Tomography (HR-pQCT) assesses separately cortical and trabecular bone sites as well as geometric characteristics of peripheral skeleton. In postmenopausal women, HR-pQCT has shown that decreased microarchitectural parameters are associated with reduced bone strength independently of BMD. The purpose of this study is to characterize the impact of PHPT in cortical and trabecular bone measured by HR-pQCT in postmenopausal women with PHPT followed for one year, in comparison with control postmenopausal women.

NCT ID: NCT02359214 Completed - Diabetes Clinical Trials

Effect of Vitamin D3 Supplementation on Cardiometabolic Risk

Start date: April 2014
Phase: N/A
Study type: Interventional

Supplementation studies with vitamin D have been performed where cardiometabolic risk markers have been assessed but these are few, and results are inconsistent. Hence, the purpose of this study is to determine: 1. Whether administering supplemental Vitamin D3 at a dose of 5000IU/day (125µg) in overweight and obese adult participants for 8 weeks will significantly increase circulating concentrations of 25(OH)D or achieve optimal vitamin D status. 2. Whether administering supplemental Vitamin D3 at a dose of 5000IU/day (125µg) in overweight and obese participants for 8 weeks will significantly improve the cardiometabolic parameters measured. 3. To evaluate the relationship between these variables and 25(OH)D concentration. We hypothesise that there will be a significant increase in plasma 25(OH)D following 8 weeks (56days) supplementation of oral vitamin D3 at a dose of 5000IU/day (125µg); Administering supplemental Vitamin D3 at a dose of 5000IU/day (125µg) in overweight and obese participants for 8 weeks will significantly improve the cardio metabolic parameters measured, and there will be a relationship between these variables and 25(OH)D concentrations.

NCT ID: NCT02306694 Completed - Hemophilia Clinical Trials

Prospective Biomarkers of Bone Metabolism in Hemophilia A

Start date: December 2014
Phase: Phase 3
Study type: Interventional

One of the major shortcomings in studying bone disease in hemophilia is the lack of fracture outcome data demonstrating the clinical significance of decreased BMD and altered bone biomarkers in the hemophilia population. This study demonstrates that PwH have an increased risk of fracture compared to the general population and that the issue of bone health will increase in importance as the PwH population ages.

NCT ID: NCT02235493 Completed - Hypophosphatasia Clinical Trials

Non-interventional Substudy of ALX-HPP-502 to Assess Natural History of Patients With Juvenile-onset HPP Who Served as Historical Controls in ENB-006-09

Start date: August 2014
Phase:
Study type: Observational

The purpose of this study is to characterize the natural history of HPP in patients with Juvenile-onset HPP who served as historical controls in ENB-006-09.

NCT ID: NCT02011620 Withdrawn - Clinical trials for Endothelial Dysfunction

Influence of Nitrates on Bone Remodeling and Endothelial Function in Patients With Type 2 Diabetes Mellitus

Start date: October 2014
Phase: Phase 4
Study type: Interventional

Type 2 diabetes mellitus (DM) is becoming a leading global epidemic. DM affects several systems in the body. Most of the complications encountered in DM are attributed to uncontrolled hyperglycemia or poor glycemic control. Hyperglycemic stress tends to damage the inner lining of the small blood vessels (endothelium). Normally, the endothelium releases a chemical substance called nitric oxide (NO) which relaxes the blood vessels and also prevents blockade of these vessels. Therefore damage to the endothelium (endothelial dysfunction) results in diminished levels of NO which ultimately leads to occlusion of these small blood vessels (microvascular occlusion). Microvascular occlusion of vessels supplying the eyes, kidneys and nerves leads to serious complications like diabetic retinopathy, nephropathy and neuropathy. Of late, the skeletal system has emerged as another vulnerable target of diabetic microvascular disease. Patients with DM have an increased risk of developing fractures. Certain predisposing factors like diabetic neuropathy and visual disturbances (retinopathy and cataract) increases the likelihood of fractures in DM. More recently, evolving research has demonstrated NO's prospective role in bone preservation. Earlier studies have also validated the use of nitrates (donor of NO) in improving bone strength and reducing the risk of fractures. So far no study has investigated the effect of nitrates on endothelial function and bone microarchitecture in patients with diabetes. The investigators therefore propose to investigate the influence of nitrates on endothelial dysfunction and bone integrity in patients with type 2 diabetes. 40 patients with type 2 DM will be recruited into the study; 20 patients will receive 20 mg of oral isosorbide mononitrate daily and the other 20 will not receive the study drug. The investigators hope to demonstrate an improvement in endothelial function (by measuring skin blood flow) and bone integrity (by measuring markers of bone formation and bone resorption and bone mineral density - BMD) following 6 months of nitrate therapy.

NCT ID: NCT01740115 Completed - HIV Infection Clinical Trials

Boston Alcohol Research Collaboration on HIV/AIDS (ARCH) Cohort

Start date: November 2012
Phase: N/A
Study type: Observational

The purpose of this study is to expand and continue a cohort of HIV-infected adults to establish the longitudinal Boston ARCH Cohort of 250 HIV-infected men and women with current substance dependence or ever injection drug use that have a spectrum of alcohol use; and to determine the effect of alcohol consumption on changes in bone health prospectively in the Cohort.