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Bone Disease clinical trials

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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: 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: 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.

NCT ID: NCT01476501 Completed - Clinical trials for Diabetic Nephropathy

Vitamin D Supplementation in Diabetic Nephropathy

Start date: October 2011
Phase: Phase 2
Study type: Interventional

Diabetes is a life-long disease that is getting more common in Canada. One of the most common problems in people with kidney disease is diabetes and low bone mineral density (BMD). This can lead to a higher chance for broken bones, infection and life-long health problems. The most common reason for having low BMD is not getting enough vitamin D (Vit D) in your diet and not having enough sunlight. This is very common in Canada (especially in northern Alberta) because winter is very long. Most people also don't eat or drink enough foods that are high in Vit D (like milk) and so they don't have enough Vit D in their body to make healthy bones. This can mean the only way to get enough Vit D in your body for your bones when you have kidney disease is to take some extra vitamin D in a pill. Most people are not aware that they have poor bone health until they break a bone. Broken bones can really hurt and can prevent a person from being able to walk and take care of themselves. Right now, we are not sure exactly how much Vit D people with diabetes and kidney disease need to take to prevent them from having low BMD or how often they need to take it. Our plan is to study the effect of two ways to take Vit D pills (every day or once a month) on overall Vit D status and on bone health in adult patients with diabetes and chronic kidney disease and see how this influences their quality of life. Hypotheses: 1. Vitamin D supplementation (2,000 IU/day and 40,000 IU/month) for six months will result in significantly improved overall vitamin D status and improved markers of bone health in adult patients with diabetic nephropathy. 2. Monthly dosing of vitamin D (40,000 IU/month) over six months will result in improved patient adherence and satisfaction with vitamin D supplementation when compared to daily dosing of vitamin D (2000 IU/D). This will improve vitamin D status and bone health parameters, which will result in an increased quality of life and sense of well-being.

NCT ID: NCT01293487 Completed - Osteoporosis Clinical Trials

Safety And Tolerability Study Of RN564 In Women With Osteopenia And Healthy Men.

Start date: April 2011
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the safety and tolerability of RN564 in women with osteopenia and healthy men.

NCT ID: NCT00913796 Completed - Metabolic Acidosis Clinical Trials

Metabolic Acidosis in Renal Transplant Patients

MART
Start date: December 2007
Phase: Phase 2
Study type: Interventional

Acidosis (accumulation of acid in the body) may be an underrecognized problem in patients after renal transplantation. It may have consequences on physical performance due to negative effects on bone and muscle metabolism. Therefore, the purpose of this study is 1. to determine the status of physical capacity and bone structure in renal transplant patients with metabolic acidosis 2. to study the effect of substituting base equivalents (citrate) on acid/base status of renal transplant patients with acidosis 3. to compare the status of physical capacity and bone structure in renal transplant patients with metabolic acidosis before and after substitution with citrate

NCT ID: NCT00001391 Completed - Healthy Clinical Trials

Bone Regeneration Using Bone Marrow Stromal Cells

Start date: August 3, 1994
Phase: N/A
Study type: Observational

Deficient or inappropriate healing of bone impacts clinical decision-making and treatment options in orthopedics, oral and maxillofacial surgery, plastic surgery and periodontics. While a number of auto- and allografting techniques have been used to regenerate craniofacial defects caused by infective, neoplastic or trauma-induced bone loss, each method has significant limitations. Our research group in the Craniofacial and Skeletal Diseases Branch of NIDCR has developed methods to culture and expand cell populations derived from mouse bone marrow stroma. We believe that an important next step is to apply the information gained in animal studies to treat osseous defects in humans. We propose to examine the potential of cultured human bone marrow stromal cells to serve as an abundant source of osteoblastic progenitor cells. These cells will ultimately be used to graft craniofacial osseous defects. In the course of this study we will: (1) develop methods for the propagation and enrichment of osteoblastic progenitor cells from bone marrow stroma; (2) test various vehicles for the transfer of bone marrow stromal cells to osseous defects in recipient animals; (3) determine optimal culturing and transplantation conditions for the eventual transplantation of bone marrow stromal cells into human recipients. These studies will define the parameters of bone marrow stromal cell transplantation and will generate models for future therapeutic strategies.