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Bone Diseases clinical trials

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NCT ID: NCT02843048 Active, not recruiting - Obesity Clinical Trials

Bariatric Surgery and Exercise Bone Trial

BaSEIB
Start date: April 2016
Phase: N/A
Study type: Interventional

Despite being effective in weight reduction in severely obese patients, bariatric surgery (BS) negatively influences bone metabolism and increases the risk of falls thereby potentially increasing the risk of fracture. The mechanisms of BS induced bone loss are unknown but may be related to calcium and vitamin D malabsorption, changes in the energy regulation metabolism and gastrointestinal hormonal physiology. Since the etiology of BS induced bone loss is largely unknown, treatment relies mostly on calcium and vitamin D supplementation, which provide little benefit. Exercise is an effective strategy to prevent bone mass losses in several health conditions. However, no study so far has examined the effects of an exercise-training program in the prevention of BS induced bone loss. The investigators main goal is to investigate the effects on bone metabolism and fracture risk of an exercise-training program specifically tailored to improve bone health and balance of patients that underwent BS. The investigators will perform a randomized controlled trial on obese patients (n=80; BMI>40 Kg.m-2) elected to BS. Patients will be randomly assigned into 2 groups i) a group receiving standard follow-up and medical care, or ii) a group that will undergo a 11 months' Exercise Training program designed to improve bone health and reduce fall risk plus the standard follow-up and medical care. All patients will be assessed i) before the surgery, ii) one month, iii) 6 months, and iv) 12 months after the surgery. Assessments include: biochemical markers of bone turnover (BTM), BMD, bone tissue biomechanical properties, hormones involved in the regulation of energy, gastrointestinal and bone metabolism, body composition, BMI, nutritional intake, balance, muscle strength, cardiorespiratory fitness and daily physical activity. These evaluations will allow the investigators to understand the effects of an exercise-training program on bone metabolism of BS patients, contributing also to further elucidate the mechanisms underlying BS induced bone loss and fracture risk increase. The investigators will use established methods in the literature as well as novel procedures, which will enable them to overcome some of the limitations of previous studies. At the end of the study the investigators expect to have collected consistent data about whether an exercise-training program is or is not able to effectively prevent BS induced bone losses and fracture risk increases.

NCT ID: NCT02802384 Active, not recruiting - Clinical trials for Paget's Disease of Bone

Pathophysiology of Paget's Disease of Bone

Start date: April 2016
Phase:
Study type: Observational

Paget's disease of the bone is a skeletal disorder which results in increased and disorganized bone remodeling, leading to dense but fragile and expanding bones. The identified genetic causes of Paget's disease of bone only explain why bone is destroyed, but not why the bone formed in its place is abnormal. Current treatment for people with Paget's disease of the bone is limited to patients with bone pain, thought to be related to high rate of bone turnover (breakdown and rebuilding of bone) and works by slowing down the rate of bone breakdown. The current treatment does not address the excess blood vessels and bone formed. This research is being done to understand factors that may promote blood vessel and bone formation in Paget's disease of the bone.

NCT ID: NCT02751099 Active, not recruiting - Vascular Disease Clinical Trials

Bone and Cardiovascular Disease After Kidney Transplant

Start date: November 2015
Phase:
Study type: Observational

Bone disorder is a significant problem in chronic kidney disease (CKD), becoming almost universal in stage 5 CKD patients. Besides the healthcare costs, bone disorder is associated with life-threatening complications, including fractures and cardiovascular (CV) events. Kidney transplantation provides circa 68% decrease in mortality and improves co-morbidity. Still, bone disease persists after transplantation. The investigators hypothesize that bone-derived hormones can induce CV events in kidney transplanted patients. Therefore, early evaluation of the bone health is recommended, and prevention of its complications is required. Bone biopsy, an invasive and expensive method, is the gold standard for bone disorders diagnosis. Therefore, non-invasive predictors for bone disease are necessary. Classical biochemical markers of bone formation and resorption have shown a low sensitivity and low specificity. New markers, as fibroblast growth factor 23 (FGF23), and its cofactor klotho, and sclerostin are promising new markers for predicting CKD-associated bone and CV disease after transplantation. This study assesses the phenotype of bone disease after transplantation (given by bone histology) and its correlation with serum FGF23, klotho and sclerostin, in order to evaluate its performance predicting CKD-associated bone and CV disease.

NCT ID: NCT02367846 Active, not recruiting - Clinical trials for Other Disorders of Bone Development and Growth

Assessing the Impact of Contraceptives on Bone Health Using 41Ca

Start date: January 2015
Phase: Phase 4
Study type: Interventional

This preclinical randomized crossover study will examine the effects of oral versus non-oral contraceptive therapy on bone turnover in young exercising women. In an effort to expose the route-dependent effects of oral versus non-oral contraceptive therapy on bone turnover, the investigators will examine 1) the effects of ethinyl estradiol on bone calcium balance using the 41Ca technology and 2) the underlying physiological mechanisms associated with the effects of oral versus non-oral contraceptive therapy on net bone calcium balance.

NCT ID: NCT01922804 Active, not recruiting - Clinical trials for Metabolic Bone Disorder

Investigations of the Effect of MK-7 on Bone and Glucose Metabolism and Arterial Calcification

K2vita
Start date: July 2013
Phase: N/A
Study type: Interventional

The aims of the present study are to investigate the effect of vitamin K2 on bone turnover, bone mass, bone structure, glucose metabolism, and arteriosclerosis. Osteoporosis, diabetes, metabolic syndrome and cardiovascular disease are common diseases that affect large groups of people in the Western world. Our hypotheses is that vitamin K2 (MK-7) reduces undercarboxylated osteocalcin in postmenopausal women and reduces bone turnover and increases bone mineral density; increases insulin sensitivity and decreases indices of arterial calcification.

NCT ID: NCT00150163 Active, not recruiting - Bone Diseases Clinical Trials

Odense Androgen Study: Study of Androgens, Body Composition, and Muscle Function in Danish Men

Start date: March 2002
Phase: N/A
Study type: Observational

Objective: - To define a reference-population of healthy young men (20-29 years old). - To establish reference-intervals for: 1. Total, bioavailable and free serum androgens (testosterone, dihydrotestosterone, androstenedione) and serum estrogens (estradiol, estrone). 2. Total and free IGF-1. - To study the influence of physical activity, alcohol intake, tobacco and abuse of anabolic steroids on serum levels of androgens. - To identify the androgens (or estrogens) that primarily reflect the following parameters: 1. Muscle mass, muscle strength, muscle power, oxygen uptake, and hematocrit. 2. Bone mineral density and bone metabolism. 3. Total and visceral fat mass. 4. Lipid- and glucose metabolism and glucocorticoid metabolism. 5. Sexual function and quality of life. - To study the modifying effect of birth weight, the AR gene CAG-repeat polymorphism, and the level of IGF-1 on associations between serum androgens and the measures above: Ethics, design and schedule: The local ethic review board approved a population-based, cross-sectional study planned for the inclusion of 800 Caucasian men, 20 to 29 year old, living in the County of Funen. The only exclusion criteria were opioid drug addiction, cancer, and severe chronic disease. A basic questionnaire was mailed to 3000 men, randomly drawn from the Danish Central Personal Registry. Adequately answered questionnaires were returned from 2,199 men, who subsequently received an invitation to participate. Informed consent was obtained from 783 men. The examinations started in March 2002 and terminated in May 2003. Within subject variation was determined for all study parameters in 20 men. The men included matched the men answering the questionnaire on all questionnaire items and demographics. All analyses have been performed, except for the additional serum sex hormone assays, IGF-1 assays and AR gene analyses. A sequential rule-out from the reference population was performed on the following criteria: 1. testicular pathology: bilateral cryptorchidism, varicocele, testes volumina < 10 ml (each), history of spermatic cord torsion. 2. severe chronic disease. 3. regular medication or abuse of anabolic steroids. 4. body mass index < 19 kg/m2. 5. safety serum parameters: luteinizing hormone (LH) <1.0 U/L or >8.4 U/l, alanine-amino-transferase (ALAT) >70 U/l and thyrotropin (TSH) >6.0 mU/l.