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Bone Mineral Density clinical trials

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NCT ID: NCT02491008 Completed - Osteoporosis Clinical Trials

Novel Biomarkers and Skeletal Outcomes Associated With Subclinical Thyroid Dysfunction

TRUST BONE
Start date: January 2014
Phase: Phase 4
Study type: Interventional

Thyroid hormone is a key regulatory hormone for a range of physiological systems, including the skeleton. Previous studies have suggested that subclinical thyroid dysfunction (SCTD) may be associated with deleterious skeletal effects. However, controversy persists on the clinical relevance of SCTD as well as on optimal thresholds for treatment. Available data have substantial limitations: 1) limited prospective data are available to assess the associations between SCTD and non-cardiovascular outcomes, such as fractures 2) lack of data from large RCTs to investigate the pathophysiological mechanisms of associations between thyroid hormone and bone loss. The aim of the study is to examine the relationship between subclinical hypothyroidism and thyroid hormone replacement in regard to skeletal fragility, bone mineral density (BMD), bone loss and metabolism, and the risk of fractures in elderly participants. The listed parameters will be assessed by dual energy X ray absorptiometry (DXA) and novel bone imaging techniques at baseline, at 1 year of follow-up. The study will be nested in the TRUST trial (clinicaltrials.gov ID: NCT01660126), and will make use of its study infrastructure to determine bone biomarkers from biospecimens at baseline, and at 1 year of follow-up from 145 Swiss participants with persistent subclinical hypothyroidism randomized to either thyroxine or placebo in Bern and Lausanne.

NCT ID: NCT02480023 Completed - Clinical trials for Bone Mineral Density Quantitative Trait Locus 3

Assessment of Bone Mineral Density During Pregnancy

Start date: June 2015
Phase: Phase 1
Study type: Interventional

BMD at peripheral sites typically heel is measured by Ultrasound densitometry at Ain Shams Maternity hospital.

NCT ID: NCT02179268 Completed - Clinical trials for Bone Mineral Density Quantitative Trait Locus 7

Antidepressants and Bone Mineral Density

Start date: March 2012
Phase: Phase 3
Study type: Interventional

The aim of this five arm randomized trial was thus to compare selective serotonin reuptake inhibitor (SSRI)sertraline and citalopram to a dual reuptake inhibitor venlafaxine, a nor-adrenaline reuptake inhibitor reboxetine and a control group receiving placebo, with the primary endpoint being bone mineral density, and secondary endpoints being bone turnover markers.

NCT ID: NCT02162602 Completed - Clinical trials for Bone Mineral Density Reference Data

Bone Mineral Accretion in Young Children

Start date: May 2014
Phase:
Study type: Observational

Compromised bone strength and increased fracture susceptibility pose significant morbidity and health care costs in children. Inadequate childhood bone accretion also may have lifelong consequences. Bone fragility among children with chronic medical conditions is a special concern. Identifying children at-risk for bone fragility and factors affecting bone strength requires understanding normal bone development. Dual energy x-ray absorptiometry (DXA) is the most common method for measuring bone mineral content and bone density in children. There are bone density reference data for children ages 5-20 years. An important gap is the lack of reference data for children ages < 5 years, who also experience numerous medical conditions that threaten their bone health. Growth and body composition influence bone mineral accrual, and are important for interpreting bone density measurements in children with conditions that threaten bone health. Gross motor skills and subsequent physical activity may also affect bone accrual. Children with chronic illness are at risk of altered body composition, delayed growth and gross motor skills, and restricted physical activity. Understanding independent effects of growth, body composition, gross motor skills and physical activity on bone accrual will improve interpretation of bone density measurements and has important research and clinical applications for identifying risk factors and therapies for young children. This study will involve a longitudinal cohort of 280 children studied every 6 months for 3 years, and a cross-sectional cohort of 240 children measured once. The study will be conducted at 2 clinical centers [Cincinnati Children's Hospital Medical Center (CCHMC) and the Children's Hospital of Philadelphia (CHOP)] with equal enrollment at both centers. Measurements will include bone density, growth and body composition, dietary intake, sleep, physical activity and gross motor skills. Results from this study will enable clinical bone health assessment of young children with disorders that threaten bone health, and identify factors that affect bone accrual.

NCT ID: NCT02064946 Completed - Prostatic Neoplasms Clinical Trials

High-dose Vitamin D Supplementation for ADT-induced Side Effects

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

The purpose of this study is to test the efficacy of a high-dose vitamin D supplementation regimen in reducing androgen deprivation therapy (ADT)-related side effects in older prostate cancer patients on ADT. The proposed study is a randomized, double-blind, 2-arm, controlled clinical trial that will accrue 76 prostate cancer patients without severe bone loss, aged 60 and older, beginning ADT, and scheduled to receive at least 6 months more of ADT. Participants will be randomized to: 1) weekly high-dose vitamin D3 (50,000 IU) or 2) vitamin D placebo only for a period of 24 weeks. Both groups will also receive a daily multivitamin and calcium supplement.

NCT ID: NCT01544660 Completed - Clinical trials for Bone Mineral Density

Bone Quality by vQCT and HR-pQCT:Translation to Multi-center Clinical Research

Interscanner
Start date: April 2012
Phase: N/A
Study type: Observational

Our overarching aim is to set up a procedural, analytic and developmental framework to establish CT of the central and peripheral skeleton as a clinically useful biomarker for skeletal strength in the clinical research and ultimately in the clinical setting. To accomplish this, the investigators will develop and validate phantoms and scanning procedures to standardize strength and structure measurements between different vQCT scanners and develop standardized acquisition, analytical, and quality control techniques for HR-pQCT with an emphasis on optimization for multi-center studies.

NCT ID: NCT01041898 Completed - Clinical trials for Bone Mineral Density

The Bone-Fat-Pancreas Axis in Children

Start date: December 2009
Phase:
Study type: Observational

The overarching hypothesis of this proposal is that obesity and positive energy balance in children promote both low bone mass accrual and risk for diabetes through events that are mechanistically associated and that involve bone as an endocrine organ. Recent studies conducted in mice have uncovered the presence of a unique "bone-fat-pancreas" axis that regulates energy homeostasis, coordinates energy partitioning between bone and adipose tissue, and impacts insulin sensitivity. The adipocyte-derived hormone leptin, elevated levels of which reflect both adiposity and positive energy balance, inhibits bone formation via sympathetic activation. Decreased bone formation in turn depresses insulin sensitivity and secretion via decreased production of undercarboxylated osteocalcin (unOC), a novel bone-derived hormone. Although data from mice are compelling, this novel pathway has not been widely tested in humans. Sparse data from adult men and women suggest that this axis is active in humans, and that unOC is regulated in part by exercise. No data are available regarding the bone-fat-pancreas axis in children. Because the foundations of body composition trajectories and metabolic "programming" are established early in the life course, childhood, particularly during early stages of growth and development, is an especially salient time period for evaluating the bone-fat-pancreas axis. With this pilot grant, we propose to gather evidence that these interrelationships exist in children. The data from this project will be used to prepare an NIH R01 proposal to conduct a lifestyle-based intervention in children aimed both at reducing risk for osteoporosis and type 2 diabetes, and at identifying the role of unOC in metabolism and tissue partitioning. Hypothesis 1: Obesity and positive energy balance in children decrease bone mass via elevated leptin. Specific Aim 1: Determine the association between bone mass by DXA and serum leptin concentration in lean and obese children. We predict that body weight will be positively associated with bone mass, but that at any given body weight, bone mass will be lower in obese children, and that this difference will be explained by leptin. Hypothesis 2: Leptin-mediated suppression of unOC decreases insulin secretion through action on the β-cell, and decreases insulin sensitivity by inhibiting secretion of adiponectin from adipose tissue. Specific Aim 2: Determine the association between insulin secretion during oral glucose tolerance test (OGTT; from C-peptide modeling) and serum unOC in lean and obese children. Determine the association between insulin sensitivity during OGTT (derived from mathematical modeling) and serum unOC in lean and obese children. Obese children are less insulin sensitive, and in an absolute sense, secrete more insulin. However, we predict that at any given degree of insulin sensitivity, insulin secretion will be lower in obese children, and that this difference will be explained by unOC. unOC will be inversely associated with serum leptin, and will be positively associated with adiponectin and insulin sensitivity. Hypothesis 3: Physical activity prevents leptin suppression of unOC and partitions energy towards bone mineral at the expense of bone marrow adipose tissue. Specific Aim 3: Assess the interrelationships among physical activity using accelerometry, bone mass using DXA and bone marrow adipose tissue using magnetic resonance imaging. We predict that at any given level of serum leptin, active children will have greater unOC. Further, we predict that at any given body weight, active children will have greater bone mass and lesser bone marrow adipose tissue than inactive children.

NCT ID: NCT01010230 Completed - Clinical trials for Bone Mineral Density

Vibration Intervention For Bone Enhancement In Childhood Cancer Survivors

Start date: May 2010
Phase: N/A
Study type: Interventional

Treatment for childhood cancer interferes with normal bone maturation such that maximal peak bone mass may never be attained by some survivors of childhood cancer. In childhood cancer survivors, a randomized trial evaluating the effectiveness of vitamin D and calcium supplementation among ALL survivors is currently underway; however, few other interventions have been offered for this at risk population. Recent evidence demonstrates that low magnitude; high frequency mechanical stimulation can improve bone quantity and quality, perhaps providing an alternative or adjunct to pharmacologic intervention in populations where additional medications are either contraindicated or not acceptable to the individuals at risk. This application proposes a prospective double blind randomized clinical trial of low magnitude, high frequency mechanical (LMHF) stimulation for childhood cancer survivors whose bone mineral density is one or more standard deviations below the mean for their age and gender.

NCT ID: NCT00924560 Completed - Clinical trials for Bone Mineral Density

A Multicenter Study to Evaluate the Effects of a 91-day Oral Contraceptive on Bone Mineral Density in Adolescent Females

Start date: June 2009
Phase: Phase 2
Study type: Interventional

This study is being conducted to compare the effects of a 91-day oral contraceptive (OC) to a 28-day OC regimen on bone mineral density (BMD) in adolescent females.

NCT ID: NCT00655577 Completed - Osteoporosis Clinical Trials

Exercise and Prevention of Hip Fractures

Start date: August 1998
Phase: N/A
Study type: Interventional

The significance of this population-based study is in producing new information for planning interventions and rehabilitation programs for the elderly, planning education of health care personnel and planning national health education programs for different age groups. The study consists of an epidemiological cross-sectional study and a randomized controlled intervention study. The study population consisted of all the 1689 home-dwelling women born during 1924-1927 residing in Oulu, Northern Finland, who were asked to a screening visit including bone mineral density (BMD) measurement of the distal radius in 1997. 1222 women attended the clinic and were afterwards mailed a postal questionnaire focusing on lifelong risk factors for osteoporosis, e.g. the amount of physical activity at work and during leisure time, daily intake of calcium and use of alcohol and cigarettes. Those with BMD value more than 20% lower than the reference value, underwent a densitometry of the hip. All women with femoral neck BMD more than 20% below the reference value (n=160) were randomly selected to either exercise (n=84) or control (n=76) group. At baseline and after that annually during the 30-month intervention, balance, muscle strength, aerobic capacity, walking speed, cognitive functions and mood are measured from all the participants. Hip BMD will be measured annually. The exercise group participates in a supervised training program with weekly sessions from the beginning of October to the end of April. In addition to the supervised sessions the participants train daily at home. From April to October the exercises are performed purely at home. The training regimen consists of balance, strength and impact exercises. The intervention group keeps diary of their daily physical activity. The number and severity of falls are recorded from both the groups. The purpose of the study is: 1. to identify factors accounting for low BMD in elderly home-dwelling women with severe osteopenia. 2. to evaluate how supervised regular weight-bearing exercise program affects BMD in elderly home-dwelling women with severe osteopenia 3. to evaluate how supervised regular balance and muscle training affects balance and muscle strength in elderly home-dwelling women with severe osteopenia. In addition the aim is to: 4. study how regular supervised exercise affects the incidence and severity of falls, mood and cognitive functions in women with severe osteopenia. Hypothesis and research methods The main hypothesis is that long-term supervised, mainly home- based regular impact-type and balance and muscle exercises can improve balance and muscle strength of lower extremities and maintain bone mass in elderly women. We also hypothesize that the incidence of falls is lower in the exercise group than in the controls and that the falls are more injurious in the control group than in the intervention group during the follow-up period