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Bone Diseases, Metabolic clinical trials

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NCT ID: NCT04779216 Active, not recruiting - Anorexia Nervosa Clinical Trials

Effects of Romosozumab on Bone Density in Women With Anorexia Nervosa

Start date: September 20, 2021
Phase: Phase 3
Study type: Interventional

This protocol is a randomized, double-blind, placebo-controlled clinical trial which aims to investigate the effect of romosozumab on BMD in women with anorexia nervosa. The investigators will also investigate the safety of romosozumab in women with anorexia nervosa. The investigators hypothesize that 12 months of romosozumab administration will result in an increase in bone mineral density, increase in markers of bone formation and decrease in markers of bone resorption, and improvement in bone microarchitecture in osteopenic women with anorexia nervosa compared with placebo. The extension study will offer subjects 12-month administration of open-label alendronate (an oral bisphosphonate) 70 mg once weekly after the initial 12 month administration of romosozumab or placebo. The investigators hypothesize that 12 months of romosozumab followed by 12 months of open-label alendronate will result in a greater increase in BMD compared to 12 months of placebo followed by 12 months of open-label alendronate. Within the group of women who receive sequential therapy with 12 months of romosozumab followed by 12 months of alendronate, the investigators hypothesize that BMD will be maintained between 12 and 24 months while on alendronate.

NCT ID: NCT04708886 Active, not recruiting - Osteoporosis Clinical Trials

Romosozumab in Women With Chronic SCI

Start date: March 1, 2021
Phase: Phase 2
Study type: Interventional

This two-year open-label pilot clinical trial will evaluate the efficacy and safety of romosozumab to treat bone loss in females with chronic spinal cord injury (SCI) and osteoporosis (OP). Participants will receive monthly injections of romosozumab during the first 12 months of the study. During the second year, participants will take oral alendronate tablets on a weekly basis.

NCT ID: NCT04439747 Active, not recruiting - Clinical trials for Chronic Kidney Diseases

Develop and Implement Methods for Diagnostic and Treatment of Hormonal Disorders in Patients With Chronic Kidney Disease

Start date: January 1, 2018
Phase:
Study type: Observational

Methods of diagnostic and treatment of hormonal disorders in patients with chronic kidney disease (CKD) will be developed and implemented in real clinical practice. As a result of the project, new scientific data will be obtained on the relationship of hyperprolactinemia and impaired functioning of the pituitary-gonadal axis, changes in functioning of the renin-angiotensin-aldosterone system will be revealed, and the characteristics of the thyroid and parathyroid status in patients with CKD will be determined, including receiving renal replacement therapy (RRT) and after kidney transplantation, which will improve the efficiency of diagnosis and treatment of hormonal disorders in the early stages of the disease, reduce the direct financial costs of the diagnostic and treatment process primarily due to the optimization of hormonal studies and treatment of the revealed disorders, as well as will prevent the progression of CKD and the severity of the condition of this category of patients due to the development of hormonal dysfunctions.

NCT ID: NCT04342078 Active, not recruiting - Lung Diseases Clinical Trials

Vitamin D and Health Outcomes in Preterm Born Population

ViDePrePop
Start date: September 1, 2018
Phase:
Study type: Observational

Improved survival of very preterm newborn population during the last decades has challenged us neonatologists to study and improve nutritional practices including vitamin D (VitD) supplementation. However, long term outcome in this aspect has not been researched in well documented preterm populations. As VitD has receptors in almost all human cells it modulates growth of many organs. Therefore I start to assess VitD supplementation practices and later health outcome (bones, teeth, muscles, heart, lungs) in two preterm population cohorts cared in Oulu University Hospital at the age of 5 years and 24 years (born 2014-2017 and 1994-1997).

NCT ID: NCT04233112 Active, not recruiting - Osteopenia Clinical Trials

Melatonin and Osteogenic Loading on Osteopenia

MelaOstrong
Start date: May 26, 2020
Phase: Early Phase 1
Study type: Interventional

This study will be assessing the efficacy of melatonin and/or osteogenic loading on modulating bone health in an osteopenic population.

NCT ID: NCT04087096 Active, not recruiting - Clinical trials for Bariatric Surgery Candidate

Denosumab to Prevent High-Turnover Bone Loss After Bariatric Surgery

Start date: August 24, 2020
Phase: Phase 4
Study type: Interventional

Bariatric surgery leads to bone loss and increases fracture risk. This study evaluates whether denosumab can prevent the high-turnover bone loss that occurs after Roux-en-Y Gastric Bypass (RYGB) and sleeve gastrectomy (SG) surgery.

NCT ID: NCT04018287 Active, not recruiting - Clinical trials for Bone Diseases, Metabolic

Circulating miRNAs and Bone Microstructure in Adults With Hypophosphatasia

Start date: August 1, 2017
Phase:
Study type: Observational

The aim of the study is to accomplish a complete bone status of patients with HPP using new approaches to assess bone quality.

NCT ID: NCT03986203 Active, not recruiting - Osteopenia Clinical Trials

Evaluation of the Spry Belt for Improving Bone Quality

Start date: August 13, 2019
Phase: N/A
Study type: Interventional

The purpose of this research study is to evaluate the safety and effectiveness of the Spry Belt. The Spry Belt is intended to deliver energy to the user's skeleton to reduce the progression of age-related decrease in bone quality in postmenopausal women. Half of the participants will receive the active treatment, while the other half will receive the sham/placebo treatment.

NCT ID: NCT03354988 Active, not recruiting - Clinical trials for Osteopenia Prematurity

Effect of Assisted Exercise on Musculoskeletal System and Growth in Preterm Infants

Start date: January 2015
Phase: N/A
Study type: Interventional

The primary aim of this study is to assess whether physical activity programs in preterm infants improve bone mineralization as well as growth and reduce the risk of fractures. The secondary aim is to include other potential benefits in terms of length of hospital stay, weaning from mechanical ventilation, feeding tolerance and adverse events

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.