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Bone Diseases clinical trials

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NCT ID: NCT05735197 Active, not recruiting - Clinical trials for Chronic Kidney Diseases

Effect of Dapagliflozin on Renal Outcomes and Bone Mineral Disease in Non-diabetic Chronic Kidney Disease Patients

Start date: November 10, 2022
Phase: Phase 4
Study type: Interventional

It is a randomized controlled trial in which 100 non diabetic chronic kidney disease (CKD) patient is being participated. Their estimated glomerular filtration rate (eGFR) between 25-75 ml/min/1.73 m2. Participants will be randomized into two groups: - Study group: includes 50 patients, they will receive Sodium glucose co-transporter 2 inhibitor (SGLT2i) as add on drug, Dapagliflozin 10 mg will be used once daily with or without food. - Control group: includes 50 patients, they will receive placebo their medication. The investigators will follow up all patients for 12 months and compare their results. This study aims to: 1. Assess SGLT2i role in delaying the progression of ongoing chronic kidney disease. 2. Study the impact of SGLT2i on bone and mineral metabolism in this patients' population.

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: NCT04019379 Active, not recruiting - Clinical trials for Chronic Kidney Diseases

Calcium and Phosphorus Whole-Body Balance and Kinetics in Patients With Moderate Chronic Kidney Disease

Start date: August 31, 2020
Phase: N/A
Study type: Interventional

This pilot study aims to develop a method for simultaneous whole-body calcium and phosphorus balance and full kinetic modeling of both ions in patients with chronic kidney disease.

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: NCT03571191 Active, not recruiting - Pain Clinical Trials

Denosumab Treatment for Fibrous Dysplasia

Start date: June 13, 2019
Phase: Phase 2
Study type: Interventional

Objectives: The primary objective of this study is to evaluate the effect of denosumab on bone turnover in individuals with fibrous dysplasia (FD). Secondary objectives are to determine the effect of denosumab on bone pain, FD lesion intensity as revealed in 18F-sodium fluoride PET/CT bone scan, and to determine the effect of denosumab discontinuation on bone turnover re-bound after discontinuation. Study Population: Up to 14 adult subjects with FD may be enrolled to ensure complete study data on 9 subjects. Design: This study is a single center, open label pilot study of once-monthly dosing of denosumab. Subjects will be treated for 6 months, after which they will be followed by an 8-month observation period. A final visit will occur 21 months after denosumab discontinuation. Dosing will be adopted from studies in adults on treatment for giant cell tumors, with denosumab administered at 120 mg per dose every 4 weeks, with loading doses on days 7 and 14 of month 1. Outcome Measures: Primary: Assessment of the effects of denosumab on: 1. Markers of bone turnover: Beta-crosslaps C-telopeptides (bone resorption marker) Procollagen-1-propeptide (bone formation marker) Secondary: Assessment of the effects of denosumab on: 1. Bone histomorphometric indices: Mineralized perimeter Bone formation rate Cortical width Cortical area Osteoid width Osteoid perimeter Mineral apposition rate 2. Surrogate markers of a direct therapeutic effect of denosumab on FD lesions: Semi-quantitative changes in RANKL, Ki67 (marker of cell proliferation), p16 (marker of cell senescence), and/or apoptosis index before and after treatment, as assessed by immunohistochemistry Changes in sentinel lesion intensity, measured quantitatively by uptake on 18Fsodium fluoride PET/CT bone scan. 3. FD-related bone pain assessed by the Brief Pain Inventory (Short Form) , a validated self-reporting tool for assessment of pain. Exploratory Endpoints: 1. Effect of denosumab initiation and discontinuation on Serum calcium, phosphorus and parathyroid hormone Serum RANKL and osteoprotegerin (OPG), and RANKL/OPG levels 2. Effect of denosumab discontinuation, as measured by the following outcomes: Biochemical markers of bone metabolism: beta-crosslaps C-telopeptides, procollagen-1 propeptide, bone specific alkaline phosphatase, osteocalcin, NTX-telopeptides 3. Effect measured by change in other outcome measures, such as: Bone density assessed by DXA Physical Medicine and Rehabilitation evaluation

NCT ID: NCT03425994 Active, not recruiting - Kidney Injury Clinical Trials

Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide as Maintenance Treatment for HIV/HBV-coinfection

Start date: February 6, 2018
Phase:
Study type: Observational [Patient Registry]

Tenofovir alafenamide (TAF), active against both HIV and HBV, demonstrates similar antiviral efficacy but improved renal and bone safety compared to tenofovir disoproxil fumarate (TDF) in HIV-1-infected patients. HIV-1-infected patients whose estimated glomerular filtration rate (eGFR) between 30-69 mL/min were shown to have minimal change in eGFR and improved proteinuria, albuminuria, and bone mineral density after switching to a single-tablet regimen containing Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (EVG/cob/FTC/TAF). For treatment of chronic HBV infection, a similar proportion of HBV-monoinfected patients who received TAF and those who received TDF achieved undetectable HBV DNA at 48 weeks of therapy. Although TAF is effective for HIV and HBV suppression, data on efficacy of TAF are limited among patients co-infected with both viruses. Currently, only one open-label, single-arm study had investigated the efficacy and safety of TAF in HIV/HBV-coinfected patients. In this study, 72 HIV/HBV-coinfected patients switching to EVG/cob/FTC/TAF were enrolled, and 91.7% of them maintained or achieved virologic suppression for both HIV and HBV at 48 weeks of therapy. Seroconversion occurred in 2.9% of HBsAg-positive participants and in 3.3% of HBeAg-positive participants. Improvements in eGFR and declines in markers of bone turnover of the participants were observed. The limitations of the above study are the small sample size. Taiwan is a country hyperendemic for HBV infection, with 19.8% of HIV-positive patients who were born before the implementation of nationwide neonatal vaccination in 1986 had concurrent chronic HBV infection. To further the understanding of the difference between TAF- and TDF-containing combination antiretroviral therapy among HIV/HBV-coinfected patients, the investigators plan to conduct an observational study to evaluate the efficacy and safety of EVG/cob/FTC/TAF as maintenance treatment of HIV/HBV-coinfected patients.

NCT ID: NCT03285854 Active, not recruiting - Clinical trials for Chronic Kidney Disease Mineral and Bone Disorder

Calcium Balance Studies in Children With CKD and on Dialysis

Cal-Bal
Start date: February 1, 2017
Phase:
Study type: Observational

This is a novel, non-invasive method of assessing Ca balance by natural Ca isotope fractionation.

NCT ID: NCT03108222 Active, not recruiting - Clinical trials for Chronic Kidney Disease Mineral and Bone Disorder

Phosphorus Absorption in Healthy Adults and in Patients With Moderate Chronic Kidney Disease

Start date: April 25, 2018
Phase:
Study type: Observational

Chronic kidney disease (CKD) affects approximately 26 million Americans with many more at risk for disease development. Elevated serum phosphorus (P) and related abnormalities in P homeostasis due to progressive loss of kidney function are primary driving forces behind cardiovascular dysfunction and mortality in CKD patients. Intestinal P absorption is an critical aspect in P homeostasis but has been understudied, particularly in the early stages of CKD progression. This study aims to determine P absorption in patients with moderate CKD compared to healthy adults.

NCT ID: NCT02880319 Active, not recruiting - Bone Cancer Clinical Trials

Evaluating Stereotactic Body Radiation Therapy for Oligometastatic Disease of the Bone

Start date: November 29, 2016
Phase: Phase 2
Study type: Interventional

This research study is studying a form of radiation therapy called stereotactic body radiation therapy or SBRT as a possible treatment for Cancer that has spread to the spine or other bone