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Osteoporosis clinical trials

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NCT ID: NCT03648775 Terminated - Osteoporosis Clinical Trials

Evaluation of the Clinical Efficacy of Y-STRUT® Medical Device Implanted for Contralateral Percutaneous Internal Fixation of Proximal Femur, in Patient With a Low Energy Per Trochanteric Fracture on the First Side

Start date: December 6, 2017
Phase:
Study type: Observational

HIP50 is a national, multicentre, prospective, observational study, in patients presenting a first low energy per trochanteric hip fracture on one side and treated with Y-STRUT® device implanted on the contralateral proximal femur as percutaneous internal fixation to prevent contralateral hip fracture in case of osteoporosis. The primary objective of this study is to evaluate the clinical efficacy of the studied medical device by measuring the frequency of patient with a fracture at the implantation site within 1 year after implantation. A total of 50 patients from France will be enrolled (until December 2020) and followed up to 24 months.

NCT ID: NCT03484208 Terminated - Clinical trials for Osteoporotic Fractures

Evaluation of a Fracture Liaison Service in the Osteoporosis Care

Start date: February 8, 2018
Phase:
Study type: Observational

The St JOSEPH'S HOSPITAL set up a fracture liaison service for osteopotic fracture. A specific nurse screens eligible patient admitted in emergency yard and call them to propose a bone densitometry and a medical coverage.. The aim of the study is to evaluate this new organisation

NCT ID: NCT03457818 Terminated - Clinical trials for Diabetes Mellitus, Type 2

Therapy of the Skeletal Disease of Type 2 Diabetes With Denosumab

Start date: November 7, 2018
Phase: Phase 2
Study type: Interventional

The goal of the study is to characterize the effect of Prolia® (denosumab) on indices of bone strength in type 2 diabetes (T2D). The investigational plan involves administration of Prolia® or identical placebo for 12 months as a randomized double-blind placebo-controlled trial in 66 T2D postmenopausal women assigned to Prolia® or placebo. The study will include assessment of different measures of bone quality: skeletal microarchitecture, including measurement of skeletal cortical pores; bone mineral density; bone material quality, and accumulation of advanced glycation endproducts (AGEs) in collagen. This information will help to determine whether Prolia® treatment in type 2 diabetes has skeletal benefits.

NCT ID: NCT03165747 Terminated - Clinical trials for Menopausal Osteoporosis

Effect of VSL#3 on Bone Mineral Density in Postmenopausal Women

ProBoneVSL
Start date: October 1, 2017
Phase: Phase 2
Study type: Interventional

Osteoporosis has a devastating impact on quality of life of postmenopausal women, and is a significant cause of disability and morbidity. Many drugs are approved for the prevention and treatment of osteoporosis, but are associated with high costs and side effects. Some data from animal studies suggests that supplementation with probiotics can safely treat and prevent osteoporosis. The probiotic VSL#3 is commercially available, is safe for human consumption, and has been widely used in human clinical trials, and has known health-promoting effects in both children and adults. The double-blind, randomized, placebo-controlled trial of VSL#3 will be conducted for 12 months in 40 postmenopausal women to determine if VSL#3 improves bone mineral density and related bone markers. Study visits will include all or some of the following procedures: a medical exam, urine collection, height and weight measurement, a blood draw to assess bone biomarkers, a DEXA (dual energy X-ray absorptiometry) scan to measure bone density, and health questionnaires. This is one of the first clinical trials proposed to investigate the effects of probiotics in bone in humans. If successful, this proposal will provide the first evidence that nutritional supplementation with the probiotic VSL#3 is a safe and effective strategy for preventing postmenopausal bone loss.

NCT ID: NCT03154684 Terminated - Osteoporosis Clinical Trials

Spitex-SpiTal-Autonomie-Reha-Kraft

STARK
Start date: May 5, 2017
Phase: N/A
Study type: Interventional

The primary purpose of this study is to test if the STARK comprehensive autonomy health care package improves lower extremity function over time at 6 weeks, 3, 6 and 12 months after hip or pelvis fracture compared to the standard of care.

NCT ID: NCT03040765 Terminated - Osteoporosis Clinical Trials

Denosumab Versus Zoledronic Acid in Thalassemia-Induced Osteoporosis

DOHA
Start date: May 14, 2018
Phase: Phase 3
Study type: Interventional

This study is to compare the two medications Denosumab and Zoledronic Acid For Patients With Beta Thalassemia Major Induced Osteoporosis. Patients with B-thalassemia major induce osteoporosis will undergo baseline assessment of the bone densitometry by Dual-energy X-ray absorptiometry scan as a standard of care by the radiology department, then a blood test for bone specific Alkaline phosphatase and type-1 Carboxy Telopeptide will be measured by the chemistry lab. Patients with B-Thalassemia Major induced osteoporosis, who are 18 years of age or more and willing to participate in the study will be enrolled after consenting by the primary investigator in hematology outpatient clinic. Patients with osteoporosis will receive one of the two medications, at the end of the year Dual-energy X-ray absorptiometry scan will be done to compare the response of the two medications. The potential risks include the drug-related side effects

NCT ID: NCT03029442 Terminated - Spinal Cord Injury Clinical Trials

The Efficacy of Denosumab in Incomplete Patients Spinal Cord Injury

Start date: April 1, 2017
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine the usefulness of a drug, denosumab, to prevent the loss of bone in participants legs due to SCI. This drug is FDA approved to treat osteoporosis in women after menopause who have an increased risk for fractures, to treat women receiving certain treatments for breast cancer who have an increased risk of fractures, and to treat bone loss in men receiving certain treatments for prostate cancer who have increased risk for fractures. This drug is considered experimental for the purpose of this study. Study participation will last for approximately 12 months (6 study visits total), visits will range from1-4.5 hours depending on the number of tests that need to be completed. The study is a double-blinded placebo trail in which the participant will be randomly assigned to on of two groups, Denosumab injections or placebo - inactive salt solution injections.

NCT ID: NCT02792413 Terminated - Clinical trials for Female With Osteoporosis and Chronic Kidney Disease

Study Evaluating Denosumab on Bone and Vascular Metabolism in Osteoporotic Chronic Kidney Disease

HDENO
Start date: November 19, 2018
Phase: Phase 4
Study type: Interventional

Aim of this study is to evaluate in a population of old osteoporotic chronic kidney disease females the effect of denosumab: - on bone mineral density (femoral T-score) at 24 months - on bone mineral density evolution (femoral T-score) after 24 months of follow-up - on bone mineral density evolution (lumbar T-score) after 24 months of follow-up - on coronary and abdominal aorta calcification scores evolution after 24 months of follow-up - on parameters of bone remodelling (OPG, RANKL, sclerostin, DKK-1), of mineral and calcium metabolism (FGF23 Ct, Klotho, PTH, 25(OH) vitamin D3, phosphorus, calcium, bone alklaline phosphatase, osteocalcin, CTX), of inflammation (CRP) after 24 months of follow-up - on cardiovascular morbidity (cardiovascular events) and mortality after 24 months of follow-up - the tolerance after 24 months of follow-up

NCT ID: NCT02734719 Terminated - Osteoporosis Clinical Trials

Increasing Bone Density by Application of Surface Electrical Stimulation

Start date: October 1, 2021
Phase: N/A
Study type: Interventional

Bonestim system for osteoporosis treatment uses surface electrical stimulation of neuromuscular and skeletal tissue by multipad stimulation electrodes for inducing contractions of the spinal column muscles. The primary aim of this clinical study is to determine if the Bonestim therapy can improve bone density. A secondary aim is to determine whether the applied treatment increases postural stability and facilitation of daily life activities. Inducing of contractions of the spinal column muscles in this manner could be new treatment options for the patients with reduced mobility and the patients with serious contraindications for drugs.

NCT ID: NCT02532439 Terminated - Osteoporosis Clinical Trials

Bone Microarchitectural Database Constitution From HR-pQCT Device in Clinical Situation Potentially Associated With Bone Loss

DMPOs
Start date: March 18, 2015
Phase: N/A
Study type: Interventional

Bone fracture occurrence is associated with an increasing of morbidity and mortality. Some factors of fracture occurrence have been highlighted. For example, some diseases or therapy are known to increased risk of bone fracture only in some patients. Accordingly, it is important for clinicians to identify patients at risk for bone fracture. Right now, various tools are available for the clinicians: - clinical exam, - bone mineral density assessed by Dual Energy X-ray Absorptiometry (DEXA), - an algorithm based on interrogation, clinical exam and bone mineral density. However, prediction of bone fracture risk needs to be improved since only 50% of bone fractures can be predicted. DEXA provides information for fracture risk estimation, but it is unable to distinguish cortical part to trabecular part. It also fails to quantify the microstructural properties that influence bone strength. Bone microarchitecture, including the cortical compartment can now be assessed in vivo by the HR-pQCT. This technique allows access to several parameters: on the one hand the volumetric bone mineral density for the whole area measured as well as cortical and trabecular regions, and on the other hand, the thickness and cortical porosity and the number of trabecular, their orientation and distribution. Thus, the HR-pQCT allows realizing a virtual bone biopsy and provides information on cortical and trabecular bone microarchitecture. This is the only noninvasive way to assess cortical and trabecular bone microarchitecture.