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Osteoporosis clinical trials

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NCT ID: NCT03648775 Recruiting - 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 2018) and followed up to 24 months.

NCT ID: NCT03623633 Not yet recruiting - Osteoporosis Clinical Trials

Comparative Antiresorptive Efficacy Discontinuation of Denosumab

Start date: September 1, 2018
Phase: Phase 4
Study type: Interventional

Osteoporosis remains a significant healthcare burden for the United States. Current FDA-approved osteoporosis treatments include teriparatide, abaloparatide, bisphosphonates, denosumab, and raloxifene. Denosumab is a fully human monoclonal antibody that specifically binds to receptor activator of nuclear factor kappa-B ligand (RANKL). Denosumab potently suppresses osteoclastic activity but bone turnover rapidly normalizes and bone turnover marker levels can rebound above baseline levels after the drug is discontinued. The proposed study will help us determine the relative efficacy of two oral antiresorptive medications that are FDA-approved for treatment of postmenopausal osteoporosis (alendronate and raloxifene) in preventing the rebound increase in bone turnover that occurs after denosumab discontinuation.

NCT ID: NCT03605173 Recruiting - Osteoporosis Clinical Trials

Study on the Correlation of Free Vitamin d With BMD and Fracture

Start date: March 1, 2018
Phase: N/A
Study type: Interventional

According to the free hormone hypothesis, the biological activity of a hormone is carried by the portion that is not bound to protein or its carrier in circulation. Based on this, we believe that the free vitamin d, which is the proportion of Vitamin D unbound to vitamin D binding protein and albumin, performs the calcium-regulating functions of the vitamin. Hence, our objective is to study whether free vitamin correlated better with BMD and fracture than the total vitamin D.

NCT ID: NCT03600675 Recruiting - Osteoporosis Clinical Trials

Determinants of Bone Mineral Density and Metabolic Syndrome in South Asian Indian Men

Start date: May 8, 2015
Phase:
Study type: Observational

This study aims to examine the association between body composition with bone density and risk factors for cardiovascular disease and type 2 diabetes. South Asian Indians have a lower bone density and a higher likelihood to develop metabolic syndrome (MetS) compared to Caucasians. MetS is a cluster of metabolic abnormalities that predispose an individual to cardiovascular disease and type 2 diabetes. This study will understand if the metabolic and biochemical markers ( Indicators of bone building and breaking in the blood and urine, Lipids and other proteins) explain both low BMD and MetS in SAI men

NCT ID: NCT03598556 Recruiting - Osteoporosis Clinical Trials

Preventing Bone Loss Among Chinese Patients With HIV on ART

Start date: June 1, 2018
Phase: N/A
Study type: Interventional

The major goal of this study will be to conduct a randomized, double-blind, placebo-controlled, clinical trial of intermittent high-dose vitamin D3 supplementation (180,000IU) given at the point of care (every 3 months) after initiation of ART with tenofovir/ lamivudine/ efavirenz to compare its ability to mitigate reductions in bone mineral density over 12 months compared to placebo.

NCT ID: NCT03570177 Not yet recruiting - Clinical trials for Fractures Related to Skeleton Fragility

Fracture Prediction by Opportunistic Screening for Osteoporosis

OPPORTOS
Start date: August 1, 2018
Phase:
Study type: Observational

Fractures related to skeleton fragility (i.e. osteoporotic fractures) represent a growing health problem, as the life expectancy and thus the number of frail elderly subjects is increasing. These fractures are associated with individual and societal consequences. The fractures are responsible for increased disability, chronic pain, and loss of independency. The annual cost of either prevalent or incident osteoporotic-related fractures exceeds the same ratio calculation for many other serious chronic diseases. Mortality risk is increased following osteoporotic fractures. Several classes of osteoporosis therapies are proven to reduce fracture risk, based on placebo controlled trials of 3-5 years duration, including in elderly patients. These data are the rationale for screening of patients at risk of fracture, recognizing that the optimal approach is to identify subjects at risk for major fractures . Bone fragility is related to the decrease of both the quality and the quantity of bone. Bone mineral density (BMD) is a surrogate of bone fragility, with the advantage of being non-invasively measurable, at relevant sites, such as vertebrae and upper extremity of the femur. A low BMD, age, and prevalent fractures are the 3 main determinants of the risk of sustaining a fracture. A low BMD has also been reported as a determinant of all cause mortality risk in the general population. So far, screening of low BMD by QCT has not been recommended because of low availability of the devices, irradiation, and cost. However, a huge number of QCT are performed daily for various medical indications. These thoracic and abdominal QCT carry potential information about vertebral BMD. These data are already available, with no additional cost, patient time, nor radiation exposure. They can be retrospectively (in our study) or prospectively (in the future context of care) analyzed, and are the basis of an opportunistic screening for osteoporosis: this denotes the use of diagnostic QCT scans made for other medical indication to screen for patients at high fracture risk. There is no study of this QCT based measurement as an opportunistic screening for patients at short-term risk for fracture. Opportunistic screening of osteoporosis, by diagnosis of low BMD on abdominal QCT performed for various medical indications, is able to detect subjects at short-term (i.e. over 3 years) risk of fracture (necessitating an hospitalization).

NCT ID: NCT03563235 Not yet recruiting - Clinical trials for Postmenopausal Osteoporoses

Clinical Study on Treatment of Postmenopausal Osteoporosis (Kidney Deficiency and Blood Stasis Syndrome) With Xulin Jiangu Granules

CSOPOPWXJG
Start date: September 1, 2018
Phase: Early Phase 1
Study type: Interventional

Osteoporosis is a common senile disease with a high incidence. The Chinese medicine differentiation treatment has small side effects and can be taken for a long time, which has certain advantages. This project adopts the experience of the person in charge of the project-Xulin Jiangu Granules and clinically collects patients with postmenopausal osteoporosis (kidney deficiency and blood stasis syndrome).

NCT ID: NCT03537846 Completed - Osteoporosis Clinical Trials

Osteoporosis Awareness Survey of Women in Champagne Ardenne

MPCosteoporose
Start date: March 19, 2018
Phase:
Study type: Observational

Osteoporosis is characterized by low bone mineral density and alterations in bone microarchitecture, leading to bone fragility and high risk of fractures. In the peri-menopausal period and during menopause, estrogen deficiency is responsible for an acceleration of bone remodeling. It is therefore important to sensitize women to this pathology at the beginning of menopause. Osteoporosis is a public health issue with more than 3 million women in France suffering from almost ¼ of the population over 50 years old. Paradoxically, the number of bone densitometry and prescribed osteoporosis drugs are decreasing. There is an under-screening and a disinterest of the pathology on the part of the medical world and the patients. The investigators hypothesize that women lack knowledge about osteoporosis. This study will identify these gaps, and put in place appropriate strategies to improve this knowledge. For this purpose, a descriptive cross-sectional observational study will carry out, through the fulfillment of self-administered questionnaire for women over 30 years old. The main objective is to assess the knowledge of women, about osteoporosis and its consequences. The judgment criterion is based on a percentage of correct answers per question. The interests of the study are to identify gaps in knowledge, to optimize the investigator's therapeutic education, to fight patient wait-and-see and false beliefs, and finally to improve adherence and longer-term adherence.

NCT ID: NCT03534934 Not yet recruiting - Osteoporosis Clinical Trials

CT-Based Modeling of Bone Micro-Architecture and Fracture-Risk in COPD

Start date: June 1, 2018
Phase: N/A
Study type: Interventional

The goal of this translational study is to establish a newly emerging CT-based tool for the characterization of changes in bone micro-architecture and assessment of their implications for fracture-risk in a population of COPD patients at risk for osteoporosis. The tool will be suitable and generalizable across emerging CT scanners from different vendors, and it will provide a more structurally-based assessment of osteoporosis and bone loss than is provided by simple bone density measures. The study will characterize the impact of different COPD-related factors on bone structure, and their implications for fracture-risk, leading to the development of a COPD-specific model for assessment of fracture-risk that will utilize patient-specific demographic, clinical and radiographic data, and CT BMD at the spine, as well as bone structural measures at the wrist and/or ankle.

NCT ID: NCT03518268 Not yet recruiting - Breast Cancer Clinical Trials

Vivomixx for Prevention of Bone Loss in Women With Breast Cancer Treated With an Aromatase Inhibitor

Start date: October 2018
Phase: Phase 1/Phase 2
Study type: Interventional

This study evaluates the efficacy of the probiotic food supplement Vivomixx in the prevention of bone loss occurring in post menopausal women with breast cancer treated with an aromatase inhibitor. Half of the participants will receive Vivomixx while the other half will receive a placebo. The primary endpoint is to assess changes of bone turnover markers during the period of 6 months.