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Osteoporosis clinical trials

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NCT ID: NCT03367585 Recruiting - Clinical trials for Osteoporosis, Postmenopausal

Vitamin D Supplementation Effects on the Training Muscle Strength and Balance

Start date: February 2018
Phase: N/A
Study type: Interventional

Introduction: In Brazil, the person who is sixty years or more is considered elderly. The country points to an age structure increasingly aging, implying adjustments of policies, especially health, to serve this population. A vitamin D deficiency can cause atrophy muscular of type II fibers (fast twitch and strength), which can increase the risk of falls. The aging process produces reduction in the ability of postural control system to maintain balance, which may increase postural instability and consequently take the elderly to falls. Purpose: To evaluate whether vitamin D supplementation associated with regular exercise in vulnerable older women improves muscle strength and postural balance in 12 weeks. Methods: This will be a randomized prospective clinical trial, double-blind, placebo-controlled intervention. Will be part of the study 40 elderly women vulnerable, who meet the inclusion criteria and that will be coming from the community through calls made by radio. The volunteer will take blood, bone densitometry, functional capacity test, strength assessment and postural balance before and after 12 weeks of intervention with vitamin D supplementation and resistance and postural balance exercise.

NCT ID: NCT03337971 Recruiting - Clinical trials for Osteoporosis, Postmenopausal

Nutritional Supplement and Bone Health in Post-Menopausal Women

Start date: October 3, 2017
Phase: N/A
Study type: Interventional

The process of bone remodeling exhibits pronounced diurnal pattern that is important for bone health. A balanced rate of bone resorption is required to maintain bone health, a balance that can be disturbed during the lifecycle to effect net rate of formation (as occurs during growth and development to adulthood) or net resorption (as occurs, for example, during the menopause).The research to be undertaken investigates the pluripotent effect of dairy-based products on the regulation of the diurnal process of bone metabolism in post-menopausal women at risk of osteoporosis.

NCT ID: NCT03328650 Recruiting - Clinical trials for Proximal Humeral Fracture

Clinical Outcomes of the ALPS Proximal Humerus Plating System

Start date: August 7, 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to document the performance and clinical outcomes of the A.L.P.S® Proximal Humerus Plating System. The optional, interventional arm of this study will assess bone quality in the proximal humerus of a fracture patient population. Specific Aims: - Conduct physical assessments measuring shoulder strength and range of motion, physician assessment of radiographs - Obtain patient-reported outcomes regarding pain level, function capabilities, and work/leisure restrictions - Document revisions, complications, and adverse events The optional, interventional arm of this study will assess bone quality in the proximal humerus of a fracture patient population. DXA is not particularly effective at identifying individuals who are at risk of suffering a fracture. Yet, there is a growing population of diabetics and elderly individuals prone to fragility fractures. In effect, the age-related and diabetes-related increase in fracture risk is independent of a person's aBMD. These findings stress the urgency in developing diagnostic tools that can improve fracture risk prediction so that patients can be treated with the appropriate anti-fracture therapies. Shifting from the current paradigm of using X-ray based modalities to assess fracture risk, the reference point indentation (RPI) method acquires direct measurements of 'materal quality' of the bone tissue. Specifically, the OsteoProbe-RPI engages the patient's bone, and upon applying an impact force, it measures the ability of the tissue to resist micro-indentation. Despite the encouraging results from aformentioned studies applying RPI to bone, there is no evidence that a local measurement of bone material quality are predictive of fracture resistance at sites that are prone to fragility fractures (e.g. the proximal humerus). By affirming the ability of RPI to discriminate a fragility fracture from a high-energy (trauma) fracture of otherwise normal bone, the data from this optional study arm may provide justification for large prospective studies that evaluate whether intra-operative RPI is useful for surgical guidance.

NCT ID: NCT03293108 Recruiting - Osteoporosis Clinical Trials

Comparing Efficacy and Safety of AryoGen Pharmed Biosimilar Denosumab 60 mg (Dyenix) Versus Prolia® in Improvement of Bone Mineral Densitometry (BMD) Among Osteoporotic Postmenopausal Women

Start date: April 29, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy and safety of Denosumab 60 mg produced by AryoGen Pharmed and Amgen Denosumab 60 mg among osteoporotic postmenopausal women. Postmenopausal women diagnosed with osteoporosis according to their Bone mineral density result (BMD), aged between 45 to 75 are included in this trial. This is a Phase III, randomized, two armed, double-blind, parallel, active-controlled,non-inferiority clinical trial. The eligible patients are randomized in a 1:1 ratio to receive Dyenix or Prolia® subcutaneous injections, at the beginning of the trial and every 6 months at month 6 and 12, in an 18-month study period. Along with, all women will receive daily supplements containing at least 1000 mg of elemental calcium (divided into two doses) and at least 400 IU vitamin D daily during 18 months of the study. The primary objective of this study is to assess non-inferiority of test- Denosumab 60 mg (Dyenix) to the reference Denosumab 60 mg (Prolia®) in terms of efficacy among osteoporotic postmenopausal women. The secondary objectives of this study are: To further compare efficacy of test- Denosumab 60 mg to reference Denosumab 60 mg; To assess the safety of test- Denosumab 60 mg compared to reference Denosumab 60 mg.

NCT ID: NCT03251430 Recruiting - Osteoporosis Clinical Trials

Bone Microstructure by Using HR-pQCT in Long Courses After Gastrectomy

Start date: August 20, 2017
Phase: N/A
Study type: Observational [Patient Registry]

Osteoporosis after gastrectomy, which is characterized by both the loss of bone mass and the deterioration of bone architecture, is a serious complication in the long course after gastrectomy. The aim of the present study was to evaluate osteoporosis by using high-resolution peripheral quantitative computed tomography (HR-pQCT) in the long course after gastrectomy. In total gastrectomy and distal gastrectomy groups, at least 5 years should have elapsed since gastrectomy.

NCT ID: NCT03225703 Recruiting - Clinical trials for Osteoarthritis, Knee

The Effect of High Impact Exercise on Bone and Articular Cartilage in Post-menopausal Women

Start date: January 2017
Phase: N/A
Study type: Interventional

Osteoarthritis (OA) and osteoporosis (OP) affect large numbers of the population. Around 8 million people in the UK are affected by OA and over 300,000 people present with fragility fractures in the UK each year. High impact exercise has been shown to improve markers of bone health but the effect of this exercise on the cartilage is less well understood. A six month, one leg, exercise program based on hopping will be carried out by a group of post-menopausal women. Post-menopausal women are particularly at risk from OP and the research should give information on the feasibility of this type of exercise program in this age group and the effect on cartilage. Participants will be aged between 55 and 70 (at least five years post menopause) with no conditions that would limit their ability to complete the exercise program. To assess changes in participants' cartilage and bone properties they will be asked to attend several meetings at Loughborough University. Before and after the exercise program participants will have bone density scans and MRI scans of the knee joint. A subset (n=4) will undergo high resolution bone scans that can demonstrate changes in bone structure. The intervention is a home based exercise programme lasting approximately 10 minutes per day. Initially this will be individualised to each participant with the end goal being daily exercise sessions. The programme will last for six months with supervised sessions offered throughout the trial. Using an intervention affecting just one leg will allow the research team to use the other leg as a control. The research team hypothesise that in a population of post-menopausal women, a six month, unilateral exercise intervention will improve bone mineral density at the proximal femur with no negative effects on articular cartilage.

NCT ID: NCT03225040 Recruiting - Acromegaly Clinical Trials

Bone MicroArchitecture in Acromegaly

Start date: August 3, 2016
Phase: N/A
Study type: Observational

The investigators will conduct a cross-sectional study of bone density, bone microarchitecture, vertebral fractures and trabecular bone score in 25 patients with acromegaly treated with Pegvisomant, the growth hormone (GH) receptor antagonist for at least 1 year and with normal insulin-like growth factor-1 (IGF-1) levels. This study aims to describe the bone architecture and associated biochemical indices of bone turnover and metabolism in patients with active acromegaly and how these are altered with treatment of the disease.

NCT ID: NCT03201016 Recruiting - Osteoporosis Clinical Trials

Prevalence of Osteoporosis and Fractures in Patients With Hepatic Cirrhosis and Investigation of the Associated Factors

Start date: June 2016
Phase: N/A
Study type: Observational [Patient Registry]

Osteoporosis is a common complication in chronic liver disease, especially in the late stages of the disease. Good nutrition and calcium and vitamin D supplementation are recommended for the prevention and treatment of osteoporosis. There are no specific guidelines for its pharmacological treatment, but bisphosphonates have been shown to be effective in increasing bone mass in patients with chronic cholestasis, with a good safety profile. There are few studies evaluating the prevalence of osteoporosis in patients with cirrhosis (except for primary biliary cholangitis (PBC)). There are no clear recommendations for osteoporosis screening in cirrhotic patients. A diagnosis and early therapeutic intervention before the onset of the complications derived would significantly improve the quality of life and decrease the morbidity and mortality associated with osteoporosis and fractures Objective: -To assess the prevalence of osteoporosis and fragility fractures in patients with liver cirrhosis in our country and the risk factors associated Method: Patients diagnosed with hepatic cirrhosis, other than PBC, will be included in any Child stage during a hospital admission. Epidemiological, demographic, clinical, analytical and imaging data (dorso-lumbar spine radiography, bone densitometry and Trabecular Bone Score) will be evaluated. A descriptive statistic of the main variables will be carried out as well as a multivariate analysis to evaluate the predictive factors of osteoporosis and / or fragility fractures

NCT ID: NCT03197623 Recruiting - Osteoporosis Clinical Trials

Safety and Tolerability of Intravenous LLP2A-Alendronate for Osteopenia Secondary to Glucocorticoids

Start date: October 14, 2016
Phase: Phase 1
Study type: Interventional

A Phase 1 Randomized, Double-Blind, Placebo-Controlled Single and Multiple Ascending Dose Study of the Safety and Tolerability of Intravenous LLP2A-Alendronate in Adult Men and Women with Osteopenia Secondary to Corticosteroids.

NCT ID: NCT03197545 Recruiting - Stress Fracture Clinical Trials

Determining the Risk of Stress Fracture in IDF Soldiers Based on SNPs Identified for Osteoporosis

Start date: June 2017
Phase: N/A
Study type: Observational

The study is a genetic historical cohort study in a military combat recruits - this study does not examine a specific treatment but rather examines a statistical link between medical history of traumatic fractures, clinical diagnosis of stress fractures and the presence of unique SNPs in subjects DNA.