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Osteoporosis clinical trials

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NCT ID: NCT03469518 Active, not recruiting - Osteoporosis Clinical Trials

Effect of β-cryptoxanthin (β-Cx), Plant Sterols and Galactooligosaccharides on Systemic and Gastrointestinal Markers

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

Regular consumption of a beverage containing β-cryptoxanthin (β-Cx) and plant sterols (PS) has been shown to exert a synergic effect in reducing some markers of cardiovascular risk and bone-remodeling (formation and resorption). The present project aims to: - Evaluate (by in vivo and in vitro studies) the bioavailability of added β-Cx, PS and galactooligosaccharides (GOS) and its stability in the beverage employed in the proposed study. - Study the biological effect (bioefficacy) associated with the regular consumption of modified milk-based fruit beverages containing β-Cx, PS and GOS in post-menopausal women (target group) by assessing changes in inflammation, cardiovascular and bone turnover biochemical markers. - Characterize genetic variability (polymorphisms), genetic expression and DNA oxidative damage in the target group as determinants of bioavailability and biological effects of β-Cx, PS and GOS. - Evaluate the potential prebiotic effect associated to regular consumption of a beverage supplemented with β-Cx, PS and GOS: including "in vitro" studies and characterization of subjects' microbiota and possible microbiota changes associated to the beverage consumption.

NCT ID: NCT03179657 Active, not recruiting - Obesity Clinical Trials

Guangzhou Nutrition and Health Study (GNHS)

GNHS
Start date: July 1, 2008
Phase: N/A
Study type: Observational

Purpose: The Guangzhou Nutrition and Health Study (GNHS) aims to assess the determinants of risk of osteoporosis and cardio-metabolic diseases and changes in their relevant indices in nutritional aspects, as well as other environmental and genetic factors. Study design: GNHS is a community-based prospective cohort study. Participants: About 4540 apparently healthy residents, living in Guangzhou city (South China) for >5 years, aged 40-80 years, recruited between 2008 and 2013. Visits and Data Collection: Participants were/will be visited every three years by invited to the School of Public Health, Sun Yat-sen University. At each visit, face-to-face interviews, specimen collection, anthropometric measurements, DXA scanning, ultrasonography evaluation were/will be conducted. Up to May 2017, 3400 and 2380 subjects completed the 2nd and 3rd visits. Key variables: 1. Questionnaire interviews: Structured questionnaires were/will be used to collect the participants' socio-demographic characteristics, lifestyle factors, menstruation and reproductive history (women only), sleep quality, family history, psychological health, social support and participation, cognitive function, habitual dietary intake, use of supplements and history of chronic diseases. 2. Physical examinations: Anthropometric measurements, blood pressure tests, handgrip strength, and usual gait speed. 3. DXA scanning: A dual-energy x-ray absorptiometry (DXA) was/will be used to determine bone density and bone mineral content, bone geometry information, fat mass and muscle mass. 4. Ultrasonography evaluations: Ultrasonography evaluation was/will be performed to determine carotid artery intima-media thickness and plaque, and fatty liver. 5. Specimen collections: Overnight fasting blood sample and early morning first-void urine sample and faces samples were/will be collected, separated and stored at −80°C till tests. 6. Laboratory tests: 1. Blood tests: Metabolic syndrome-related indices; inflammatory markers; sexual hormones and SHBG; genetic markers; nutritional indices (e.g., carotenoids; fatty acids; minerals, folate, betaine, choline, and vitamin D, etc.) 2. Urinary tests: Flavonoids and flavones; minerals; creatinine and renal function related markers 3. Fecal test: Gut microbiota and related metabolites. 7. Morbidity and mortality: Relevant data were/will be also retrieved via local multiple health information systems.

NCT ID: NCT03087851 Active, not recruiting - Osteoporosis Clinical Trials

Treatment With Zoledronic Acid Subsequent to Denosumab in Osteoporosis

ZOLARMAB
Start date: March 13, 2017
Phase: Phase 4
Study type: Interventional

Denosumab is an antibody against receptor-activator of nuclear factor kappa-B ligand that prevents recruitment and differentiation of mature osteoclasts. Treatment markedly decrease bone resorption and fracture risk, and many patients will reach osteopenic BMD levels on treatment with denosumab. The treatment effect on bone turnover and BMD has, however, been demonstrated to be reversible. This study will show if the bone mass can be maintained by administrating zoledronic acid and if timing of the first dose of zoledronic acid after last dose of denosumab matters.

NCT ID: NCT03051620 Active, not recruiting - Osteoporosis Clinical Trials

Predictive Value of Bone Turnover Markers During Discontinuation With Alendronate

PROSA
Start date: February 1, 2017
Phase: N/A
Study type: Observational

The study is a cohort study comprising 140 patients with osteoporosis stopping treatment with alendronate. The study will contribute with new knowledge about biochemical markers of bone turnover as predictors of bone loss after stopping treatment with alendronate.

NCT ID: NCT03002428 Active, not recruiting - Osteoporosis Clinical Trials

A Comparison of PF708 and Forteo in Osteoporosis Patients

Start date: December 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the effects of two teriparatide products, PF708 and Forteo, in patients with osteoporosis.

NCT ID: NCT02892188 Active, not recruiting - Osteoporosis Clinical Trials

Physician-Pharmacist Collaboration for Osteoporotic Patient Follow-up

SIOUX
Start date: January 2013
Phase: N/A
Study type: Observational

The purpose of this study is to evaluate the follow-up of the osteoporotic patient by a physician-pharmacist collaboration.

NCT ID: NCT02861989 Active, not recruiting - Osteoporosis Clinical Trials

Qualitative Study on Osteoporosis Representation and Management in the General Population and in General Practitioners.

QUALIOP
Start date: February 2014
Phase: N/A
Study type: Observational

Osteoporosis (OP) and subsequent fractures (OP fractures) are a source of morbidity and high mortality in the elderly. Despite numerous programs aiming at improving OP care, the prevention, diagnostic and treatment remain suboptimal. Barriers to a better care are multiple, both in the general and at-risk population, and in medical practitioners. Since they do not perceive their susceptibility to OP, people do not see the benefit of prevention. In addition, physicians do not give sufficient importance to OP prevention and care, despite the existence of guidelines. The investigators implemented a qualitative study to explore the knowledge and representations regarding osteoporosis in the general and at-risk population and in doctors in Rhône-Alpes Region, France, using focus groups with women and men and semi-structured face-to-face interviews with general practitioners. Understanding barriers to osteoporosis care in patients and general practitioners will help to set up effective strategies to improve prevention and treatment.

NCT ID: NCT02832648 Active, not recruiting - Osteoporosis Clinical Trials

Selenium for Musculoskeletal Health

Start date: January 2017
Phase: Phase 3
Study type: Interventional

This research aims to determine whether selenium supplements improve bone and muscle health in older women at risk of osteoporosis (low bone density or weak bones) and fracture (broken bones). Osteoporosis is a major public health problem. One in two women and one in five men over age 50 will have a fracture. Fractures cause pain, disability and reduce life-expectancy. Women with below-average bone density around the time of the menopause might have previously taken hormone replacement (HRT) to prevent osteoporosis, but HRT is much less used now due to side effects. Therefore there is a need for safe, effective and inexpensive preventative interventions for women at risk of osteoporosis. Selenium is a chemical nutrient present in several human proteins, including anti-oxidants. Anti-oxidants may protect against ageing of tissues, including bone, by mopping up damaging reactive oxygen molecules (sometimes called 'free radicals'). Selenium is present in soil, and so is obtained from many foods. However, soil selenium levels are low in Europe, and dietary intake in the UK is below recommended levels. We previously found that women with higher blood selenium levels have stronger bones, but this doesn't prove that giving selenium will improve bone strength. The investigators propose a randomised controlled trial to compare selenium supplements with a placebo (dummy treatment) in women with below-average bone density. The investigators will give selenium (at two different doses) or placebo to 120 women for six months and use blood and urine tests and bone density scans to see if giving selenium does have any effect on bone. The investigators will also do muscle function tests and measurements of free radical molecules.

NCT ID: NCT02799173 Active, not recruiting - Osteoporosis Clinical Trials

Determination of the RANKL/Osteoprotegerin Ratio in Patients With Systemic Lupus Erythematosus. Role in Osteoporosis and Cardiovascular Calcification

CALCILUP
Start date: April 2011
Phase: N/A
Study type: Interventional

Patients with Systemic lupus erythematosus (SLE) are known to present an increased risk of osteoporosis and cardiovascular calcification. It has also been suggested that bone remodelling and cardiovascular calcification are regulated by the same mechanisms, but inversely in terms of calcium deposition, as osteoporosis is often associated with cardiovascular calcification. Inflammatory and immune factors have been implicated in these two processes. The role of the RANKL/OPG system in osteoclast differentiation has been elucidated over the last ten years. RANKL induces differentiation of monocytes-macrophages into osteoclasts, while, inversely, OPG exerts an inhibitory role by inactivating RANKL. Differentiation of smooth muscle cells into osteoblasts in the vessel wall induces calcification, and this phenomenon is counterbalanced by differentiation of monocytes into osteoclasts. Although the role of the RANKL/OPG ratio in the pathogenesis of osteoporosis has now been clearly established, its role in vascular calcification is only hypothetical at the present time. This study will focus on patients with SLE diagnosed and followed in the Amiens University Hospital Internal Medicine and Nephrology departments

NCT ID: NCT02791516 Active, not recruiting - Clinical trials for Postmenopausal Osteoporosis

A Safety and Efficacy Study to Evaluate AMG 785 in South Korean Women With Osteoporosis.

Start date: January 16, 2017
Phase: Phase 3
Study type: Interventional

A multicenter, randomized, double-blind, placebo-controlled study to evaluate the effect of 6 months treatment with Romosozumab compared to placebo by determining the percent changes in bone mineral density