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Osteoporosis clinical trials

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NCT ID: NCT01945788 Active, not recruiting - Clinical trials for Postmenopausal Osteoporosis With Pathological Fracture

Clinical Comparison of Efficacy and Safety of Two Teriparatide Formulations: Osteofortil and Forteo

Start date: June 2013
Phase: Phase 4
Study type: Interventional

The primary objective of this study is to compare efficacy and safety of two formulations of teriparatide 20 mcg/day plus calcium and vitamin D in postmenopausal women with osteoporosis.

NCT ID: NCT01745068 Active, not recruiting - Clinical trials for Osteoporosis With Current Fragility Fracture

Partnership for Applied Research in Fracture Prevention Programs for the Elderly

OPTI-FRAC
Start date: January 2013
Phase: N/A
Study type: Interventional

During their lifetime, approximately 50% of Canadian women and 30% of Canadian men will experience at least one fracture due to bone fragility (FF). Evidence is growing regarding prevention programs' effectiveness to prevent falls, but prevention of fractures through fall prevention programs has enjoyed limited success. Falls prevention programs and post-fracture screening programs leading to pharmacological treatment are very different strategies, with a shared ultimate goal. Coordination between those who repair fractures and those who manage the patient to prevent the next fracture is critical. The overarching aim of this proposal is to generate evidence-based knowledge about the effectiveness and cost-effectiveness of an integrated FF prevention program, as well as a portrait of the barriers and facilitating factors for such programs. More specifically, the objectives are: 1) to combine existing fall prevention and post-fracture management programs in the province of Quebec into integrated FF prevention programs; 2) to compare the performance of these integrated programs to control sites, using a pragmatic study design; 3) to identify barriers as well as factors that improve effectiveness across different implementation milieu; and 4) to develop and engage in active knowledge transfer activities in Quebec regions where integrated FF prevention programs are neither adequately nor successfully implemented. Drawing upon the literature on integrated healthcare, fall and fracture prevention, we hypothesize that an integrated FF program can reduce the risk of a subsequent fracture by at least 30% in the population of interest. The proposed team is poised to develop new interdisciplinary collaborations among healthcare practitioners and decision makers involved in the prevention of FFs. The program is built upon existing healthcare and structures and programs and in turn, will truly measure the effectiveness of an integrated FF prevention program. The results will ultimately lead to improvements in the existing knowledge base, address policy-relevant and health systems problems, and assist in the design and implementation of FFs prevention programs.

NCT ID: NCT01604057 Active, not recruiting - Osteoporosis Clinical Trials

Study to Evaluate Effect of Intranasal Teriparatide on Serum P1NP, a Biomarker of Bone Formation, in Postmenopausal Women With Low Bone Mass

Start date: November 2011
Phase: Phase 2
Study type: Interventional

This study is being conducted to evaluate the effect treatment has on serum P1NP levels, a biomarker of bone formation in postmenopausal women with low bone mass.

NCT ID: NCT01417598 Active, not recruiting - Osteoporosis Clinical Trials

BETA Study: Improving Balance Function in Elderly by Progressive and Specific Training and Physical Activity

BETA
Start date: January 2010
Phase: N/A
Study type: Interventional

Balance control, physical activity and health related quality of life will be assessed before and after a 10 to 12 weeks training program as well as 6 and 12 months thereafter in 200 elderly (>60) with balance problems (100 with osteoporosis, 100 with Parkinson's disease). Osteoporosis subjects will be assigned to 3 groups (balance training, balance training and Nordic walking, or control group) and Parkinson's subjects to 2 groups (balance training or a control group). The training will be progressive and specific incorporating dual task exercises (directly related to an increased risk of falling). Clinical and laboratory gait and balance measures as well as questionnaires will be used to assess physical function and quality of life. An earlier study, investigating this training program in healthy elderly with balance problems showed that the training was well-tolerated and effective, with a significant increase in balance control, physical function and activity. In this study, we expect that an improvement in balance function, physical activity and health related quality of life, which will lead to a decreased number of falls, prevent and/or postpone incidence of a hazardous fall and thereby reduce the burden on the health care system. Our model for functional balance training and outcome methods will expand techniques and tools available to physical therapists and health care scientist treating and evaluating patients with loss of balance function. Elderly receiving therapy with the goal to improve or recuperate physical function and balance will benefit from this project.

NCT ID: NCT01377467 Active, not recruiting - Osteoporosis Clinical Trials

Denosumab for Prevention of Osteoporosis in Renal Transplant Recipients

POSTOP
Start date: June 2011
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to examine the effect of denosumab on lumbar spine bone mineral density (BMD) after one year of treatment in newly transplanted renal allograft recipients. Secondary endpoints include BMD changes at the total hip and the femoral neck, changes in body height, changes in bone mineral metabolism parameters, incidence of fractures, and allograft function at one year. Safety measurements include the occurrence of rejection episodes, infectious complications, graft loss and mortality. - Trial with medicinal product

NCT ID: NCT01374412 Active, not recruiting - Multiple Myeloma Clinical Trials

Investigation of Bone Defects and Microcirculation With Computed Tomography and Magnetic Resonance Imaging

Start date: July 2010
Phase:
Study type: Observational

Subject of the proposed study is the non-invasive in vivo imaging of bone, bone marrow and localized microcirculation in test animals with osteoporosis, fractures and after placement of bone substitute material with volume computed tomography (VCT) (animals only) and functional magnetic resonance imaging (MRI). In vivo imaging by means of functional MRI and VCT is carried out in osteoporotic rats, both after the induction of fracture as well as after the placement of bone substitute material. Furthermore, patients with asymptomatic MM are investigated with functional MR-Imaging (Dynamic Contrast Enhancement- MRI and Intravoxel incoherent motion (IVIM)-imaging) longitudinally to predict the occurrence of osteolysis and the time to progression regarding SLIM-CRAB-Criteria (Rajkumar et al., Lancet Oncology, 2014). Hypothesis: 1. Affection of microcirculation at the junction of bone and bone substitute material can be displayed by VCT and functional MRI 2. Functional MRI has prognostic value regarding occurrence of osteolysis and progression to MM regarding SLIM-CRAB-Criteria

NCT ID: NCT01232647 Active, not recruiting - Clinical trials for Post-menopausal Osteoporosis

Vitamin K as Additive Treatment in Osteoporosis

VITKANDOP
Start date: April 2015
Phase: Phase 2/Phase 3
Study type: Interventional

Vitamin K is thought to be important for bone health because it activates several proteins involved in bone formation. Poor dietary intake of vitamin K (mainly found in dark green leafy vegetables) is associated with bone loss and fractures. Giving supplements of the main dietary form of vitamin K (called K1) or another common form which our bodies make from K1(called MK4), to improve bone health have given mixed results. This confusion is thought to have arisen because these studies involved people who already had enough vitamin K or did not have osteoporosis. We want to test the hypothesis that treatment with bisphosphonates combined with vitamin K, in vitamin K deplete elderly women with osteoporosis, may offer additional benefit on skeletal metabolism and reduction of fracture risk. We want to test this by measuring vitamin K status in post-menopausal women with osteoporosis who are on the recommended treatment with a bisphosphonate and calcium/vitamin D supplements. Those with low vitamin K will then be recruited to study the effect of supplementation with either K1 or MK4.

NCT ID: NCT01206491 Active, not recruiting - Osteoporosis Clinical Trials

Development of Intervention Model for Osteoporosis and Fall Prevention in Taiwan

Start date: September 2010
Phase: N/A
Study type: Observational

Department of Chronic Disease and Health Promotion of World Health Organization listed eight classes of chronic disease which will be important globally in the future. And the sixth class is "Chronic Rheumatic Condition", which includes rheumatic arthritis, osteoarthritis, osteoporosis, spinal disorders and severe limb trauma. Obviously the osteoporosis is a globally important health topic. Osteoporosis draws more and more attention, because osteoporosis has various influences, for example, (1) psychologically impact which occurs frequently in many chronic diseases, such as depression will appear evidently in patients with osteoporosis (2) patients with osteoporosis often lose their social role (3) osteoporosis might induce pain and limitation of body function (4) osteoporosis increases greatly the possibility of fracture. Osteoporosis will induce adverse outcomes, such as the fall of life quality, the increase of morbidity and mortality, as well as the increased abuse of medical service. In this project, the investigators will set up the intervention model for prevention of osteoporosis as well as falls. In this project, the investigators will recruit patients form outpatient services at WanFang Hospital. Through the collection of baseline data from questionnaire and bone density measurement, the investigators can clarify the risk of osteoporosis and falls in studied patients. By using double-blind randomized design, the patients will be collected to either one of intervention and control group. After eight weeks of intervention programs, the investigators will follow on both groups to understand the effect of this program and to increase the bone density of intervention group. The hospital or the Health center might take the outcome to be the reference of taking care the Osteoporosis.

NCT ID: NCT01155245 Active, not recruiting - Osteoporosis Clinical Trials

Teriparatide (PTH) and Bone Strength in Postmenopausal Women

Start date: June 2008
Phase:
Study type: Observational

This study will investigate the effects on bone quality of a medication (Teriparatide) used to treat people with severe osteoporosis. Teriparatide is the only bone formation therapy that has been approved for the treatment of postmenopausal osteoporosis in Canada. Osteoporosis is currently diagnosed using a bone mineral density (BMD) scan, which measures the amount of mineral (calcium etc) in bones (the higher the amount of mineral, the lower the fracture risk). Although BMD is linked to bone strength and is used to measure fracture risk, it does not give information on bone structure (called bone geometry) which can also tell us a great deal about fracture risks. Clinical trials have shown that teriparatide increases BMD at the lumbar spine and total hip, while BMD at the forearm decreases after 20 months of therapy. Whether this decrease of BMD at the forearm suggests a higher risk of wrist fracture or a change in bone structure is unclear. Bone biopsies of the pelvis done on people taking teriparatide shows improvement of bone geometry (ie bone thickness and increased trabeculae (small interconnecting rods of bone), suggesting that a change in bone geometry at the wrist may be occurring as well. Currently, there is a new technology, high resolution pQCT (HR-pQCT) that can assess bone geometry without a biopsy. Since bone strength is affected both by BMD and bone structure (as well as other material properties), our group is interested in examining changes in bone geometry at the forearm (a non-weight bearing site) and ankle (a weight bearing site) in postmenopausal women with osteoporosis who receive 24 months of teriparatide therapy. The investigators believe that this new approach of measuring bone strength will help us better understand whether teriparatide has different effects at different bone sites.

NCT ID: NCT01105923 Active, not recruiting - Breast Cancer Clinical Trials

Study of an Intervention to Improve Problem List Accuracy and Use

MAPLE
Start date: May 2010
Phase: N/A
Study type: Interventional

The aim of this study is to identify patients with problem list gaps and intervene to correct these gaps by creating clinical decision support interventions that alert providers to likely problem list gaps and offer clinicians the opportunity to correct them. The investigators will randomize the clinics that will receive the intervention and formally evaluate the study after a period of 6 months for improved problem list completeness to determine the effectiveness of our intervention.