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Osteoporotic Fractures clinical trials

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NCT ID: NCT02148848 Recruiting - Clinical trials for Osteoporotic Fractures

Short-term Functional Recovery Between Early- and Late Bisphosphonate Treatment Following Hemiarthroplasty

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

Femoral neck fracture in the elderly is one indication for initiating osteoporosis treatment. Bisphosphonates remain the first line therapy; however, many orthopaedic surgeons concern regarding their effects on fracture healing process. Therefore, therapy is usually delayed for a period of time. To the best of our knowledge, there is no scientific data to support whether bisphosphonate treatment should be given immediately after the surgery or it should be delayed.

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: NCT01839682 Completed - Osteoporosis Clinical Trials

Evaluation of Outcomes of DFine StabiliT Kyphoplasty in Vertebral Compression Fractures Due to Osteoporosis

Start date: June 2009
Phase: N/A
Study type: Observational

This post-market surveillance research project consists of data collection at specified time points using standard questionnaire instruments to compare pain level, mobility and function pre and post procedure using the D-Fine StabiliT® Vertebral Augmentation System and StabiliT® Bone Cement, an FDA approved product used in the standard treatment of vertebral compression fractures.

NCT ID: NCT01780012 Completed - Clinical trials for Osteoporosis With Current Fragility Fracture

Evaluation of an Osteoporosis Prevention Strategy in Women With Osteoporotic Fracture of the Upper Limb

PREVOST
Start date: March 2012
Phase: N/A
Study type: Interventional

Osteoporosis is a disease characterized by reduced bone mass and increased skeletal fragility, predisposing to an increased fracture risk. The presence of a low trauma fracture is a powerful predictor of future fractures and about 50% of patients with a fragility fracture will suffer a subsequent fracture in the next 10 years (Center Jacqueline R, 2007). Osteoporotic fractures are associated with an increased morbidity and mortality but also high financial costs. However, less than 20% of patients presenting a low trauma fracture receive an appropriate post-fracture osteoporosis management (Little and Eccles, 2010). The hypothesis of a lack of information and an under assessment of consequences by both patients and physicians has been raised to explain this gap between recommended care and usual practices. The aim of the PREVOST program is to assess the efficiency of patient-centered osteoporosis prevention program, after a fragility fracture of the upper limb, to improve post-fracture management of osteoporosis (ie BMD test and / or osteoporosis treatment) in women over 50 years old. This open randomized controlled trial aims to compare the BMD or osteoporosis treatment prescription rate at 6 months after inclusion between two groups: "intervention" receiving information on fracture and osteoporosis (oral and written), phone call reminders and written information to give to their family physician, and "control" receiving usual care without information.

NCT ID: NCT01761084 Completed - Clinical trials for Osteoporotic Fractures

Build Better Bones With Exercise

B3E
Start date: January 2013
Phase: N/A
Study type: Interventional

The long-term goal of our research team is to conduct a large multicentre study to evaluate whether tailored home exercise can prevent fractures in high-risk individuals. The proposed project will address the feasibility of such a trial, but will also evaluate the effect of exercise on quality of life, posture and many other outcomes important to individuals with vertebral fractures. Physiotherapists will conduct 6 home visits with participants to deliver the intervention (or social visit for controls) using a similar model to previous work by our team and others. The purpose of this pilot study is determining the feasibility of recruitment, retention and adherence of an international multicentre randomized controlled study evaluating the efficacy of thrice-weekly home exercise for one year among women with vertebral fracture. As secondary objectives, the investigators will examine the effects of exercise on function, balance, quality of life, pain, falls and fractures. The primary hypothesis is that the investigators will successfully recruit and retain the target sample, and achieve an adherence rate of 60%.

NCT ID: NCT01537770 Completed - Clinical trials for Osteoporotic Fractures

Vertebroplasty Compared With a Sham-procedure for Painful Acute Osteoporotic Vertebral Fractures

VOPE
Start date: February 2012
Phase: Phase 4
Study type: Interventional

The main purpose of this study: - to determine whether vertebroplasty has a pain palliating effect superior to a sham-procedure for acute painful osteoporotic vertebral fractures of the thoracic and lumbar spine. Secondary purposes: - To determine if there are differences in the two methods on preventing forward tilting of the spine and/or shortening of the total height of the spine. - measure if there are differences in change of lung capacity between the two methods

NCT ID: NCT01532076 Terminated - Clinical trials for Osteoporotic Fractures

Effectiveness of Adipose Tissue Derived Mesenchymal Stem Cells as Osteogenic Component in Composite Grafts

ROBUST
Start date: June 2012
Phase: Phase 2
Study type: Interventional

Failure rates of up to 30% are reported after proximal humeral fractures despite angular-stable devices. This may devastate not only the functional outcome but also the independence of elderly patients. To increase bone mineral density and thereby holding-strength augmentation is an option. Autologous bone-graft, as current gold-standard, though is questionable in osteoporosis since osteoprogenitors are dysfunctional and the harvesting-morbidity considerable. Adipose tissue seems an alternative cell-source even in presence of osteoporosis. Stromal vascular fraction (SVF) cells isolated from lipoaspirates display osteogenic and vasculogenic potential and can be harvested in high numbers. Expansion associated with costly good-manufacturers-practice facilities is avoidable, so are repeated interventions. These cells have been successfully used to generate osteogenic composite grafts with intrinsic vascularity in preclinical models. For translation into clinical practice after a 20 patient external pilot a prospective randomized controlled trial with 270 patients is planned. For the trial lipoaspiration precedes open reduction and internal fixation in individuals over 60 years presenting with a proximal humeral fracture after low-energy trauma. Cells are isolated (Cellution®800/CRS) and wrapped around hydroxyapatite microgranules after embedding in a fibrin-gel for augmentation of the typical bone-void. Clinical/radiological follow-up is at 6 and 12 weeks for immediate complications and after 6, 9 and 12 months. Functional assessment is performed after 6 weeks, 6 and 12 months using the Quick-Dash- and Constant-Score. The primary outcome is a reduction in secondary dislocation by 50% during the first postoperative year. Secondary dislocation is diagnosed on plain radiographs by an independent board certified radiologist specialised in musculoskeletal imaging if one or more of the following criteria are met: - More than 20° varus collapse of the humeral head fragment in relation to the humeral shaft - Screw penetration through the humeral head

NCT ID: NCT01482793 Completed - Clinical trials for Vertebral Compression Fractures

A Controlled Trial of Vertebroplasty for Acute Painful Osteoporotic Fractures

Start date: November 2011
Phase: N/A
Study type: Interventional

The objective of this study is to gather data regarding the efficacy, safety and cost-effectiveness of percutaneous vertebroplasty in the acute fracture group with fractures less than 6 weeks old. The AVAMAX vertebroplasty kits (Care Fusion) will be used for all vertebroplasties. The primary effectiveness analysis will be based on the number of patients whose numeric rating pain score drops from above 7 out of 10 at baseline to below 4 out of 10 at two weeks post-intervention. Our hypothesis is that the vertebroplasty group will have a significantly larger proportion of patients achieving pain reduction than the control group. A secondary analysis will compare the change in mean pain scores and specific activity related pain scores between the two groups at 3 days, 14 days and at 1, 3 and 6 months. Another secondary effectiveness analysis will include the mean change in the back-pain specific limitation in function as quantified by the Roland Scale at these same data collection time points.

NCT ID: NCT00639210 Completed - Clinical trials for Improve Quality of Life

BREAST CANCER AND EXERCISE

BREX
Start date: September 2005
Phase: Phase 3
Study type: Interventional

A Finnish Breast Cancer Group Study (BREX 01-2004). A multicenter phase III open randomised trial of the efficacy of exercise in the prevention of long-term adverse effects of adjuvant treatments and breast cancer recurrences in women with primary breast cancer. The aim of the study is to investigate whether regular exercise training could reduce the long-term side effects of adjuvant treatments of primary breast cancer and improve quality of life and well being.

NCT ID: NCT00594295 Completed - Clinical trials for Osteoporotic Fractures

Follow-up of Bone Quality in Long-Term Bone Marrow Transplant Survivors

Start date: June 2007
Phase: N/A
Study type: Observational

Brittle and broken bones can occur after organ transplantation. However, the long-term effects of bone marrow transplantation on bone health and the risk of breaking bones are not well understood. This study will help to assess how common it is for those who have received a bone marrow transplant to have fractures. It will also investigate blood tests related to bone health. This will be done by measuring bone mineral density and obtaining blood tests.