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Bone Diseases clinical trials

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NCT ID: NCT01740115 Completed - HIV Infection Clinical Trials

Boston Alcohol Research Collaboration on HIV/AIDS (ARCH) Cohort

Start date: November 2012
Phase: N/A
Study type: Observational

The purpose of this study is to expand and continue a cohort of HIV-infected adults to establish the longitudinal Boston ARCH Cohort of 250 HIV-infected men and women with current substance dependence or ever injection drug use that have a spectrum of alcohol use; and to determine the effect of alcohol consumption on changes in bone health prospectively in the Cohort.

NCT ID: NCT01734824 Suspended - Quality of Life Clinical Trials

Treatment of Atraumatic Bone Marrow Edema With Denosumab and Teriparatide vs Placebo

Start date: May 2012
Phase: Phase 4
Study type: Interventional

The etiology of bone marrow edema (BME) is still uncertain. Several studies report therapeutic success with antiresorptive drugs. This study investigates antiresorptive and osteoanabolic drugs versus placebo in BME

NCT ID: NCT01725113 Terminated - Kidney Failure Clinical Trials

Management of Mineral and Bone Disease in Hemodialysis-Calcitriol vs. Paricalcitol

ECRIP
Start date: November 2012
Phase: Phase 4
Study type: Interventional

The purpose of this non-inferiority study is to compare the safety and effectiveness of a mineral and bone disease treatment protocol based on calcitriol to one based on paricalcitol in hemodialysis patients using revised Kidney Disease: Improving Global Outcomes (KDIGO) parathyroid hormone targets.

NCT ID: NCT01690260 Completed - Osteoarthritis Clinical Trials

Parallel Study Between BMP-2 and Autologous Bone Graft After Ilizarow Treatment

Start date: September 2004
Phase: Phase 1
Study type: Interventional

Results of growth factors indicate that Bone Morphogenetic Proteins (BMP) have an exceptional ability to stimulate different characteristics of mesenchymale cells to osseous cells. Local application of BMP results in an increase of osseous tissue regardless of the location of the growth factor. 5 years clinical studies show that BMP's can stimulate an increase of osseous tissue and improve clinical results when autologous bone graft is reduced or removed. The purpose of this study is to examine whether recombinant growth factor BMP-2 can replace autologous bone graft in order to stimulating ossification during transplantation of osseous tissue.

NCT ID: NCT01633619 Not yet recruiting - Bone Diseases Clinical Trials

European Implant Cohort Study

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

The incidence of postoperative PJI is ranging from 0.5-2.5% for primary interventions and are reported up to 20% for revision procedure. In addition, hematogenous PJI can occur at any time after implantation and the risk of infection remains during the entire prosthesis indwelling time. Prosthetic joint infections (PJI) are associated with significant morbidity and costs to the healthcare system. Evidence for optimal management of PJI with best outcome and lowest expenses is limited and recommendations between countries vary significantly. There is unmet need to standardized diagnostic procedures and definition of infection as well as achieve a consensus for uniform treatment guidelines.The European Implant Cohort Study (EICS) is a multicenter European research project, including patients with PJI in a cohort representative for Europe. The EICS is established jointly by the Orthopedic and Traumatology surgeons, Infectious Diseases specialists and microbiologists of selected university and non-university institutions across Europe. The principal aim of the EICS is to improve the management of PJI and develop consensus guidelines across Europe. By systematic analysis of consecutively included patients with PJI, factors associated with best outcome regarding infection (assessed by the infection-free interval) and joint function (assessed by the degree of pain, mobility, range of motion) will be determined in a longitudinal prospective study with long-term follow-up. This is an investigator-initiated, open, prospective, multicenter observational study. Participating study centers will be university or non-university hospitals across Europe, which fulfill the following study conditions: - Close collaboration between infectious diseases specialists, microbiologists and orthopedic/trauma surgeons, - Availability of appropriate microbiological methods (following standard recommendations including sonication of removed prosthesis), - Availability a dedicated study team (study nurse and/or research fellow) for regular eligibility screenings, patient inclusion procedure, real-time data collection and patient follow-up. This project may generate important scientific evidence for future guidelines regarding management of PJI, has the potential to initiate new multicenter substudies in an establish network, and may open further collaboration and exchange of skills between institutions across Europe.

NCT ID: NCT01630629 Completed - Lactation Clinical Trials

Longitudinal Lactation Bone Density Study

Start date: August 2012
Phase: N/A
Study type: Observational

Changes in maternal calcium metabolism are necessary during lactation to provide adequate calcium in breast milk for development of the newborn skeleton. The calcium in milk is derived from the maternal skeleton, resulting in significant bone loss, a process thought to be mediated by the actions of parathyroid hormone-related protein (PTHrP) in combination with a decreased estrogen levels. After weaning, bone lost during lactation is rapidly regained. Differences between African-American and Caucasian bone metabolism are well documented and include higher bone mineral density (BMD), lower risk of fragility fracture, lower 25-hydroxyvitamin D (25(OH) D), and higher PTH in African-Americans compared to Caucasians. Most studies of bone metabolism in lactating women have been done in Caucasians. Because of differences in bone metabolism between African-Americans and Caucasians, we do not know whether African-Americans will have similar findings. The primary aim of this study is to compare the changes in bone mineral density (BMD) during lactation in African-Americans with those in Caucasians. It is not known whether the loss in BMD during lactation will be the same for both races. African-Americans display skeletal resistance to PTH with short-term infusions and have lower bone resorption, higher BMD and lower fracture risk than Caucasians. A recent study by our group indicated that lactating African-American mothers had slightly lower bone resorption but quantitatively similar bone formation compared to Caucasians. However, there was a significant increase of 2-3 fold in markers of bone formation and resorption in both groups. Therefore, it is currently not known whether the loss in BMD during lactation will be the same for both races. Primary outcome measures in this study will include spine, hip and radius BMD by Dual X-Ray Absorbiometry (DXA)Scans during lactation (at 2,12 and 24 weeks postpartum or at weaning if prior to 24 weeks postpartum, and six months after weaning (+1 week). This longitudinal protocol will distinguish between two hypotheses. Either: a) as measured by BMD, bone loss in African-Americans during lactation will be equal to that in Caucasians, and skeletal recovery will be the same or possibly accelerated compared to Caucasians; or, b) African-Americans will be resistant to bone loss during lactation compared to Caucasians because of resistance to Parathyroid Hormone-related Protein (PTHrP).

NCT ID: NCT01612299 Withdrawn - Renal Transplant Clinical Trials

Effects of Zortress® + Tacrolimus vs. Standard Immunosuppression on Progression of Coronary Artery Calcifications and Bone Disease in de Novo Renal Transplant Recipients

Start date: May 2012
Phase: N/A
Study type: Interventional

Primary objectives: A. To evaluate the effect of Zortress® versus standard immunosuppression therapy on progression of CAC as evidenced by changes in Agatston scores from baseline and at 6, and 12 months in renal transplantation patients. B. To investigate progression of CAC in patients undergoing renal transplantation within the study period. Secondary objectives: 1. To evaluate in renal transplantation the effect of Zortress® versus standard immunosuppression therapy on bone mass as evidenced by changes in quantitative computed tomography (QCT) and dual energy X-ray absorptiometry (DXA). 2. To evaluate in renal transplantation the effect of Zortress® versus standard immunosuppression therapy on activity of bone forming and resorbing cells as evidenced by changes in bone histology. 3. To evaluate in renal transplantation the effect of Zortress® versus standard immunosuppression therapy on biochemical parameters of bone turnover as evidenced by changes in serum Parathyroid Hormone (PTH), Bone-Specific Alkaline Phosphatase (BSAP), Tartrate-Resistant Acid Phosphatase (TRAP), Sclerostin, Receptor Activator of Nuclear factor Kappa B Ligand (RANKL), Osteoprotegerin (OPG), , serum CTX (C-terminal telopeptide of type 1 collagen), and urinary NTX (N-terminal cross link telopeptide). 4. To evaluate in renal transplantation the effect of Zortress® versus standard immunosuppression therapy on cardiovascular events, graft rejection and patient survival.

NCT ID: NCT01603472 Completed - Clinical trials for Metabolic Bone Disease

Markers of Bone Disease in Children on Parenteral Nutrition

Start date: May 2012
Phase: N/A
Study type: Observational

Parenteral nutrition (PN) is the provision of nutrients via the intravenous route. Parenteral nutrition associated metabolic bone disease (MBD) was first described in children in the 1980s. Since then, there has been little to no research into the underlying relationship and as a result, little evidence on which to base clinical care. In adults, MBD is associated with increased fractures. At the Hospital for Sick children in Toronto, an intestinal failure program has been set up since 2003. This is the only intestinal failure program in Canada and receives country wide referrals. Most of the patients have short bowel syndrome (SBS) and require PN for prolonged periods, or for life. About 90% of these patients have MBD, and some have had bone fractures. An understanding of the etiology of MBD would provide information to guide care, and prevent this condition. Funding for this area of research however is challenging because intestinal failure requiring long term PN is a rare condition, accounting for approximately 200 - 300 children in all of Canada. The goal of this study therefore is to gather pilot data on markers of MBD in children on long term PN, and to compare these markers to age and gender matched control patients who are fed by mouth or feeding tube. The information gathered from this study will help us begin to understand what is actually happening in the bones of children on long term PN and will form the basis for future studies and improved clinical care.

NCT ID: NCT01582295 Completed - Multiple Myeloma Clinical Trials

XL184 For Relapsed/Refractory Multiple Myeloma (MM) With Bone Disease

Start date: June 2012
Phase: Phase 1
Study type: Interventional

This research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational drug. Phase I studies also try to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is still being studied and that research doctors are trying to find out more about it. It also means the FDA has not approved the drug for your type of cancer. Cabozantanib (XL184) is a new drug that is being developed to treat cancer. The study drug cabozantinib works by inhibiting several different proteins which are believed to be involved in multiple myeloma growth, its ability to spread, and its ability to form new blood vessels. This drug has been used in other research studies and information from those other research studies suggests that this drug may help to slow or stop disease growth to bones and prevent cancer growth. In this research study, we are looking to see how effective cabozantanib is in slowing or stopping disease growth to the bones as well as preventing your cancer from worsening. We are also looking for the highest dose of cabozantinib that can be given safely to patients who have multiple myeloma with bone disease.

NCT ID: NCT01571843 Completed - Clinical trials for Osteoporosis, Postmenopausal

Radius Loading in Primary Hyperparathyroidism

Start date: February 2010
Phase: N/A
Study type: Interventional

The purpose of the study is to determine the effect of forearm exercise on forearm bone density in post-menopausal women with or without primary hyperparathyroidism. The investigators hypothesize that forearm exercise will increase forearm bone density in patients with primary hyperparathyroidism more so than in patients without primary hyperparathyroidism.