Short-term Supplementation, Bone Turnover and Antioxidant Status in Menopause
MenopauseNutritional Intervention1 moreThis is a 8-week, double-blinded, placebo-controlled, randomized intervention trial to investigate the effects of Mg and Zn supplementation on antioxidant status and bone hormonal parameters. Participants were randomly assigned to one of three treatment groups: Placebo group (PbG: 25 women); Magnesium Group - 500 mg/day of Mg (MgG: 27 women); Zinc Group - 50 mg/day of Zn (ZnG: 26 women).
Occlusive Skin Closure May Reduce Wound Drainage After Tumor Hip Arthroplasty
Metastatic Bone Disease of the Proximal FemurStudy Type: Investigator initiated, non-significant risk Study Objective(s): To establish the effect of occlusive wound closure with the DERMABONDTM PRINEO skin closure system, compared to routine wound closure with skin staples, on post-operative wound discharge (PWD) after tumor arthroplasty of the hip Study Population: Patients with secondary tumors of bone, undergoing tumor resection and primary endoprosthetic reconstruction involving the hip joint Inclusion Criteria: Bone resection and endoprosthetic reconstruction for metastatic bone lesions involving the proximal femur or acetabulum Imminent, or de-facto pathologic fractures of proximal femur and/or acetabulum, requiring endoprosthetic reconstruction (with or without bone resection) involving the hip joint Exclusion Criteria: Minors Pregnant and breast-feeding women Skin defects and wound conditions not amenable to primary wound closure and other DERMABOND PRINEO contraindications Underlying infection Total femur replacements Implant revision procedures Structure: Open 2-arm prospective randomized controlled trial. Duration of Study: 18 -24 months Multi-center: No Masking/Blinding: No Method of Subject Assignment: Block Randomization (10 in each block) Concurrent Control: Active - wound closure with skin staples Estimated Total Sample Size: 70 subjects will be enrolled in this study Statistical Rationale Provided: Yes Statistical Methods: Student t test for unpaired data Study Endpoints: Time to dry wound status (in post-operative days) Duration of antibiotic use (in post-operative days) Length of hospital stay (in post-operative days)
Safety and Efficacy Study of Treatment of Pathological Fractures in Humerus
Humerus Fracture Metastatic Bone DiseaseThis study will collect safety and performance data of the Photodynamic Bone Stabilization System (PBSS) when used for the treatment of fractures of the humerus secondary to metastatic cancer.
A Safety and Efficacy Study of the Treatment of Impending and Actual Pathological Fractures in the...
Humerus Pathological FractureThe purpose of this study is to collect safety and performance data of the Photodynamic Bone Stabilization System (PBSS) when used for the treatment of painful impending and actual fractures of the humerus secondary to metastatic cancer.
Vitamin D Supplementation in Diabetic Nephropathy
Sub-optimal Vitamin D StatusBone Disease1 moreDiabetes is a life-long disease that is getting more common in Canada. One of the most common problems in people with kidney disease is diabetes and low bone mineral density (BMD). This can lead to a higher chance for broken bones, infection and life-long health problems. The most common reason for having low BMD is not getting enough vitamin D (Vit D) in your diet and not having enough sunlight. This is very common in Canada (especially in northern Alberta) because winter is very long. Most people also don't eat or drink enough foods that are high in Vit D (like milk) and so they don't have enough Vit D in their body to make healthy bones. This can mean the only way to get enough Vit D in your body for your bones when you have kidney disease is to take some extra vitamin D in a pill. Most people are not aware that they have poor bone health until they break a bone. Broken bones can really hurt and can prevent a person from being able to walk and take care of themselves. Right now, we are not sure exactly how much Vit D people with diabetes and kidney disease need to take to prevent them from having low BMD or how often they need to take it. Our plan is to study the effect of two ways to take Vit D pills (every day or once a month) on overall Vit D status and on bone health in adult patients with diabetes and chronic kidney disease and see how this influences their quality of life. Hypotheses: Vitamin D supplementation (2,000 IU/day and 40,000 IU/month) for six months will result in significantly improved overall vitamin D status and improved markers of bone health in adult patients with diabetic nephropathy. Monthly dosing of vitamin D (40,000 IU/month) over six months will result in improved patient adherence and satisfaction with vitamin D supplementation when compared to daily dosing of vitamin D (2000 IU/D). This will improve vitamin D status and bone health parameters, which will result in an increased quality of life and sense of well-being.
Improving Low Bone Mass With Vibration Therapy in Adolescent Idiopathic Scoliosis (AIS)
ScoliosisBone Diseases1 moreThis is a prospective randomized controlled trial investigating the effect of vibration therapy on bone mineral density (BMD) and bone quality in AIS subjects suffering from osteopenia (low bone mass).
Cholecalciferol Supplementation for Anemia and Mineral and Bone Disorder in Hemodialysis Patients...
Kidney FailureChronic4 moreThe purpose of this study is to determine whether cholecalciferol supplementation decrease the blood concentrations of hepcidin-25 in hemodialysis patients.
A Study of Ibandronate (Bondronat) in Participants With Malignant Bone Disease
Pain; Bone Neoplasms; Neoplasm MetastasisThis study will assess the efficacy and safety of ibandronate (Bondronat), administered intravenously (IV) or orally (PO), in participants with malignant bone disease and moderate to severe pain. Participants will be randomized to receive ibandronate either as a 6-mg IV infusion every 3 to 4 weeks or a 50-mg tablet PO daily. Pain response and Karnofsky Performance Index (KPI) will be measured at intervals throughout the study. The anticipated time on study treatment is 4 months and the target sample size is 150 individuals.
Drug Penetration Into Bone After Repeated Oral Administration of Debio 1450 to Patients Undergoing...
Bone DiseasesInfectiousDebio 1450 is being developed for the treatment of staph (staphylococcal) infections. How fast and completely an antibiotic penetrates into bone is used to determine how effective it might be to treat infections related to bones or joints. Since bone has fewer blood vessels than other tissue (for example lung tissue or the skin), drugs have a harder time getting into them. It is important to find out how much of the antibiotic can get into the bone to help patients with bone infections.
XL184 For Relapsed/Refractory Multiple Myeloma (MM) With Bone Disease
Multiple MyelomaThis 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.