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Bone Diseases clinical trials

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NCT ID: NCT00965978 Completed - Osteoporosis Clinical Trials

A Study to Evaluate Food Effect on ONO-5920/YM529 Intermittent Formulation

Start date: July 2009
Phase: Phase 1
Study type: Interventional

The aim of the study is to evaluate the effects of food intake on the plasma concentration profile of YNO-5920/YM529 in post menopausal women.

NCT ID: NCT00935935 Completed - HIV Infections Clinical Trials

Study of Bone Disease in Older HIV-infected Adults

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

This study will look to see if there are changes in the blood cells that are associated with bone disease and sort out effects that are due to the HIV virus itself, the medications and see if faster aging occurs in the cells of HIV infected persons. Bone disease will be measured by a special X-ray called a DEXA scan. A DEXA scan is used by doctors to see if someone has normal bone mass for their age or if there is thinning of the bones. The purposes of this study are: - to learn how common bone disease is in HIV infected patients over the age of 50 years that receive their care at the CORE Center - to see what are the common causes of bone disease in older HIV infected persons - to see if there are differences in blood cells and levels of cytokines in patients who do or do not have bone disease, as this may help researchers determine the cause of bone disease.

NCT ID: NCT00913796 Completed - Metabolic Acidosis Clinical Trials

Metabolic Acidosis in Renal Transplant Patients

MART
Start date: December 2007
Phase: Phase 2
Study type: Interventional

Acidosis (accumulation of acid in the body) may be an underrecognized problem in patients after renal transplantation. It may have consequences on physical performance due to negative effects on bone and muscle metabolism. Therefore, the purpose of this study is 1. to determine the status of physical capacity and bone structure in renal transplant patients with metabolic acidosis 2. to study the effect of substituting base equivalents (citrate) on acid/base status of renal transplant patients with acidosis 3. to compare the status of physical capacity and bone structure in renal transplant patients with metabolic acidosis before and after substitution with citrate

NCT ID: NCT00904423 Terminated - Breast Cancer Clinical Trials

Ph I/II of Vitamin D on Bone Mineral Density & Markers of Bone Resorption

Start date: April 2009
Phase: Phase 1/Phase 2
Study type: Interventional

Aromatase inhibitors are potent suppressors of breast cancer growth, but side effects include bone loss, fractures, arthralgias and myalgias. We hypothesize vitamin D administration might be beneficial in treating these symptoms and to protect bone.

NCT ID: NCT00802607 Completed - Bone Diseases Clinical Trials

Collection of Tissue Specimens for Analysis and Establishment of Cell Cultures

Start date: December 2, 2008
Phase: N/A
Study type: Observational

This study will collect bone, cartilage, tendon, ligament, skin and fat tissue from patients undergoing surgery at Children's National Medical Center in Washington,

NCT ID: NCT00785824 Completed - Lactation Clinical Trials

African-American Bone Metabolism and Lactation Study

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

The primary aim of this study is to obtain measures of amino-terminal telopeptides of procollagen 1 (P1NP), a marker of bone formation, in lactating and non-lactating post-partum African-American women both at 6-8 and at 12-14 weeks post-partum, and to compare these values to those of normal controls. The secondary aim is to obtain at the same time points, measurements of Parathyroid Hormone-related Protein (PTHrP), additional markers of bone turnover [e.g. N-telopeptide of collagen cross-links (NTx), C-telopeptide of collagen cross-links (Ctx),bone specific alkaline phosphatase (BSAP) and osteocalcin (OC)], calcium and vitamin D metabolism in these subjects. These results will be compared with a non-African-American cohort of post-partum women and normal controls. The investigators hypothesize that African-American lactating women will have increased bone turnover when compared to non-lactating postpartum women and normal controls. The investigators further hypothesize that bone turnover is increased in lactating women independent of race.

NCT ID: NCT00774020 Completed - Clinical trials for Paget's Disease of Bone

Efficacy and Safety of Single Dose of 5 mg Zoledronic Acid in Chinese Patients With Paget's Disease of Bone (PDB)

Start date: October 30, 2008
Phase: Phase 4
Study type: Interventional

The purpose of this study is to document the efficacy and safety profiles of single intravenous dose of 5 mg zoledronic acid for the Chinese patients of Paget's Disease of Bone (PDB).

NCT ID: NCT00747994 Completed - Clinical trials for Paget's Disease of Bone

Genetic Study of Families Affected by Paget's Disease of Bone

PAGET
Start date: September 2007
Phase: N/A
Study type: Observational

Paget's disease of bone is a frequent bone disorder which usually starts after the age of 40 and which is characterized by bone pain and deformities. Although often without any symptoms, this disease may have severe complications such as fissures, fractures, neurological compression, or deafness. In some cases, it is a genetic disorder transmitted with a dominant autosomal pattern of inheritance: one of the two parents carrying the disease transmits it to his offspring with a risk of 50% for each child. Since 2002, the first gene involved in Paget's disease of bone is known and 14 mutations of this gene have been published. A study confirmed that the presence of those mutations was associated with younger age of onset and more extensive disease. Thus, the knowledge of those genetic factors in the relatives of an affected individual allows the screening of the patients with a higher risk for complications, who may benefit from a medical follow up and earlier treatment, in order to avoid complications. Indeed, Paget's disease of bone may be treated efficiently by bisphosphonates. This project aims at identifying and collecting over one year, 15 affected individuals affected by Paget's disease of bone and the relatives up to the second degree of relativeness (a total of 100 individuals is expected). The blood samples may be analysed in order to search for mutations of the previously known gene and/or to search for new mutations on new genes.

NCT ID: NCT00741377 Completed - Clinical trials for Multiple Myeloma Bone Disease

A Study to Assess BHQ880 in Combination With Zoledronic Acid in Relapsed or Refractory Myeloma Patients

Start date: January 2009
Phase: Phase 1
Study type: Interventional

This study has two portions, a phase I portion and a phase II portion. The purpose of the phase I portion is to assess the maximum-tolerated dose (MTD) and to characterize dose limiting toxicity (DLT) of escalating doses of BHQ880 (up to a maximum dose of 20 mg/kg) in combination with standard chemotherapy and zoledronic acid in relapsed or refractory multiple myeloma patients. The phase II portion of the study will also be conducted in relapsed or refractory multiple myeloma patients. Patients will be treated with various doses of BHQ880 or placebo in combination standard chemotherapy. In the phase II portion of the study zoledronic acid will be added after the first 28 days of therapy with BHQ880 or placebo and standard chemotherapy. This will allow any BHQ880-related changes in bone biomarkers to be detected in a zoledronic acid-free environment. The purpose of the phase II portion of the study, is to determine one or more doses of BHQ880 for further development based on dose-efficacy modeling. Efficacy is defined as time to first skeletal-related event and change in bone markers for bone resorption and formation relative to placebo. A skeletal-related event is defined as: - Pathologic fracture - Spinal cord compression - Requirement for either radiation or surgery to bone due to: - Pain - Prevention of imminent fracture - Stabilization of a fracture Biomarker and imaging endpoints will be assessed in both phases of the study. The pharmacodynamic effects of BHQ880 will be assessed by measuring biochemical markers of bone formation, resorption, and metabolism in serum and urine. Charges in serum DKK1 levels will be characterized. The size and number of lytic bone lesions as measured by bone survey (X-ray) or MRI will be assessed. In addition, bone mineral density (BMD) will be measured by DEXA scan and at selected sites with QCT scans.

NCT ID: NCT00740129 Completed - Clinical trials for Paget's Disease of the Bone

Re-treatment of Participants With Paget's Disease Using Zoledronic Acid

Start date: October 21, 2008
Phase: Phase 4
Study type: Interventional

The purpose of this study was to demonstrate that participants with Paget's disease of the bone who had responded to zoledronic acid treatment as participants in the core registration studies CZOL446K2304 and CZOL446K2305 and later experienced a relapse can be successfully treated with a 5 milligram (mg) infusion of zoledronic acid.