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Osteoporosis clinical trials

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NCT ID: NCT00697983 Completed - Osteoporosis Clinical Trials

Cohort Study on Associations Between Purinergic Receptor SNPs and Osteoporosis Risk

ATPBone
Start date: August 2008
Phase: N/A
Study type: Observational

Background: Osteoporosis is a high-prevalence disease with a strong genetic component. Nucleotides, including ATP (adenosine 5'-triphosphate) and its purinergic receptors, play a role in bone physiology. Single nucleotide polymorphisms (SNPs) in the P2X7 receptor gene were recently found to be associated with fracture risk in a cohort of postmenopausal women. Objective: To investigate associations between purinergic receptor SNPs and osteoporosis risk in humans. Genetic data from a fracture cohort in the Netherlands with high prevalence of osteoporosis will be analyzed. Furthermore, effects of aberrant purinergic receptor signalling on bone turnover markers will be assessed ex vivo. Design: The cohort will include app. 1,000 fracture patients of 50 years and older, who will be recruited at the Maastricht University Medical Center during standard medical follow-up after a clinical fracture. The standard medical follow-up includes assessment of bone mineral density (BMD) by Dual-Energy X-ray Absorptiometry (DXA), if necessary followed by medication for osteoporosis. Prior to medication, blood samples will be collected from fracture patients to be genotyped for purinergic receptor SNPs and analyzed for biochemical markers of bone turnover. Systemic correlates of osteoporosis will be compared between osteoporotic subjects (i.e. low BMD) and non-osteoporotic controls (i.e. normal to high BMD). Subsequently, whole blood assays in patient subgroups (n=20 per subgroup), based on BMD and purinergic receptor SNPs, will be performed to evaluate ex vivo effects of ATP and related nucleotides bone markers. Study population: Patients of 50 years and older attending an outpatient osteoporosis clinic at the Maastricht University Medical Center for standard medical follow-up after a clinical, non-pathological fracture. Primary outcome parameters: BMD and purinergic receptor SNPs. Secondary outcome parameters: Bone markers.

NCT ID: NCT00697957 Completed - Osteoporosis Clinical Trials

Bone Adaptation to Impact Loading

Start date: May 2002
Phase: N/A
Study type: Interventional

Ageing populations have made osteoporosis and fragility fractures a major public health concern worldwide. Half of all women and 30% of all men will suffer a fracture related to osteoporosis during their lifetime. While medical prevention of this immense problem is impossible at population level, it is necessary to find efficient preventive strategies. Exercise is one of the major prevention approaches because one reason behind the increasing burden of osteoporosis is the modern sedentary lifestyle. However, the optimal type, intensity, frequency, and duration of exercise that best enhances skeletal integrity are still largely unknown. We conducted a 12-month population-based randomized controlled exercise intervention in 120 premenopausal women. The aim was to investigate the effect of impact exercise on bone mineral density, geometry and metabolism in healthy women with the intention of assessing the intensity and amount of impact loading with a novel accelerometer-based measurement device. Training effects on risk factors of osteoporotic fractures, physical performance and risk factors of cardiovascular diseases were also evaluated. This study demonstrated that 12 months of regular impact exercise favoured bone formation, increased bone mineral density in weight-bearing bones, especially at the hip, and led to geometric adaptations by increasing periosteal circumference. Bone adaptations had a dose- and intensity-dependent relationship with measured impact loading. Changes in proximal femur were threshold-dependent, indicating the importance of high impacts exceeding acceleration of 4 g as an osteogenic stimulus. The number of impacts needed to achieve this stimulation was 60 per day. Impact exercise also had a favourable effect on physical performance and cardiorespiratory risk factors by increasing maximal oxygen uptake, dynamic leg strength and decreasing low-density lipoproteins and waist circumference. Changes were dose-dependent with impact loading at wide intensity range. Bone adapts to impact loading through various mechanisms to ensure optimal bone strength. The number of impacts needed to achieve bone stimulation appeared to be 60 per day, comparable to the same number of daily jumps. If done on a regular basis, impact exercise may be an efficient and safe way of preventing osteoporosis.

NCT ID: NCT00697463 Completed - Osteoporosis Clinical Trials

Forteo for the Treatment of Unexplained Osteoporosis in Premenopausal Women

IOPForteo
Start date: August 20, 2008
Phase: Phase 2/Phase 3
Study type: Interventional

Idiopathic osteoporosis (IOP) is an uncommon disorder in which otherwise healthy young individuals sustain one or more low-trauma fractures. Teriparatide [PTH(1-34)], which is FDA approved for treatment of osteoporosis in men and postmenopausal women, works by stimulating bone formation. The investigators hypothesize that teriparatide will significantly increase bone density (BMD) and improve bone structure in premenopausal women with IOP.

NCT ID: NCT00696644 Completed - Osteoporosis Clinical Trials

A Study for Teriparatide in Severe Osteoporosis

ISSO
Start date: June 2008
Phase: N/A
Study type: Observational

This observational study will evaluate the incidence of new vertebral and non vertebral fragility fractures in patients with severe osteoporosis treated with anabolic drugs. This study will also evaluate BMD, compliance to treatment, back pain and the health-related quality of life.

NCT ID: NCT00693667 Completed - Osteoporosis Clinical Trials

Study of PH3 for the Prevention of Osteoporosis in Postmenopausal Women

PH3
Start date: February 2008
Phase: Phase 2
Study type: Interventional

The primary objective of this clinical study is to evaluate the effectiveness and safety of PH3 for the prevention of osteoporosis. The secondary objectives are to identify the optimal dosage for subsequent studies and to provide basis for the next confirmatory study in study design, endpoints, and study methodologies.

NCT ID: NCT00692913 Completed - Osteoporosis Clinical Trials

A Study to Test the Effect of MK0217A on Vitamin D Inadequacy in Postmenopausal Women With Osteoporosis (0217A-262)

Start date: June 2008
Phase: Phase 3
Study type: Interventional

A study designed to see if the study drug will increase blood levels of vitamin D, bone mineral density (BMD), improve biochemical markers of bone turnover, and reduce the number of falls as compared to women receiving standard care for osteoporosis.

NCT ID: NCT00688246 Completed - Breast Cancer Clinical Trials

Bone Mineral Density in Postmenopausal Women at Increased Risk of Breast Cancer And Who Are Receiving Exemestane on MAP3

Start date: July 10, 2008
Phase:
Study type: Observational

RATIONALE: Learning about the effect of exemestane on bone mineral density in postmenopausal women at increased risk of breast cancer may help plan treatment, decrease the risk of broken bones, and help patients live more comfortably. PURPOSE: This research study is measuring bone mineral density in postmenopausal women at increased risk of developing breast cancer who are receiving exemestane on clinical trial CAN-NCIC-MAP3.

NCT ID: NCT00683163 Completed - Osteoporosis Clinical Trials

PTH & Ibandronate Combination Study (PICS)

PICS
Start date: May 2008
Phase: Phase 2/Phase 3
Study type: Interventional

This study will test in several innovative ways, several different combinations of PTH and oral monthly ibandronate for the treatment of osteoporosis in postmenopausal women. The intension is to provide other options for treatment than the current standard 2 year course of drug therapy. These options may lead to treatment where the two years of therapy are spread over several years.

NCT ID: NCT00680953 Completed - Osteoporosis Clinical Trials

Denosumab Fracture Intervention Randomized Placebo Controlled Trial in Japanese Patients With Osteoporosis

DIRECT
Start date: May 2008
Phase: Phase 3
Study type: Interventional

Evaluate the efficacy and safety of denosumab in the treatment of involutional (postmenopausal and senile) osteoporotic subjects with prevalent fragility vertebral fracture(s)

NCT ID: NCT00679198 Completed - Osteoporosis Clinical Trials

Improving Osteoporosis Care in High-Risk Home Health Patients

Start date: March 2009
Phase: N/A
Study type: Interventional

SPECIFIC AIMS: We propose a three-year study to develop a high-intensity intervention to improve osteoporosis care and test a novel intervention in a group-randomized trial of 27 home health offices and 1,000 patients referred to home health care with a history of fracture. Aim 1. Develop an intervention to promote osteoporosis treatment that includes: (1) training to enhance nurse-patient and nurse-physician risk communication regarding osteoporosis and fracture risk; (2) automated prompts within the home health agency's electronic medical record system to promote appropriate osteoporosis management; and (3) implementation of osteoporosis-related standardized care pathways and order sets. Aim 2. Conduct a group-randomized trial to test the effectiveness of the intervention to promote initial use of osteoporosis medications and adherence to treatment after discharge from home health. We hypothesize that: H1: Patients in the intervention group will have increased initial receipt of osteoporosis prescription medications and calcium/vitamin D supplements to prevent and treat osteoporosis compared to patients receiving usual care; H2: Patients in the intervention group will demonstrate increased persistence in the use of these therapies compared to those receiving usual care. Secondary Aims (SA) will include exploratory analyses of fracture related morbidity and mortality, patient-reported quality of life, and health services utilization and costs.