View clinical trials related to Osteoporosis.
Filter by:Vertebroplasty itself is challenged regarding its clinical efficacy. While two randomized controlled trials (RCTs) with substantial methodological problems have led to an intense discussion another RCT with larger case numbers, more representative inclusion criteria and a more consistent and sound methodology has revealed results that mirror the investigators' own clinical experience. In their daily practice, the investigators have further advanced their treatment concept and routinely apply prophylactic augmentations with VP using an algorithm. Biomechanical studies support their approach, but clinical studies are rare so far. Prophylactic augmentation with balloon kyphoplasty has not shown convincing effects in a small pilot study. Given the above mentioned methodological and clinical disputes and the call for high-evidence studies about VP, the investigators aim at generating a reliable sample size calculation and preliminary results for a future multicenter RCT about prophylactic adjacent level augmentation with VP in single level osteoporotic compression fractures.
The goal of this study is to determine whether two new, non-X-ray techniques can discriminate between high-energy fractures of normal bone (trauma) and low-energy fractures (fragility) of osteoporotic bone. The current gold-standard for assessing fracture risk areal bone mineral density (aBMD) by dual energy X-ray absorptiometry (DXA) is not particularly effective at identifying individuals who are at risk of suffering a fracture. Yet, there is a growing population of diabetics and elderly individuals prone to fractures. In effect, the age-related and diabetes-related increase in fracture risk is independent of a person's aBMD. These findings stress the urgency in developing diagnostic tools that can improve fracture risk prediction so that patients can be treated with the appropriate anti-fracture therapies.
The purpose of this study is to evaluate the tolerability of two different formulations of blosozumab in women who have reached menopause. This study will last approximately 12 weeks for each participant, not including screening. Screening is required within 28 days prior to starting the study.
The purpose of this proposal is to determine the long-terms effects of hormone and lifestyle factors on bone health in young women over a 20-year time period. It is our primary hypothesis that premenopausal women with irregular periods or endocrine issues related to estrogen will have significantly poorer low back and hip bone health when compared to regularly menstruating women. It is our secondary hypothesis that long-term assessment of changes in endocrine function and lifestyle behaviors will assist in establishing risk factors for osteoporosis in young women. This study will include 1000 premenopausal women. The women will participate in the collection of a blood sample, bone scan, body fat measures, and lifestyle questionnaires. In addition, we hope to use this initial study to develop a group of women to follow throughout menopause, with additional visits occurring every 5 years over the course of their life.
Osteoporosis is a disease that leads to impaired skeletal strength and increased fracture risk. Among 200 million osteoporotic patients (Tarantino, Cannata et al. 2007) most are diagnosed only after a fracture. We expect with our aging population to see a significant increase in the prevalence of osteoporosis. It is estimated that over 75% of osteoporotic patients are not diagnosed and do not receive treatment for their condition. This research plan describes a study for clinical validation of the novel ultrasound device (Bindex®, Bone Index Finland Ltd.). In a preliminary study, the technique has been validated in a Finnish postmenopausal woman population of 285 healthy and 56 osteoporotic subjects (n = 341 in total). Significant and good correlation was observed between Density Index (DI) determined with Bindex and femoral neck bone mineral density determined with DXA (r = 0.65 - 0.70). In addition, with determination of 90% sensitivity and specificity thresholds, significant number (65-75%) of patients could be diagnosed without additional verification with DXA. For validation of the technique in US population, our study plan is presented for determination of diagnostic thresholds for osteoporosis. Taken together, DI with Bindex, lumbar spine and femoral bone BMD with DXA are obtained from 500 postmenopausal women and 140 men. The study will be carried out at the HealthEast Osteoporosis Care service in Woodbury, MN. 1. To investigate the capability of DI for prediction of proximal femur and lumbar spine BMD; 2. To develop national diagnostic thresholds for DI in prediction of osteoporosis status with a reference population (American-Caucasian) of 500 (if prevalence of osteoporosis is 20%) post-menopausal females (50-90 years); 3. To investigate ability of Density Index + FRAX with BMI in fracture risk prediction; 4. To investigate correlation between lumbar spine or proximal femur BMD and Density Index in 140 men at wide age range (20-90 years), 70 with osteoporosis and 70 with normal or low bone mass. Determine diagnostic thresholds for DI in men.
The purpose of this study is to assess if estrogen replacement normalizes urinary calcium excretion in postmenopausal women with hypercalciuria and low bone mass and to assess for differences in response to estrogen replacement in women with familial hypercalciuria compared to nonfamilial hypercalciuria.
The purpose of this study is to assess to what extent sequential treatment with odanacatib results in incremental gains in bone mineral density (BMD) over time in female participants who have received at least 3 years of bisphosphonate therapy. It was hypothesized that odanacatib treatment would increase femoral neck BMD relative to placebo after 24 months.
Osteoporosis is an important health problem in the rapidly-aging demographic. Fragility fractures are devastating consequences of osteoporosis. The most common treatment approach in osteoporosis is inhibition of bone resorption with drugs like alendronate (ALN). Parathyroid hormone (PTH) stimulates bone formation and is the only anabolic drug available. Dual therapy with ALN and PTH is not as effective as single-drug therapy in preventing fracture. Bone progenitor cells (MSCs) are recruited to sites of bone remodeling when a growth factor called Transforming Growth Factor Beta (TGF-β1) is released from bone. Different osteoporosis medicines may have differing effects on this process. The effects of ALN versus PTH on bone progenitor recruitment in humans are unknown. This is a randomized, clinical trial of ALN, PTH, and calcium and vitamin D in post-menopausal women with low bone mass. Women will be treated for 3 months with ALN or PTH or calcium and vitamin D. Data collected will include bone biopsies for histomorphometry and micro computed tomography (µCT), bone marrow aspirates for molecular studies, peripheral blood to detect circulating bone progenitor cells and dual X-ray absorptiometry. The investigators hypothesize that in humans, PTH will 1) increase bone progenitor number, 2) enhance recruitment of bone progenitor cells to bone resorption sites, and 3) increase bone progenitor number in peripheral circulation. Furthermore, the investigators hypothesize that ALN treatment will have the opposite effect. Understanding the differences in bone progenitor cell activity and recruitment during osteoporosis therapy will provide a mechanistic rationale for effective use of PTH and anti-resorptive drugs in osteoporosis treatment.
This study will assess the safety, tolerability, pharmacodynamics, and pharmacokinetics of single doses of odanacatib in mature adolescents and young adults who are currently receiving glucocorticoid therapy. The primary hypotheses for the study are that a single dose of odanacatib is well tolerated in mature adolescents and following single dose administration of odanacatib 50 mg, there is no clinically important difference in AUC0-inf between mature adolescents and young adults.
The purpose of this study is to evaluate the efficacy and safety of bisphosphonates in long term treatment of osteoporosis.