View clinical trials related to Osteoporosis.
Filter by:The primary objectives of the study are to assess the safety and tolerability of AGA2118 after single subcutaneous or intravenous administration in healthy men and postmenopausal women and to assess the safety and tolerability of AGA2118 after multiple subcutaneous administrations in men and postmenopausal women.
This study is a multicenter, randomized, double-blinded, placebo-controlled Phase III clinical study to evaluate the clinical efficacy and safety of MW031 in Chinese postmenopausal osteoporotic subjects with increased bone fracture risk .
Lumbar fusion is an accepted and effective technique for the treatment of lumbar degenerative disease. As the population ages, disability associated with spinal pathology and spinal surgery is rapidly increasing and there is a concomitant increase in prevalence of osteoporosis which is a detrimental factor for Lumbar fusion and instrumentation. Osteoporosis-related bone fragility is a primary reason for spinal fusion failure, implant fixation failure, and vertebral compression fractures above or below the fusion sites. Denosumab is a human monoclonal antibody against RANKL, it inhibits osteoclast mediated bone destruction and has been found to be effective in treating osteoporosis, including reducing bone turnover markers, increasing bone mineral density (BMD), and reducing fractures. But few studies focus on the effects of Denosumab on lumbar fusion. In this study, we include osteoporotic patients with lumbar degenerative disease who have had lumbar interbody fusion surgery. The patients were randomized to either treatment of Denosumab or no treatment. All these patients are followed at 3, 6, 9, 12 months postoperation. During these periods, we detect bone metabolism and bone fusion of these patients. Finally, we would report whether Denosumab can improve bone metabolism and promote bone fusion or not.
The research will be conducted as a prospective, post-market, multi-center study within Europe. The maximum number of subjects to be treated is 150 across up to 20 sites. This will be a non-randomized and open-label study. The study will collect procedural, short- and long-term data on the safety and clinical performance of AGN1 LOEP in the post-market setting in European countries where AGN1 LOEP is commercially available. AGN1 is intended to form new bone in voids in the proximal femur of women with osteoporosis.
This is a randomized, controlled pilot study to evaluate the feasibility and acceptability of a single 2-hour culinary medicine intervention for bone health among individuals with age-associated low bone mass.
Osteoporosis is an important public health issue that may result in a high fracture risk in the elderly population. There is general consensus that physical exercise decreases the risk of osteoporotic fractures by reducing the risk of falls and increasing bone strength. Although long-term high-intensity exercise programs have been shown to be successful in early post-menopausal women, a high-intensity exercise program appears to be less attractive to older post-menopausal women and may cause a lack of compliance in the long term and result in injury. Some studies have described falls and fractures as side effects of exercise.Whole-body vibration (WBV) therapy is an easy-to-apply alternative therapy for those who do not wish to initiate or continue pharmacological treatments and cannot perform high-impact exercises and is associated with high patient compliance. WBV therapy is among the promising new interventions for the prevention and treatment of osteoporosis and is defined as mechanical vibration applied in a standing or supine position without any restrictions on frequency (hertz), amplitude (millimeters), magnitude (vibration acceleration due to gravity, g) and cumulative WBV dose. The evidence obtained from animal studies have shown that WBV can be an effective method for increasing bone mass and improving bone structure and strength. Some human studies have shown that WBV can positively affect BMD and improve neuromuscular parameters associated with falls in post-menopausal women.Small changes in posture can have a significant effect on the extent to which a plantar-based mechanical stimulus is actually transmitted to the spine or hip; the stimulus is likely to be weakened by the inevitable changes in posture, which occur due to aging and osteoporosis. For these reasons, we aimed to examine the effect of high frequency and low-magnitude horizontal vibration therapy in post-menopausal women without being affected by posture in the present study.
The objective of the proposed work is to determine whether administration for 12 months of romosozumab (evenity) followed by 12 months of denosumab (prolia) will maintain bone mass at the knee in subjects with chronic SCI.
Due to the fact that bone mineral density (BMD) is a not enough sensitive parameter for assessment of the bone quality and that the changes in BMD are gradually, extension of the clinical follow up is recommended. On that way the result will be more reliable. Therefore the protocol "TOP 2-5" is the extension of TOP 1-study with a slight change of the study design. All subjects will be treated with Panaceo. It will be a "pear control", where the patient is control to himself, or herself (each patient from "placebo group (TOP1) can be compared after further years of threatment. Additionally, extension of the follow up will provide an assessment of the fracture risk in a more reliable manner, which is considered as the most preferably outcome in majority clinical studies of osteoporosis treatment, because it is the most important requirement for the acceptance by the regulatory agencies (FDA, EMA).
Inflammatory bowel disease (IBD) is considered a risk factor for the development of osteoporosis, which leads to an increased risk of fractures. There is no data on bone quality obtained with imaging techniques other than bone densitometry such as Trabecular Bone Score (TBS), 3D bone densitometry (DXA-3D) or quantitative bone ultrasound (QUS). The TBS study can provide information on bone microarchitecture in these patients, with TBS values expected to be lower than those of subjects without IBD, with a decrease of up to 50 points in this parameter. Primary objective: to evaluate and compare TBS values in patients with IBD and in a control group of volunteers without IBD or known metabolic bone pathology, adjusted for age, sex and body mass index (BMI). Secondary objectives: to evaluate and compare results in DEXA parameters, QUS, DEXA-3D, biochemical parameters and FRAX data between patients with IBD and controls. To evaluate the prevalence of vertebral fractures analyzed by VFA. As well as to evaluate the evolution in one year of all these parameters in patients with IBD. Prospective observational study with a cohort of patients with IBD and another of volunteers without IBD or metabolic bone pathology, adjusted for age, sex and BMI. Baseline bone quality data will be analyzed by bone densitometry, TBS, DEXA-3D and QUS, fractures assessed by VFA and bone remodeling markers in both cohorts. Subsequently, a one-year analysis of the parameters of the IBD cohort will be performed.
To minimize fracture risk, diverse and varied training of high intensity (multimodal training) is recommended to increase bone strength. However, the effectiveness of different training programmes performed in community settings remain uncertain. The present study aimed to evaluate the feasibility and the effectiveness of 19-week of multimodal training in a local community center in Copenhagen, Denmark. The health promotion initiative had special emphasis on musculoskeletal health in postmenopausal women.