View clinical trials related to Osteoporosis, Postmenopausal.
Filter by:The aims of ZOLARMAB2 are fourfold. First, the investigators want to investigate if multiple infusions of zoledronate can prevent the rebound activation of bone turnover and the subsequent bone loss in patients previously treated with denosumab and if there is difference between infusing zoledronate at fixed time-points after the last injection of denosumab or when bone turnover is increased. Second, the investigators want to investigate if bone loss will resume after controlling the rebound activation of bone turnover during the first year after denosumab discontinuation and if this can be prevented by yearly infusions of zoledronate. Third, the investigators want to investigate the underlying pathophysiological mechanisms by investigating biochemical markers, osteoclast and osteoblast activation signals in the bone and bone marrow, and the pool of preosteoclasts/mature osteoclasts before and after treatment with zoledronate. Fourth, the investigators want to investigate the effect of denosumab discontinuation on muscle mass and muscle strength and on insulin sensitivity.
70 postmenopausal women, aged 50 to 60, who are vitamin D deficient and diagnosed with osteoporosis or osteopenia with T score of DEXA of lumbar spine (L1 to L4) was less than or equal -1 and their body mass index between 25 and 30 kg/m2. They will be divided into two groups by randomization. 35 postmenopausal women in Group (A) will undergo three weekly sessions of UV therapy in addition to routine aerobic activity and vitamin D supplements (800 IU) daily for three months. For three months, group (B), which consists of 35 postmenopausal women, will undergo daily aerobic exercise and vitamin D supplementation (800 IU) only. The amount of serum 25-hydroxyvitamin D was measured using ELISA kits, bone mineral density of lumber spine was measured by dual energy X-ray absorptiometry (DEXA), and the torque of knee flexors and extensors was evaluated using the Biodex System 3 isokinetic dynamometer,
This study will provide objective evidence for the efficiency and safety of minodronate in the treatment of postmenopausal osteoporosis with low back pain protocol. Furthermore, it will be helpful to evaluate the quantitative relationship between bone metabolic markers (BTM) and bone mineral density (BMD) in patients with osteoporosis under different ages.
To evaluate the effect of 1 year of risedronate treatment on the prevention of bone loss after denosumab discontinuation in denosumab-treated post-menopausal osteoporosis for a year
A 24-month prospective, open-label, randomized, multicenter, multinational, non-inferiority pragmatic clinical trial evaluating zoledronate single or double infusion versus oral alendronate following denosumab
Post-menopausal osteoporosis and the resulting fractures are an important cause of disability and loss of independence. They also increase the risk of morbidity and mortality. Given potential side effects, hormone replacement therapy is no longer recommended for menopausal women with risk of becoming osteoporotic. The very significant decrease in the use of these treatments is suspected of contributing to a resurgence in the incidence of osteoporotic fractures, particularly in women before the age of 70. There is a need for prevention of osteoporosis.
Sixty-eight postmenopausal women diagnosed with osteoporosis aged between 50 and 60 years were randomly allocated to one of two equal sets. The drug treatment group received calcium and vitamin D3 supplement daily for 12 weeks. While the drug/laser acupuncture group received laser acupuncture therapy for 20 minutes per session 3 times weekly, in addition to the same calcium and vitamin D3 supplement.
The high annual incidence of osteporosis and its high prevalence , means that more and more resources are being devoted to its diagnosis, prevention and treatment in primary care. This pathology is defined as a skeletal disorder characterized by an alteration in bone strength, mainly reflecting a poor integration of bone density and quality. The reduction of the mass and the alteration of the microstructure of osteoporotic bone lead to an increase in its fragility and an increase in the risk of suffering bone fractures. If we add to this the alterations in balance observed in older people, the possibility of fracture and increased fragility increases. It is estimated that every 3 seconds there is an osteoporotic fracture and it is considered that every year 8.9 million fractures of this type occur worldwide. Fragility fractures are estimated to be associated with significant morbidity and mortality. In the case of hip fracture as a consequence of osteoporosis, only 30-45% of surviving cases recover pre-fracture functional status and 32-80% suffer some form of significant dysfunction, thus representing a high economic and social cost. Associated with osteoporosis, numerous studies have also observed a decrease in strength and/or muscle mass (sarcopenia), thus increasing the fragility and deterioration of the patient suffering from osteoporosis. Tokeshi et al. observed that patients with osteoporotic fractures had less muscle mass compared to patients without osteoporosis. Hoo Lee and Sik Gong describe that lower extremity muscle mass and loss of grip are closely related to the occurrence of an osteoporotic vertebral fracture and numerous investigations show the relationship between grip strength and osteoporotic fractures in the elderly. For the diagnosis of osteoporosis, double beam X-ray densitometry (DEXA) is used and osteoporosis is considered to be present when the osteoporosis values are below 2.5 standard deviations (SD) of the peak bone mass, the maximum value reached in young women. At the therapeutic level, pharmacology is the treatment recommended in clinical practice guidelines. However, due to poor adherence and adverse effects, the recommendation of physical activity programs is becoming more and more popular to increase mineral density and bone quality, either as adjuvant treatments or as the treatment of choice. Various research and clinical guidelines recommend the use of therapeutic exercise as part of the treatment of osteoporosis. The National Osteoporosis Foundation of the United States concludes that the practice of exercise improves, among other benefits, the quality of bone mass. Likewise, different systematic reviews have shown that multicomponent training in older people is effective in preventing or maintaining bone mass, especially when such exercises are performed with high load or high impact or when performed by postmenopausal women. Along these lines, the American College of Sports Medicine and recent research demonstrates how strength work at moderate to high load intensity can not only stimulate bone metabolism, but also improve the quality of life of those who practice it. But in spite of the bone benefit observed with high loads for bone tissue, not all elderly people can do it, either because of the fragility that many of them present, or because of the mechanical stress that this type of exercise produces in their joints. For this reason, one of the possible alternatives that we have found for some decades is training through the use of global vibration (GV) or body vibration through the use of vibrating platforms. This type of vibration generally starts in the extremities and the limbs themselves are used as a sounding board for the vibrational stimulus to the rest of the body. This type of equipment has allowed a less demanding training from the articular point of view in a less demanding approach to other exercise programs in patients and has shown significant improvements in bone formation rate, bone mineral density (BMD), trabecular structural and cortical thickness in osteporotic bone tissue. But despite the wide use of vibrating platforms for training in elderly people, it is not free of contraindications such as patients with recent fracture, deep vein thrombosis, osteosynthesis of lower limbs, hip prosthesis, aortic aneurysm or diabetic foot injury, for this reason have emerged focal vibration devices (VF). This tool allows the application of the vibratory stimulus in a specific and repeated way in a part of the body; as well as the control of the amplitude that reaches a certain tissue avoiding the disadvantages of the vibratory platforms in which the region and the tissue to be treated cannot be selected.
Nonalcoholic fatty liver disease (NAFLD) is a chronic, metabolic liver disease that is closely related to obesity, type 2 diabetes mellitus (T2DM) and metabolic syndrome (MetS) in a bidirectional mode. NAFLD affects approximately 25% of the worldwide population. NAFLD refers to a phenotypic spectrum, including steatosis, inflammation and fibrosis, which can lead to cirrhosis and hepatocellular carcinoma in a minority of patients. However, despite its high prevalence, morbidity and mortality, as well as the extensive research in the field, there is not to-date a licensed medication specifically for NAFLD. Emerging evidence supports a potential association between NAFLD and osteoporosis; the prevalence of osteoporosis is probably higher in patients with NAFLD and, vise versa, the prevalence of NAFLD may be higher in patients with osteoporosis. In this context, it has been proposed that certain medications for osteoporosis may also prove to be beneficial to NAFLD. Denosumab, a human monoclonal IgG2 antibody against the receptor activator of nuclear factor kappa-B (NF-κB) ligand (RANKL), is currently an established treatment for osteoporosis and other metabolic bone diseases. The axis RANKL-receptor activator of nuclear factor NF-κB (RANK)-osteoprotegerin (OPG) has been demonstrated as a key regulator of bone metabolism and, when dysregulated, it contributes to the pathogenesis of osteoporosis and other metabolic bone diseases. Interestingly, experimental studies have shown that circulating and hepatic RANKL may be upregulated in mice with diet-induced NAFLD, rendering RANKL a potential contributor to the pathogenesis of NAFLD, and ideally, a promising pharmacological target. On the other hand, bisphosphonates, another established, first-line treatment for osteoporosis, are expected to have no significant effect on hepatic metabolism in patients with NAFLD due to their pharmacokinetics and mechanism of action. This is a prospective non-randomized study which aims to investigate the comparative effect of denosumab versus bisphosphonates on hepatic steatosis and fibrosis in women with postmenopausal osteoporosis and concomitant NAFLD.
This is a post-marketing drug intensive monitoring surveillance with an observational, non-interventional design. The objectives are to compare the incidence of hypercalcemia in patients with and without calcium intake (including dietary supplements, excepting calcium from meals), and to monitor the type, incidence, severity, and relevance of other adverse drug reactions,including urolithiasis.