Active clinical trials for "Osteoporosis"

Clinical trial to assess the effectiveness of the supplement Colaren® associated with zoledronic acid 4mg/annually in the treatment of osteoporosis secondary, compared to standard treatment plus zoledronic acid 4mg/annually. The standard treatment will include 1gr of calcium/day and vitamin D supplement. In both cases, vitamin D levels will be determinated, which should remain at more than 30 ng/mL. Including men with osteoporosis secondary to HIV and men with osteoporosis secondary to any other cause (HIV negative). Vitamin D levels, bone densitometry and markers of metabolism, bone formation and bone resorption will be assessment. The all parameters above will be assessed basally (before the start of treatment), after starting the treatment, an assessment will be made at 12 weeks where vitamin D levels and bone markers will be measured. Meanwhile, at week 24 assess only vitamin D levels; and finally, at week 52 all parameters mentioned above will be measured.

Denosumab is a potent anti-resorptive agent and is now widely used in the treatment of osteoporosis. Although denosumab has excellent effect to increase bone mass and prevent fracture in FREEDOM study with very low complications, even up to ten years, it's effect is reversible. After holding the drug, circulating denosumab levels fall rapidly, and bone resorption reaching twice baseline levels for about 6 months. How to prevent bone loss after denosumab therapy is an important issue, especially when considering the compliance, persistence, or other comorbidities of the patient. We want to verify if zoledronic acid could be used as a sequential therapy after denosumab to prevent rapid bone loss by randomized clinical trial.

Osteoporosis is a bone disease that increases the risk of fractures. People aged 50-65 diagnosed with osteoporosis feel too young to have the disease. But this happens. They need to learn how to modify their lifestyle to minimize the chances of fractures. In this age group, a wrist fracture is usually the first sign of osteoporosis. Fracture risk increases if they are not taught to exercise, eat properly, and identifies fall risk factors early in their diagnosis. Some studies have looked at interventions for osteoporosis in women over the age of 65, but by this age they have likely already had a spine fracture. No studies have addressed the early-onset osteoporosis age group, intervening before spine fractures occur. I will develop an exercise, nutrition, and falls prevention education program to improve the strength, balance and knowledge of people aged 50-65 who had an osteoporotic wrist fracture. I will use this treatment approach and determine if it is more effective than the usual way of treating people with wrist fractures, determining if this is a better strategy for managing osteoporosis. I will have two groups of patients. First, those, over six weeks, receive twice weekly classes that include exercise and education. Here the focus is on bone health and fracture prevention. The control will receive usual physical therapy and the educational materials at the end of their study participation. The treatment will be randomly allocated to 74 men and women between the ages of 50-65 years of age who are 6-10 weeks post-fracture. The outcomes on both groups will be assessed and compared. I will focus on hand function, balance, fall hazard detection, and a bone health behaviour checklist. Using these outcomes, I can determine which treatment approach works best. Osteoporosis affects one in three women and one in five men, making this an important study to improve the lives for many Canadians. The risk of osteoporosis fractures increases with age, making early interventions critical.

A multicenter, randomized, double-blind, placebo-controlled phase III clinical study will be conducted to evaluate the efficacy and safety of LY06006 in the treatment of postmenopausal women with osteoporosis at high risk for fracture, as well as an exploratory population pharmacokinetic analysis of LY06006.

This prospective, single-site, single arm pilot study aims to assess the efficacy of Pulsed Electromagnetic Field (PEMF) exposure in the reduction of the decline in muscle strength, function and bone mineral density (BMD) in osteosarcopenia.

Acute phase response (APR) is one of the most common adverse events in osteoporosis with zoledronic acid treatment. It's reported that this reaction is related to the blockade of the mevalonate pathway, leading to isopentenyl pyrophosphate (IPP) accumulation. And the latter can active γδT cells in the circulation, resulting in inflammatory cytokine release. Statins can inhibit the conversion of HMG-CoA to mevalonate that may reduce the accumulation of IPP. Therefore, it is possible that statins can be taken in advance to reduce APR caused by zoledronic acid infusion.

HYPOTHESIS: - A multicomponent exercise program where strength exercises are performed with blood flow restriction obtains better values in densitometry and bone mass of osteoporotic patients with respect to the same multicomponent exercise program where strength is worked without flow restriction. INTERVENTION: The recruitment of the population will be carried out between July and November 2021, with the collaboration of the Consorci Sanitari de Terrassa (CST), which brings together a hospital center and different primary care centers (CAP). The primary care physicians and rheumatologists of the CST will receive an e-mail from the hospital management, informing them of the study to be carried out so that, if they consider it appropriate, they can inform their patients. Intervention of the intervention and control group: Each volunteer will be assigned to an intervention group either to the control group (CG) or experimental group (EG). The control group and intervention group will receive the same multicomponent exercise program, based on specific literature for being an effective, safe and feasible training for both elderly people {{2091 Bouaziz, Walid 2016;}} {{2092 Fragala,M. S. 2019;}}, with or without frailty {{2093 Cadore, Eduardo L 2014;}} {{2094 Casas-Herrero, Alvaro 2019;}} {{2088 Fernández-García, Ángel Iván 2020;}} and/or with osteoporosis {{2089 Moradell, Ana 2020;}}. The main difference between both groups is that the experimental group (EG) will perform the strength exercises with flow restriction (BFR) while the control group (CG) will not have any restriction. The periodicity of both groups will be 2 sessions per week, with a duration of 65 minutes per session and the duration of the intervention of 6 months and a follow-up 12 months after the beginning of the intervention (see scheme). The training will be supervised at all times by a physiotherapist with more than 10 years of experience in multicomponent exercise. The sessions will include both limb and trunk work and will have a clear functional objective, focusing on activities of daily living (ADL). Each session will work on all the basic physical abilities (strength, balance, endurance, flexibility and coordination) and will be divided into: 10 minutes of initial warm-up. This is divided into 8 minutes walking on a treadmill or cyclohergometer with an intensity corresponding to 30% of heart rate reserve. Followed by 2 minutes of active mobilizations in both upper and lower extremities. 20 minutes of strength exercises. These will be interspersed with the rest of the exercises and will include the different extremities and trunk. During the first month, training will be carried out with loads corresponding to 20% of 1 repetition maximum (RM) and from the second month onwards it will be increased to 30-35% of 1 RM. 10 minutes of resistance exercises. These exercises will be interspersed with the rest to make the session much more enjoyable. 10 minutes of coordination and balance exercises. These exercises will be interspersed with the rest of the activities. 5 minutes of flexibility. These exercises will be performed interspersed with the strength and endurance exercises. 5 minutes of return to calm and relaxation. To facilitate the monitoring of the researcher who will apply the intervention, each group will be subdivided into smaller groups (ratio of 5 subjects per researcher).

Balance control, physical activity and health related quality of life will be assessed before and after a 10 to 12 weeks training program as well as 6 and 12 months thereafter in 200 elderly (>60) with balance problems (100 with osteoporosis, 100 with Parkinson's disease). Osteoporosis subjects will be assigned to 3 groups (balance training, balance training and Nordic walking, or control group) and Parkinson's subjects to 2 groups (balance training or a control group). The training will be progressive and specific incorporating dual task exercises (directly related to an increased risk of falling). Clinical and laboratory gait and balance measures as well as questionnaires will be used to assess physical function and quality of life. An earlier study, investigating this training program in healthy elderly with balance problems showed that the training was well-tolerated and effective, with a significant increase in balance control, physical function and activity. In this study, we expect that an improvement in balance function, physical activity and health related quality of life, which will lead to a decreased number of falls, prevent and/or postpone incidence of a hazardous fall and thereby reduce the burden on the health care system. Our model for functional balance training and outcome methods will expand techniques and tools available to physical therapists and health care scientist treating and evaluating patients with loss of balance function. Elderly receiving therapy with the goal to improve or recuperate physical function and balance will benefit from this project.

This study is designed to measure the effect of evogliptin on bone metabolism in healthy volunteers.

Osteoporosis is a prevalent health concern among older adults and is associated with an increased risk of falls that can cause fracture, injury or mortality. Identifying the factors related to falls occurring within this population is essential for the development of effective regimes for fall prevention. Studies have shown that muscle quality and good posture alignments are critical for balance control in older adults. People are diagnosed with osteoporosis often combining with muscles weakness, and increased spine kyphosis leading vertebral, fractures and poor balance control, even falls. Therefore, improving muscle quality, strengthening weak muscles and correcting postural alignment are essential elements for fracture and fall prevention in older adults with osteoporosis. The long-term objectives of this work are to prevent fracture and fall in older adults with osteoporosis by improving the function of degenerative muscles using exercise training.