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Osteoporosis, Postmenopausal clinical trials

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NCT ID: NCT06264401 Not yet recruiting - Clinical trials for Postmenopausal Osteoporosis

Treatment Exercises With Core Stability and Dynamic Resistance Exercise for Postmenopausal Women With Osteoporosis

Start date: February 22, 2024
Phase: N/A
Study type: Interventional

osteoporosis is a common disease that affect most of postmenopausal women. various treatment procedures are used to avoid future complain among postmenopausal population.

NCT ID: NCT05902078 Not yet recruiting - Clinical trials for Postmenopausal Osteoporosis

Eldecalcitol and Calcitriol in Postmenopausal Women With Low Bone Mineral Density or Mild Osteoporosis

EFFECT
Start date: June 2023
Phase: Phase 4
Study type: Interventional

To investigate the efficacy and safety of eldecalcitol in postmenopausal women with low bone mineral density (BMD) or mild osteoporosis through a randomized, open-label, parallel controlled trial with calcitriol as the control.

NCT ID: NCT05645289 Not yet recruiting - Clinical trials for Postmenopausal Osteoporosis

Efficacy and Safety of Minodronate in Patients With Low Back Pain

Start date: January 1, 2023
Phase: Phase 4
Study type: Interventional

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.

NCT ID: NCT05538377 Not yet recruiting - Osteoporosis Clinical Trials

Effect of Focal Vibration Within a Multicomponent Exercise Program for Older Women With Osteoporosis a Single-blind Clinical Trial

Start date: December 1, 2022
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT05433207 Not yet recruiting - Clinical trials for Postmenopausal Osteoporosis

Post-Marketing Drug Intensive Monitoring Surveillance of EDIROL in Patients With Postmenopausal Osteoporosis

Start date: August 1, 2022
Phase:
Study type: Observational

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.

NCT ID: NCT05402852 Not yet recruiting - Clinical trials for Osteoporosis, Postmenopausal

Effectiveness and Safety of EuBone® Capsules for Bone Health in Postmenopausal Women

Start date: June 1, 2022
Phase: Phase 4
Study type: Interventional

EuBone is prepared by mixing eucommia ulmoides extract, fructus ulmoides extract and dodder extract in proportion. The aim of this study is to evaluate the effectiveness and safety of EuBone® capsules in slowing bone loss, preventing bone loss, and improving quality of life compared with placebo in Postmenopausal women.

NCT ID: NCT05060380 Not yet recruiting - Osteoporosis Clinical Trials

Feasibility of a Novel Resistance Exercise in Individuals With Osteoporosis

Start date: June 1, 2024
Phase: N/A
Study type: Interventional

The aim of the 6 month randomized controlled trial is to investigate the feasibility of a novel progressive muscle resistance exercise in postmenopausal women with low bone mass.

NCT ID: NCT04864509 Not yet recruiting - Clinical trials for Osteoporosis, Postmenopausal

The Effects of Melatonin Treatment on Bone, Marrow, Sleep and Blood Pressure

Start date: May 1, 2021
Phase: Phase 4
Study type: Interventional

Melatonin protects your bones while losing fat! This was previously demonstrated by our group. The mechanisms behind these findings are still elusive, and the aim of the present study is to assess the mechanisms. In a double-blinded randomized controlled trial 40 postmenopausal woman are randomized to receive either 10 mg melatonin or placebo nightly for three months. Changes in gene expression in marrow cells will be assessed through micro array. Markers of bone metabolism will be assessed through biochemical markers. Cardiovascular health will be measured by tonometry and 24h blood pressure. The results of the study will contribute with important knowledge about the beneficial effects of melatonin making it an interesting supplement to known treatment regimens against osteoporosis and overweight.

NCT ID: NCT04760145 Not yet recruiting - Osteoporosis Clinical Trials

EFFECT OF FLOW RESTRICTION ON BONE QUALITY WITHIN A MULTICOMPONENT EXERCISE PROGRAM FOR OLDER WOMEN WITH OSTEOPOROSIS.

Start date: July 1, 2021
Phase: N/A
Study type: Interventional

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).

NCT ID: NCT04719650 Not yet recruiting - Clinical trials for Postmenopausal Osteoporosis

Clinical Pharmacokinetics and Pharmacodynamics Study of Different Doses of Zoledronic Acid

Start date: October 2021
Phase: Phase 4
Study type: Interventional

The recommended dosing regimen of zoledronic acid in Chinese osteoporosis patients is completely in accordance with the one of 5 mg per year abroad that based on the dosing regimen in Paget's disease. This dosing regimen lacks the actual supportive clinical data of Chinese patients. In addition, the overall incidence of acute phase response, the main adverse event after the first infusion, in Chinese patients is higher than that in Caucasian patients population. Moreover, the results of the similar drug clinical study in the Japanese patients shown that the purpose of effective treatment for osteoporosis could be achieved with half of the dosage in Caucasian population. Thus, it could be inferred from these that the dosing regimen of zoledronic acid might be inappropriate in Chinese osteoporosis patients. Therefore, the main purpose of this clinical trail is to compare the zoledronic acid pharmacokinetic and pharmacodynamic characteristic of different doses in Chinese postmenopausal subjects with low bone mass or osteoporosis and explore the best dosing regimen in Chinese patients.