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This study verifies efficacy of collaborative care with Smart Health Management Program developed for patients with chronic illness. The aim of the study is to observe the changes in clinical indicators, quality of life and health related behaviors when providing self-management programs with ICT for chronic disease patients.
The purpose of this study is to compare the efficacy and safety of Denosumab 60 mg produced by AryoGen Pharmed and Amgen Denosumab 60 mg among osteoporotic postmenopausal women. Postmenopausal women diagnosed with osteoporosis according to their Bone mineral density result (BMD), aged between 45 to 75 are included in this trial. This is a Phase III, randomized, two armed, double-blind, parallel, active-controlled,non-inferiority clinical trial. The eligible patients are randomized in a 1:1 ratio to receive Dyenix or Prolia® subcutaneous injections, at the beginning of the trial and every 6 months at month 6 and 12, in an 18-month study period. Along with, all women will receive daily supplements containing at least 1000 mg of elemental calcium (divided into two doses) and at least 400 IU vitamin D daily during 18 months of the study. The primary objective of this study is to assess non-inferiority of test- Denosumab 60 mg (Dyenix) to the reference Denosumab 60 mg (Prolia®) in terms of efficacy among osteoporotic postmenopausal women. The secondary objectives of this study are: To further compare efficacy of test- Denosumab 60 mg to reference Denosumab 60 mg; To assess the safety of test- Denosumab 60 mg compared to reference Denosumab 60 mg.
Body composition, bone mineral density (BMD), and body balance are important factors that threaten postural control. They act as vital elements in the vicious circle that leads to fracture occurrence in elderly population, particularly postmenopausal women.
Background: Back pain and osteoporosis with vertebral fractures are common conditions in elderly women and significantly affect their quality of life. A common complication of osteoporosis are vertebral fractures. Treatment with bone-specific drugs does often not help the pain condition caused by the vertebral fractures even when the progress of the disease has decreased. Vertebral fractures often result in deformation of the spine and poorer quality of life of the individual. The spinal kyphosis also affects the lung function and the effect of the kyphosis itself is severe. Alternative treatments of back pain may lead to reduced drug demand for pain. Physical activity is one of the most important factors that regulates bone mass and can also affect balance and fall risk positively. The back orthosis that we intend to use in the treatment study has been shown in some previous scientific studies to strengthen the muscles in the back and also decrease the pain. Purpose: The purpose of the study was to evaluate the effect of treatment of back pain in elderly women with an activating functional orthosis versus treatment with a group of physiotherapeutic tools and a control group for a six-month treatment period and follow-up after 12 months from the start of study. The aim was also to study elderly women with osteoporosis and back pain in a follow-up study of a cohort of women at high risk of osteoporotic fractures, with focus on back pain, functional capacity and quality of life. The aim was to study the effect of treatment with activating functional orthosis versus physiotherapeutic treatment in a group and a control group without treatment. The main outcomes will be the experienced perceived back pain and back extensor strength. Additional outcomes will be quality of life, balance, lung function and kyphosis. Biochemical markers for pain will be measured in the RCT (Randomized Controlled Trial). Significance: Evaluation of alternative treatment methods such as exercise by a physiotherapist and treatment with a functional orthosis will give new additional treatment options for our patients. An activating functional orthosis could reduce the use of analgesics and increase the quality of life of the affected women.
Osteoporosis after gastrectomy, which is characterized by both the loss of bone mass and the deterioration of bone architecture, is a serious complication in the long course after gastrectomy. The aim of the present study was to evaluate osteoporosis by using high-resolution peripheral quantitative computed tomography (HR-pQCT) in the long course after gastrectomy. In total gastrectomy and distal gastrectomy groups, at least 5 years should have elapsed since gastrectomy.
This is a single-center, open-label, dose-escalating study to evaluate the safety, pharmacokinetics, immunogenicity, and preliminary efficacy of single dose subcutaneous injection of a fully human monoclonal antibody of receptor activator for nuclear factor-κ B ligand (RNAKL) (code name: TK006) in postmenopausal women.
Randomized, Open-label, Single-dose, 3-period, 6-sequence, 3-way crossover Study
Clinical trial to investigate effect of voluntary upper extremity loading in combination with anabolic osteoporosis therapy.
Osteoarthritis (OA) and osteoporosis (OP) affect large numbers of the population. Around 8 million people in the UK are affected by OA and over 300,000 people present with fragility fractures in the UK each year. High impact exercise has been shown to improve markers of bone health but the effect of this exercise on the cartilage is less well understood. A six month, one leg, exercise program based on hopping will be carried out by a group of post-menopausal women. Post-menopausal women are particularly at risk from OP and the research should give information on the feasibility of this type of exercise program in this age group and the effect on cartilage. Participants will be aged between 55 and 70 (at least five years post menopause) with no conditions that would limit their ability to complete the exercise program. To assess changes in participants' cartilage and bone properties they will be asked to attend several meetings at Loughborough University. Before and after the exercise program participants will have bone density scans and MRI scans of the knee joint. A subset (n=4) will undergo high resolution bone scans that can demonstrate changes in bone structure. The intervention is a home based exercise programme lasting approximately 10 minutes per day. Initially this will be individualised to each participant with the end goal being daily exercise sessions. The programme will last for six months with supervised sessions offered throughout the trial. Using an intervention affecting just one leg will allow the research team to use the other leg as a control. The research team hypothesise that in a population of post-menopausal women, a six month, unilateral exercise intervention will improve bone mineral density at the proximal femur with no negative effects on articular cartilage.
The investigators will conduct a cross-sectional study of bone density, bone microarchitecture, vertebral fractures and trabecular bone score in 25 patients with acromegaly treated with Pegvisomant, the growth hormone (GH) receptor antagonist for at least 1 year and with normal insulin-like growth factor-1 (IGF-1) levels. This study aims to describe the bone architecture and associated biochemical indices of bone turnover and metabolism in patients with active acromegaly and how these are altered with treatment of the disease.