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NCT07464171
What is the study about? This study is testing "Dora", an AI-powered assistant that can make phone calls to patients, for use in the Fracture Liaison Service (FLS). The FLS is a clinic that helps prevent more bone fractures after an initial "fragility fracture" (a break that happens easily, usually due to osteoporosis). Why is this being done? FLS clinicians often have to spend a lot of time on routine phone calls for assessments and follow-ups. If Dora can safely and accurately collect patient information, it might save time for staff and still give patients a good experience. What will happen to patients in the study? Invitation and consent - Patients with a new fragility fracture who are eligible will be invited to take part after informed consent. Dora call - Patients will receive an automated phone call from Dora, at the start of their FLS pathway and at follow-up. At intake, Dora will ask about risk factors for bone problems (e.g., smoking, alcohol use, family fracture history). At follow-up, Dora will ask about medication use, side effects, falls, or new fractures. Clinician call - Soon after, patients will have their usual phone appointment with an FLS clinician, who asks similar questions. Surveys/interviews - Patients will be asked to complete a short questionnaire and take part in an optional interview to say how they felt about talking to Dora. What about clinicians? Clinicians involved in the FLS pathway will be asked to complete a short survey and to take part in an optional interview to understand how useful Dora's reports might be in their work. Who can take part? Patients - Age 50+, English-speaking, with a new fragility fracture, and able to use the phone. Clinicians - Those working in FLS or similar bone health services. How long will it take? Each patient might be involved for up to about 7 months. The whole study will take about a year.
NCT06973109
The goal of this clinical trial is to learn if romosozumab (Evenity) can improve bone and muscle health in postmenopausal women with osteoporosis who are undergoing lumbar spine surgery. The main questions it aims to answer are: * Does romosozumab improve bone strength and reduce the risk of complications during and after spine surgery? * Does romosozumab increase muscle mass and help patients recover better from surgery? Researchers will compare romosozumab (a monthly injection) to alendronate (a weekly pill), both approved treatments for osteoporosis, to see which is more effective in this surgical setting. Participants will: * Be randomly assigned to receive romosozumab or alendronate * Take standard vitamin supplements and receive a one-time dose of zoledronic acid near the end of the study * Attend five study visits over about 12 months * Undergo bone scans, muscle imaging, and complete health questionnaires before and after surgery
NCT04800367
The overarching goal of the research program is to define optimal treatment for premenopausal women with clinically significant fracture syndromes that require medical therapy. The investigators hypothesize that romosozumab will be associated with improvements in bone mass and microarchitecture in premenopausal women, and also that the responses and response rates will exceed those observed in premenopausal women treated with teriparatide. The investigators will test this hypothesis in this phase 2 study of 30 premenopausal women with idiopathic osteoporosis (IOP) who will receive 12M of romosozumab 210 mg monthly followed by 12M of denosumab 60 mg SC q6M. Aim 1 will define the within-group effects of this regimen. Aim 2 will compare results from participants treated with romosozumab-denosumab to the investigator's well-characterized historical controls treated with teriparatide followed by denosumab.
NCT06731608
Osteoporosis is a disease that weakens bones so the bones may break easily. The risk for osteoporosis increases with age in both women and men. Osteoporosis affects 10 million older adults in the US. Osteoporosis is a common cause of broken bones in the hips and legs. Broken bones can lead to disability, nursing home placement, and death. Because of the dire consequences, a broken hip or leg is one of the most dreaded injuries for older adults. Many studies confirm that a simple regimen of exercise, healthy diet and bone-strengthening medications can improve overall recovery after a broken hip or leg. This regimen can prevent a person from becoming disabled, having future fractures, and even prevent death. Many older adults have surgery in a hospital after breaking a hip or leg. Then older adults go to a skilled nursing facility (SNF) for rehabilitation. Care in SNFs varies greatly. Some patients do not receive the regimen that the investigators know is most beneficial to improve bone health and recovery. Even patients who get exercise, healthy diet, and bone-strengthening medication in the SNF, may not continue with the regimen once patients go home. Therefore, the investigators want to implement and test OsteoPorotic fracTure preventION System (OPTIONS). OPTIONS is a program that will integrate the regimen into the care that is provided in SNFs and after discharge to the community. OPTONS will provide information about exercise, diet, and bone-strengthening medication. OPTIONS will provide doctors, clinical staff, patients, and care partners with the information these stakeholders need to carry out the best-practice regimen. The investigators are partnering with PointClickCare, a large cloud-based healthcare software provider, with SNFs and community care sites across the US. The investigators will include 32 SNFs from different US areas. The investigators will flip a coin to assign SNFs to the intervention (OPTIONS) or the control arm (enhanced usual care) of the study. Enhanced usual care is the care that is typically provided in SNFs after a fracture and adding information about a publicly available fall prevention toolkit. The investigators are using an "implementation science" approach that requires the investigators to get input from the OPTIONS study's vast stakeholder community throughout the study. The OPTIONS study's stakeholders include patients, care partners, clinicians, and professional organizations. The research question is, can using OPTIONS in SNFs and in the community after discharge improve physical function and quality of life in older people in the year after a hip or leg fracture? The investigators are measuring patient-reported outcomes. The investigators will include 1553 patients across the 32 facilities. The investigators have selected outcomes that are important to patients. Specifically, the investigators are measuring patient-reported function and quality of life. The investigators are also measuring patient-reported falls and fractures. The investigators will track the number of patients who die during the study. This study's hypothesis is that patients who receive OPTIONS will report better physical function (i.e., can walk and take better care of themselves) than those who receive enhanced usual care. The investigators also hypothesize that patients that receive OPTIONS will report a better quality of life than those who receive enhanced usual care. This study will provide sound data about the effectiveness of OPTIONS. OPTIONS could then be spread to other SNFs and community-based programs. This would ensure that all older people receive the right care after a hip or leg fracture.
NCT06304428
The goal of this clinical trial is to compare three care models for optimizing medications and preventing falls with broken bones in patients receiving rehabilitation after a hospitalization for a broken bone. The primary outcome is injurious falls, with secondary outcomes measuring how the process of care is changed and capturing patient-reported outcomes valued by stakeholders. The main questions this study aims to answer are: * Which of the three models is more effective in preventing falls with fractures? * What are the differences in patient-centered outcomes amongst the three models? These include pain, depression, anxiety, sleep, medication side effect burden, and fear of falling. * What are the differences in osteoporosis treatment and medication burden? The three care models are: a Deprescribing Care Model designed to reduce or stop fall-related medications, a Bone Heath Service Model designed to provide osteoporosis evaluation and management, and an Injury Prevention Service Model offering both services. 42 SNFs will participate in this study. The three models will be incorporated into the routine care of patients at these facilities who are receiving rehabilitation after a hospitalization for a fracture. All care models will be delivered remotely to patients in the SNF and after they transition home by a post-fracture nurse consultant supported by an interprofessional team. This study has three aims. See Detailed Description for more details. This ClinicalTrials.gov record represents the Comparative Effectiveness Aim of the protocol.
NCT06830005
To assess the effectiveness of 16bit's Rho AI (artificial intelligence) software at identifying known cases of osteoporosis. 800 de-identified images from January 2007 to January 2024 will be accessed to test the software prospectively.
NCT05666310
Osteosarcopenia is a geriatric musculoskeletal syndrome characterized by co-existence of osteoporosis and sarcopenia (low skeletal muscle mass, strength, and/or functional capacity). There is strong evidence of overlap between the pathophysiology of osteoporosis and sarcopenia (muscle-bone crosstalk). This research plan will further explore the relationship between bone and muscle, and provide new information about effect of osteoporosis medications on muscle health in older adults who are under treatment for osteoporosis.
NCT07329543
Osteoporosis is a common condition that increases the risk of bone fractures. Although antiresorptive treatments such as bisphosphonates and denosumab are effective in increasing bone mineral density, some patients continue to experience fractures despite treatment. Advanced glycation end-products (AGEs) accumulate in the body over time and can negatively affect bone quality by altering collagen structure and increasing inflammation. The role of AGE burden in predicting response to osteoporosis treatment has not been fully established. This prospective cohort study aims to evaluate whether baseline AGE burden, measured non-invasively using skin autofluorescence, is associated with treatment response in patients receiving antiresorptive therapy for osteoporosis. Changes in bone mineral density, bone turnover markers, and fracture outcomes will be analyzed in relation to baseline AGE levels. The results of this study may help identify patients at risk for reduced treatment response and residual fracture risk.
NCT07281586
Maintaining bone mineral density (BMD) after discontinuing denosumab (Prolia) is a major clinical challenge, as rapid bone loss commonly occurs when treatment is stopped, especially after more than three years of use. Standard sequential therapy with bisphosphonates such as zoledronic acid (Aclasta) often fails to fully prevent BMD decline, and most bone loss occurs within the first year, making effective suppression of the rebound effect essential. This study investigates whether a de-escalation strategy-using half-dose denosumab (30 mg every six months) combined with sequential zoledronic acid-can better preserve lumbar spine BMD after long-term denosumab therapy. Eligible participants include postmenopausal women and men ≥50 years old with osteoporosis or osteopenia-related fractures who have received ≥3 years of denosumab. The open-label trial applies stratified randomization based on denosumab duration (\<4 years vs. ≥4 years), assigning 22 participants to each group. Control group: standard therapy with one zoledronic acid infusion at the end of denosumab's effect and a second infusion one year later. Intervention group: half-dose denosumab plus zoledronic acid at study entry, a second half-dose denosumab injection at six months, and a second zoledronic acid infusion at twelve months. The study aims to determine whether this combined tapering-plus-bisphosphonate approach more effectively prevents lumbar spine BMD loss compared with conventional sequential therapy.
NCT05913219
This study will be underpinned by the new MRC guidelines for developing a complex intervention with a participatory design methodology that uses evidence-based research and behaviour change models alongside COSMIN methodology for validating a measure. Research question: To what extent does gaitQ's smart cueing system improve people with long-term conditions including people with Parkinson's (PwP's) gait? Is it effective in the everyday environment? What factors are associated with good mobility? What is the impact of cueing on healthy people? Aims and objectives: To finalise the product development and evaluation comprising (1) algorithm refinement and (2) monitoring system development. To evaluate the reliability, concurrent validity, and potential for efficacy, as determined by responsiveness in response to the gaitQ product using gait data collected in laboratory environments. To prepare for market entry and NHS adoption: early economic modelling, pricing, marketing strategies, and early adopter partnerships. Design: Participatory design with testing for validity, reliability and responsiveness Participants: This will involve healthy people and people with long-term conditions affecting their movement, including people with Parkinson's \[PwP\]. Additional patient groups will be investigated, including stroke, and people with hip/knee injuries. Methods The Researchers will collect movement data using the gaitQ system, which monitors and cues, to both collect data and cue in the lab environment and investigate the reliability of the measure, concurrent validity of the metric to gold standard gait capture, the responsiveness of measures to the cueing system and usability for participants and clinical teams. To determine reliability, 60 participants will be invited to repeat testing on a second visit. Researchers will describe participants' conditions using standard questionnaires and their mobility and functioning. This study will be underpinned by the new MRC guidelines for developing a complex intervention with a participatory design methodology that uses evidence-based research and behaviour change models to identify intrinsic and extrinsic factors that contribute to a given outcome in a specific population.
NCT07162168
This study is a retrospective analysis that uses abdominal CT scans, which were originally taken for other medical reasons, to estimate bone age. By applying advanced deep learning methods, the investigators aim to develop a tool that can evaluate bone health and detect early signs of osteoporosis without requiring additional scans or radiation. This approach may help doctors better understand bone aging, improve screening for bone weakness, and provide patients with more personalized information about their bone health.
NCT07253493
Weight-bearing exercises (e.g., running, jumping, whole-body vibration) are widely practiced due to their beneficial effects on bone development and their role in the prevention and treatment of osteoporosis. However, the underlying neuroregulatory mechanisms responsible for these positive effects have not yet been fully understood. Two main neuromodulatory mechanisms have been proposed in the literature: (i) spinal reflexes originating from muscle spindles (stretch reflex, tonic vibration reflex), and (ii) the bone myoregulation reflex (BMR) based on load-sensitive osteocytes. It is well established that increased voluntary contraction and the associated rise in background EMG activity, that is, motor neuron pool activity, enhance muscle spindle-based reflex responses (such as the H-reflex and tendon reflex). In contrast, it has been demonstrated that the H-reflex is suppressed during bone-loading activities such as single-leg stance, jumping, or whole-body vibration. This study is based on two hypotheses: * As mechanical loading increases, Ia inhibitory effects intensify, leading to greater H-reflex suppression. * During whole-body vibration, the H-reflex is suppressed due to Ia inhibition. If this inhibition originates from load-sensitive receptors-osteocytes-and thus from the BMR, then in osteoporosis, where osteocyte number and function are reduced, H-reflex suppression will be diminished. The aim of this research is to test these hypotheses. Confirmation of these assumptions would suggest that reflex control during weight-bearing exercise occurs predominantly through osteocyte-mediated BMR mechanisms rather than muscle spindle-based mechanisms such as the stretch or tonic vibration reflex.
NCT03232476
Clinical trial to investigate effect of voluntary upper extremity loading in combination with anabolic osteoporosis therapy.
NCT07187518
Osteoporosis is a widespread medical condition among older people. It causes the bones to weaken and become more likely to break. Osteoporosis and bone fracture risk are currently evaluated by looking at clinical risk factors and measuring bone mineral density (BMD). The lower the BMD is, the higher the risk of osteoporotic fractures in the future. An X-ray device called DXA is the main tool used to diagnose osteoporosis and fracture risk clinically. DXA measures two-dimensional BMD in the hip and spine. However, DXA devices are often not readily available at the point of care. The POROUS ultrasound device offers a different approach by measuring various properties of the outer layer of the bone in the lower leg. It has several advantages over DXA: (1) higher and three-dimensional image resolution; (2) the ability to measure bone properties without radiation; (3) portability, it is a mobile medical device; 4) lower operational costs. For this clinical study, we will recruit men and women between the ages of 21 and 55. Most of these study participants will not have evident clinical risks for osteoporosis. The goal for including this age group is to estimate the range of BMD values for younger people before BMD declines with age. In a separate clinical study, we are recruiting older participants. The study is anticipated to last one year. Our major research questions are: * Can the POROUS ultrasound device estimate BMD? * How does its performance compare to DXA? * What is the safety of the new device? The participants will: * answer questions about their medical history. * be measured for height and weight. * be examined with the two devices, DXA and POROUS.
NCT06279078
The goal of this retrospective/observational study is to compare the clinical outcomes between the high-cumulative-dose group and the low- cumulative-dose group of oral/inhaled corticosteroid in the long-term management of asthma patients. The main hypothesis are: i. High cumulative dose of corticosteroid is related to the prevalence of osteoporosis/osteoporosis in the long-term management of adult asthma. ii. High cumulative dose of corticosteroid can affect populations that have a high-risk of osteoporosis (females over 50 years of age). iii. High cumulative dose of corticosteroid is related to the prevalence of diabetes mellitus, hypertension, and hyperlipidemia in the long-term management of adult asthma. iv. High cumulative dose of corticosteroid affects bone metabolism-related diagnostic tests and laboratory values and the prescription rate of bone metabolism-related medications.
NCT05010590
In this research study we want to learn more about the effect of two different FDA-approved medications in the treatment of osteoporosis.
NCT06530394
This study aims to examine whether Greek yogurt (GY) consumption will lead to beneficial changes in bone metabolism and inflammation, in senior adults, male and female, when combined with regular exercise (senior fit classes; GYEX) and without exercise (GYNE). It is hypothesized that compared to a control group (senior fit classes, no GY; NYEX), an 8-week GY consumption intervention in senior adults with and without exercise will lead to positive effects on body composition, and markers of bone metabolism and inflammation such that the anabolic and anti-inflammatory markers of these physiological processes will increase more than any training-induced catabolic and pro-inflammatory markers (i.e., more than measures observed in the NYNE group).
NCT03699228
In this nationwide multi center study the investigators combine the low dose chest CT scan data with QCT technology, to measure the BMD of spine, VAT and liver fat in the health check subjects. The aim of this study is to evaluate the performance of QCT in the health check field, and further to evaluate the prevalence of osteoporosis, obesity and liver steatosis in health check population across China.
NCT06668090
Diabetes mellitus type 2 is associated with low bone turnover and increased risk of bone fractures. Bone mineral density, however, is increased and cannot explain the increased fracture risk per se. The pathophysiology is not completely understood, but the decrease in bone turnover is believed to cause an accumulation of microcracks in bone tissue leading to bone fragility. The decrease in bone turnover may arise directly from insulin resistance or indirectly through formation of advanced glycation end-products. The main aim objective is to investigate how increases in insulin sensitivity following 12 weeks of moderate intensity bike exercise affect biochemical bone turnover markers and biomechanical bone properties in individuals with diabetes mellitus type 2.
NCT06551155
Osteoporosis (OP) is one of most common age-associated and chronic metabolic bone diseases, featured by a decrease of bone mineral density (BMD) that increases the risk of bone fractures.OP guidelines agree that Dual-X-ray Absorptiometry (DXA) is the gold standard for BMD assessment, but for the different OP stages screening and diagnosis, BMD by itself is not an accurate predictor. Thus, OP is often misdiagnosed. Aim of the this study is to improve a tool for OP diagnosis based on the ability of circulating peripheral blood mononuclear cells (PBMCs) to maintain or not their in vitro viability (IRCCS Istituto Ortopedico Rizzoli European patent n.3008470 March 21, 2018) for the measurement of the different OP severity levels, also considering specific gender related differences.