Clinical Research Directory

The PREVENT Trial: a Pragmatic Cluster Randomized Controlled Trial of a Multifaceted Fracture Prevention Model for Long-term Care

Hip fractures occur nearly twice as often for older adults residing in long-term care as they do in older adults of a similar age still living in other settings. Hip fractures are the leading cause of hospitalization and often result in loss of independence, problems with walking and sometimes death. To address this problem the PREVENT (Person-centered Routine Fracture PrEVENTion in LTC) program was designed for use in long-term care homes. PREVENT uses a tool ("fracture risk calculator") based on a residents electronic health record to capture who is most at risk of fracture due to osteoporosis and falls. The program then trains the health care team including doctors, pharmacists and nurses on the latest recommendations on how to best assist residents and their families in making treatment decisions. The healthcare teams are also given tools that help them stay on track such as templates for ordering medications, strategies to reduce falls and fractures and making care plans. The study will examine if this program is effective for decreasing hip fractures by assigning some homes to receive the PREVENT program (intervention group) and some homes to usual care (control group) and comparing the results.

The Optimised Use of Romozosumab Study

OPTIMIST is a two-year, randomised, active controlled, open-label, multicentre intervention trial. OPTIMIST includes 3 treatment groups each comprising combinations of romosozumab (ROMO) and zoledronate (ZOL) treatment used in standard doses (210 mg monthly (sc) and 5 mg yearly (iv), respectively). The study will investigate if it is possible to maximize the effect of romosozumab by giving it in 2 periods of 6 months interrupted by zoledronate for 12 months compared to romosozumab for 12 months uninterrupted followed by zoledronate for 12 months. The investigators will also evaluate if 6 months of romosozumab followed by 18 months of zoledronate is non-inferior to the standard regimen of romosozumab for 12 months followed by zoledronate for 12 months.

EffCaMgCit to Prevent Mineral Metabolism and Renal Complications of Chronic PPI Therapy

Proton pump inhibitors (PPIs) are widely used for the control of gastric ulcer-gastritis, erosive esophagitis (gastroesophageal reflux disease), peptic ulcer disease (duodenal ulcer), and heartburn. Despite their efficacy, their use has been implicated in possibly causing fragility fractures (osteoporosis), hypomagnesemia (magnesium deficiency) and increased risk of chronic kidney disease (CKD). The current trial represents the investigators ongoing effort to discern whether these complications could be averted by effervescent calcium magnesium citrate (EffCaMgCit).

Functional Muscle-Bone Incongruity Index (FKUI): A Prospective Observational Study

The Functional Muscle-Bone Incongruity Index (FKUI) is a novel approach developed to evaluate the relationship between muscle function and bone health. This prospective observational study aims to investigate the clinical applicability of FKUI, which combines handgrip strength, total hip bone mineral density (BMD), and lumbar-hip BMD discordance. Approximately 200 adult participants undergoing routine DXA assessment will be enrolled. The study will examine whether the combined evaluation of muscle function and bone health parameters provides a more comprehensive assessment of musculoskeletal status than individual measures alone.

Trial of Parkinson's And Zoledronic Acid

This home-based study is a randomized (1:1) placebo-controlled trial of a single infusion of zoledronic acid-5 mg (ZA) for the prevention of fractures in men and women aged 60 years and older with Parkinson's disease and parkinsonism with at least 2 years of follow-up. A total of 2650 participants will be enrolled and randomized in the United States. Participants, follow-up outcome assessors, and study investigators will be blinded to assigned study treatment. This trial is funded by the National Institute of Aging.

Safety and Efficacy Clinical Trial of the Vessel-X® Bone Filling Container System

Osteoporotic vertebral compression fractures (OVCFs) are a common and serious complication of osteoporosis, particularly among elderly and postmenopausal patients. OVCFs may result in severe pain, functional impairment, spinal deformity, and reduced quality of life. Conventional conservative treatments, including bed rest, analgesics, and bracing, may provide limited symptom relief. Minimally invasive vertebral augmentation procedures, such as vertebroplasty and kyphoplasty, have been widely used to improve clinical outcomes; however, risks including bone cement leakage and incomplete vertebral restoration remain concerns. The Vessel-X® Bone Filling Container System, manufactured by Central Medical Technologies Inc. (CMT), is a third-generation vesselplasty technology designed for percutaneous vertebral augmentation procedures. The system utilizes an implantable biocompatible polyethylene terephthalate (PET) container with a microporous structure for controlled bone cement delivery. The implant remains within the vertebral body after cement injection and is designed to reduce cement leakage while maintaining vertebral height restoration and pain relief. This post-market clinical study evaluates the safety and clinical effectiveness of the Vessel-X® Bone Filling Container System at two medical centers in Taiwan with a total target enrollment of 146 subjects: Tri-Service General Hospital (TSGH): 86 subjects randomized in a 1:1 ratio to the experimental and control groups. Taoyuan General Hospital, Ministry of Health and Welfare (TYGH): 60 subjects randomized in a 1:1 ratio to the experimental and control groups. The primary objective is to evaluate the safety of the device by assessing the incidence of unanticipated serious adverse device effects (USADEs). Secondary objectives include evaluation of pain reduction measured by the Visual Analogue Scale (VAS), functional recovery assessed by the Oswestry Disability Index (ODI), and radiographic outcomes including vertebral height restoration and kyphotic deformity correction.

Effects of Cycle Therapy vs Sequential Therapy With Romosozumab and Denosumab in Postmenopausal Osteoporosis Patients

This study is a prospective, randomized, controlled clinical trial comparing the efficacy of a 24-month cyclic therapy regimen (6 months of Romosozumab followed by 6 months of Denosumab, repeated for two years) versus a traditional sequential treatment regimen (12 months of Romosozumab followed by 12 months of Denosumab). The goal is to determine which approach yields better therapeutic outcomes and to optimize drug strategies for osteoporosis patients.

Fragility Fracture Liaison Service Project

Aims: to Establish the FLS services at the National Taiwan University Hospital (NTUH) and its Beihu Branch (BB). Method: From Jan., 2014, two related fracture liaison services (FLSs) following the 13 'Capture the Fracture Best Practice Standards' were implemented at the National Taiwan University Hospital (NTUH) health care system. The main hospital (MH) program enrolled patient with 1) new hip fracture 2) newly identified radiographic vertebral fractures or 3) clinical vertebral fractures from both inpatients and outpatients. The Beihu branch (BB) program enrolled only the later two types of patients from outpatients. During the whole study period, two programs planed to enroll 600 fracture patients. Each patient would be assessed at baseline, and every 4 month for at least one year.

Anti-osteoporosis Medication Monitoring and Management Service

BACKGROUND: One-year adherence to oral anti-osteoporosis medication (AOMs) was only about 30%. In recent years, efforts have been made to change the delivery of these medications from oral form to injection form every, 3, 6 or 12 months to increase adherence. However, both patients and providers are sometimes confused about the multiple choices. Also, patients may receive extra medications if providers did not keep tract of their previous AOM uses or patients may changes providers. There were urgent needs to provide AOM monitoring and management services to improve cares. OBJECTIVES: To establish a anti-osteoporosis medication management service at National Taiwan University Hospital and its BeiHu Branch. METHODS: Participating physicians will select those eligible for services and refer to study coordinators. Study coordinators will conduct baseline assessments on osteoporosis/fracture risks, record medical conditions, AOMs, provide educations on osteoporosis, fracture, sarcopenia, fall, medications, nutrition, and exercise. They also arrange return clinic visit, telephone reminder and follow up for patients, and communicate with providers on regular bases. the investigators plan to enroll 500 patients with 18-month follow up for each.

Radiographic Cortical Thickness of the Humerus in Detecting Post-Stroke Regional Bone Loss

Post-stroke immobilization and reduced weight-bearing frequently lead to significant regional bone mineral density loss and asymmetry, particularly in the paretic upper extremity, which increases fracture risks. While Dual-Energy X-ray Absorptiometry (DXA) is the gold standard for evaluating systemic bone loss, it primarily focuses on axial or lower extremity sites and lacks universal accessibility. Since routine shoulder radiographs offer an opportunistic screening tool to evaluate regional bone quality without additional radiation , this study aims to compare proximal humerus cortical bone thickness between the paretic and non-paretic sides in stroke patients and assess its correlation with systemic DXA values to determine its clinical utility. This cross-sectional, observational study involves a retrospective data analysis of patients aged 18 and older who experienced a single unilateral stroke at least 6 months prior and present with clinical hemiparesis. Eligible participants must have concurrent standard anteroposterior shoulder radiographs and DXA measurements available from their routine clinical follow-ups. Patient demographic data, stroke characteristics, Brunnstrom stages, and systemic DXA measurements (femoral neck and lumbar spine T-scores and bone mineral density values) are systematically recorded for analysis. Cortical bone thickness measurements are performed using ImageJ software on standard radiographs at points 10 cm and 12 cm distal to the highest point of the humerus. To ensure reliability, measurements for both the paretic and non-paretic sides are conducted independently by two researchers who are completely blinded to the DXA results. Statistical analyses, including paired t-tests or Wilcoxon tests and Pearson or Spearman correlations, will be used to compare the sides and evaluate the relationship between radiographic cortical thickness and systemic bone density.

Evaluation of Osteoporosis Support After a Severe Osteoporotic Fracture in Women Over 50 Years in University Hospital

Evaluate the support of osteoporosis in women over 50 years with severe osteoporotic fractures (hip, vertebral, rib, Humeral, pelvic fractures) in the Nîmes University Hospital taking prediction of treatment of osteoporosis as criterion.

Estimation of Osteoporosis' Prevalence in France: Pilot Study in the Department of the Alpes-Maritimes

The purpose of this study is to estimate Osteoporosis' prevalence in France and is a pilot study in the Department of the Alpes-Maritimes.

Clinical Study to Predict the Risk of Bone Fractures With the POROUS Ultrasound Device

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. However, most bone fractures occur in people who do not have very low BMD values. This means that osteoporosis and fracture risk are often not diagnosed. Many of these non-diagnosed patients would benefit from treatment to reduce the probability of bone fractures. 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. The POROUS ultrasound device measures various properties of the outer layer of the bone in the lower leg. It has several advantages over DXA: (1) its image resolution is higher and three-dimensional; (2) it can detect bone changes without radiation; (3) it can detect these bone changes early and how they change over time. For this clinical study, we will recruit men and women over 55 years old. Most will have clinical risk factors, such as background diseases, for developing osteoporosis. The study is anticipated to last 4 years. Our major research questions are: * Can the POROUS ultrasound device predict fracture risk? * 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, and take a physical test. * be examined for the presence of 'silent' fractures in the spine. * be examined at the beginning and end of the study with the two devices, DXA and POROUS. * be called by telephone every six months and asked if they suffer from new bone fractures, take any medication that might affect their bones, or if their health status has changed. The participants will be monitored for 3 years.

Study of a Bone Assessment Technique, Bone Mineral Analyser, Concerning the Prediction of Improvement in Bone Status After an Infusion of Zoledronic Acid in Osteoporotic Women

* Collection of epidemiological data * Biological assessment as part of routine care. * Measurement of the Hurst coefficient at D0 * Measurement of bone density and TBS on D0 * Zoledronic acid infusion the month following inclusion * phone call at 1 month (observance of zoledronic acid) * Measurement of bone density, calculation of the Hurst coefficient at M12

U.S. Prospective Evaluation of EPIONE Device for Percutaneous MSK Procedures

The goal of this investigational device exemption is to evaluate the Epione assistance for introducer placement during percutaneous procedures in musculo-skeletic (MSK) structures of the pelvis and the spine in adults. The main question is the determination of the rate of feasible procedures assisted by the Epione device Participants will undergo their procedure(s) as planned by their physician. If they accept to participate to the study, the differences with standard of care will be: * The use of the Epione device to place the introducer(s), instead of freehand placement if they do not participate * Additional CT or CBCT scans during the procedure.

Contribution of Bone to Urine Citrate

Identification of the mechanisms by which bone contributes to urine citrate could lead to alternative explanations for and approaches to hypocitraturia. This proposal to explore the role of bone in urine citrate addresses the mission of the CMMCR to discover new mechanisms and innovative therapies for diseases of mineral metabolism. The results will be used to apply for extramural funding to further examine the nonrenal regulation of UCit. Hypothesis: Serum citrate is a function of bone citrate formation dependent on both bone mass and bone turnover. 20 subjects with osteoporosis naïve to treatment will be identified to examine bone parameters that correlate with ΔUcit/Δk. Use of potent anti-osteoporotic therapies to increase the likelihood of identifying significant bone turnover and BMD correlations with ΔUcit/Uk will take place in this study. Plan to achieve the following aim: * Correlate ∆ Ucit/∆k in response to acute KCit load with: 1. Bone turnover marker at baseline 2. BMD at baseline 3. Change in bone turnover markers at 1 month and 6 months with each osteoporosis treatment modality (anti-resorptive agents such as Zoledronic acid or Denosumab, or the Anabolic agent Romosozumab) 4. Change in bone mineral density at 6 with each osteoporosis treatment modality (anti-resorptive agents such as Zoledronic acid or Denosumab, or the Anabolic agent Romosozumab)

Digital Implementation of the German S3 Clinical Practice Guideline for Multimorbidity

The web application gp-multitool.de is a digital tool for implementing the German S3 clinical practice guideline for multimorbidity of the German Society of General Practitioners and Family Physicians in primary care. The tool enhances evidence-based and patient-centered care by assessing and providing information relevant for the primary care of this patient group. This cluster-randomised clinical evaluation study examines the effectiveness of an intervention based on gp-multitool.de in general practitioner (GP) practices in Germany.

GLP-1R Actions on Muscle and the Skeleton

The GRAMS study objectives are to assess the musculoskeletal changes that occur after weight loss using GLP-1 based therapy. A lifestyle intervention with diet and exercise is included to assess any mitigating effects are provided, versus a control group with regular exercise and diet.

Mediterranean Diet and Progressive Resistance Training Effects on BMD and Bone Turnover in the Elderly

This randomized controlled trial was designed to investigate the effects of progressive resistance training (PRT) combined with a Mediterranean diet on bone mineral density (BMD) and bone turnover markers (BTMs) in older adults. Participants underwent a detailed medical history assessment, clinical examination, and dietary evaluation. Individuals who met the inclusion criteria provided written informed consent prior to participation. All procedures were conducted in accordance with the Declaration of Helsinki, and the study protocol was approved by the Ethics Committee of Manouba University (no. C.S. ISSEP.KS N˚040/2024). Eligible participants were randomly allocated to either the experimental group (EXP; n = 22) or the control group (CON; n = 19). The intervention lasted 12 months. During this period, the EXP group participated in supervised PRT sessions combined with a Mediterranean diet intervention, while the CON group received no structured intervention.

Peripheral Mononuclear Cells to Screen, Monitor and Stratify the Population at Risk of Osteoporosis and Fractures

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.

Osteoporosis and Sarcopenia Prevention in Middle-Aged Population

This initiative is designed to yield substantial and multi-level benefits for the Hong Kong community by pioneering a transformative model of preventive healthcare. It represents the largest randomized controlled trial for osteoporosis and sarcopenia prevention in the region, adopting a comprehensive approach to fracture prevention through innovative fitness, lifestyle, and digital strategies. The study's primary objective is to evaluate the efficacy of preventing fractures, osteoporosis, and sarcopenia through an incentivized program of fitness and lifestyle modifications in adults aged 40-60. The secondary objectives include: (1) to validate the use of simple, low-cost measures (grip strength and InBody body composition analysis) as reliable proxy indicators for osteoporosis and sarcopenia risk relative to the gold-standard DEXA scan; (2) to develop a formal, standardized clinical protocol for early detection and prevention, including specified DEXA anatomical measurement sites, for use by healthcare professionals in primary and community care settings; (3) to assess changes in exercise behavior, musculoskeletal health, physical function, health literacy, and participant engagement with the digital (AI chatbot) support system; (4) to analyze the cost-effectiveness of the intervention compared to standard care or pharmacological treatment, including an assessment of healthcare utilization and Quality-Adjusted Life Years (QALYs). After baseline screening and consent, participants are randomly assigned to one of two groups (1:1 ratio) with intention-to-treat principles. The Control Group will receive passive, static support. This involves participating in one initial FUN Day, receiving standard exercise videos, using a passive chatbot for data reporting, undergoing start and end DEXA scans (which require a co-payment), completing a 3-month assessment, and receiving souvenirs at the study start and end. Meanwhile, the Intervention Group will receive active, dynamic support designed to build and reinforce healthy habits. This involves participating in the initial FUN Day, a reinforcement FUN Day at 2 months, nine mandatory structured exercise touchpoints, using an active chatbot with reminders, feedback, and gamification, undergoing start and end DEXA scans (which require a co-payment), completing a 3-month assessment, and receiving ongoing incentives and souvenirs at multiple points. Therefore, researchers will compare between the control and intervention groups to see if intervention can prevent osteoporosis and sarcopenia at a population level. All participants will undergo a series of assessments at specific timepoints. This includes two DEXA scans (at the study start and in the fourth year, requiring a participant co-payment), InBody composition analysis, and physical health assessments (e.g., grip strength, balance, cardiovascular fitness). These assessments will be performed at baseline (during the first FUN Day), 3 months, 12 months, 24 months, and 36 months. A long-term follow-up will continue for up to 10 years to monitor adverse health events such as falls and fractures. Participants will also complete questionnaires via an AI chatbot at baseline, 3 months, and annually during follow-up. The collected data will encompass health literacy (e.g., osteoporosis/sarcopenia knowledge scores), digital engagement (e.g., chatbot responsiveness), and economic outcomes (e.g., incremental cost per Quality-Adjusted Life Year \[QALY\] gained). Data analysis will employ appropriate statistical methods to compare outcomes between the control and intervention groups across all assessments and timepoints.

Smart Wearable Device (gaitQ): Walk Better Project

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.

Clinical Validation of BBCT-hip

The clinical study is aimed at assessing the accuracy of the in silico methodology BBCT-hip. BBCT-hip takes as inputs the subject-specific height and weight, and the CT scan of his femur to predict the risk of fracture for the femur upon falling. In the study, 150 subjects who suffered from a fracture will be enrolled, in addition to 150 control subjects. CT scans will be carried out for both groups (no later than 3 months for the fracture group) and BBCT-hip run,in order that the risk of fracture will be obtained. First, a transversal study will be performed, where the stratification accuracy of BBCT-hip will be assessed in terms of the ability of the predicted risk of fracture to separate fracture and control subjects. Furthermore, the control subjets will be followed up to assess BBCT-hip predictive accuracy through a longitudinal study.

Mode of Exercise and Bone Biomarkers in Older Veterans

Adults are often encouraged to exercise to maintain or improve bone health. However, there is evidence that exercise does not always lead to increases in bone mass, and exercise could lead to bone loss under certain conditions. Endurance exercise can increase bone resorption following an exercise bout, which may explain why bone does not always favorably adapt to exercise, but it is unclear if this also happens with resistance exercise. Further, it is not known how exercise training influences blood markers of bone resorption for either endurance or resistance exercise. The purpose of this study is to determine 1) if resistance exercise causes a similar increase in bone resorption as endurance exercise; and 2) if exercise training influences the increase in bone resorption following exercise for both endurance and resistance exercise.