Clinical Research Directory

Salivary Cytokines, MMP-8 and Dental Caries in Osteoporosis Patients

This study examines saliva samples from patients with osteoporosis. The levels of cytokines and Matrix Metalloproteinase-8 (MMP-8) enzyme in saliva will be measured. Additionally, the dental caries status of participants will be evaluated. The aim of this study is to understand the relationship between osteoporosis and oral health. Only saliva samples will be collected from participants; no treatment or medication will be administered.

TCM Formula vs. HMB in Pre-Frail Elders: Muscle Strength and Bone Status

The purpose of this study is to compare the effects of a standardized Traditional Chinese Medicine (TCM) formula versus beta-hydroxy-beta-methylbutyrate (HMB) on muscle strength and bone health in pre-frail older adults . Pre-frailty is a critical stage where functional decline may still be reversed through proper intervention. The study will enroll 90 participants aged 65 years or older who meet the criteria for pre-frailty. Participants will be randomly assigned to either the TCM group (receiving a standardized herbal powder formula) or the HMB group (receiving nutritional supplement tablets) for 24 weeks . The primary objective is to evaluate the change in handgrip strength from baseline to Week 12 . Researchers will also assess changes in skeletal muscle mass, bone mineral density, and overall physical performance . The goal is to determine if the TCM formula is an effective alternative or complementary intervention for managing geriatric frailty.

Assessment and Comparison of Osteoporosis Risk Factors After Stroke

The aim of this study is to evaluate the effects of stroke and associated clinical, functional, nutritional, and muscular factors, including handgrip strength, on bone mineral density and osteoporosis by comparing patients with subacute stroke, patients with chronic stroke, and non-stroke controls. By identifying factors associated with reduced bone mineral density and osteoporosis across these groups, the study is expected to contribute to the identification of high-risk patients and provide a basis for future research aimed at improving screening and treatment strategies. No significant risks are anticipated from participation in this study.

GRACE II (General Retrospective Analysis of Commercial Experience With AGN1 LOEP)

The study is designed as a retrospective, multicenter study for subjects previously treated with the AGN1 LOEP Kit in the proximal femur as part of standard hospital practice. This will be a non-randomized and non-blinded study. The study will collect retrospective data on the safety and performance of AGN1 LOEP of all subjects treated between September 2019 and January 2026. Subjects treated as part of an AgNovos prior protocoled study are excluded. Investigators are asked to reach out to all subjects that were previously treated with the AGN1 LOEP Kit in the proximal femur. Subject informed consent is obtained before a subject is enrolled into the study. Subjects treated but not enrolled are documented in a log with the reason why a subject did not participate. This log is kept on site. Enrolled subjects will be contacted per telephone to collect information about any fractures sustained post-AGN1 LOEP treatment.

Exercise and Fall Prevention for Fracture Reduction

According to the current guideline of the German Osteology Association (DVO), pharmacological treatment is a cornerstone of osteoporosis-related fracture prevention, effectively increasing bone mineral density and reducing fracture risk. However, particularly in older adults, falls represent a major independent fracture risk factor. Pharmacological treatment has limited effects on fall-related factors such as muscle strength, balance, mobility, and fall incidence. Physical exercise, either alone or combined with pharmacological treatment, can address these risk factors and improve fracture prevention. However, specialized osteoporosis exercise programs are not widely available, often face high demand, and require qualified instructors and suitable facilities. Older adults, particularly those with mobility limitations, face additional barriers to participation. Many prefer flexible home-based exercise, whereas fixed schedules and organizational requirements of group programs may compromise adherence and effectiveness. Currently available home-based osteoporosis exercise programs do not consistently follow the guideline "Physical Exercise for Fracture Prevention", which targets specific fracture risk determinants according to individual risk profiles. Moreover, these programs lack scientific evaluation. To address these limitations, our research group developed a home-based exercise program based on our S3 guideline "Physical Exercise for Fracture Prevention". The program differentiates between fracture risk profiles and enables accessible, flexible, and location-independent exercise. The present study will evaluate the effectiveness of this program in women with reduced bone strength and increased fall risk, a particularly relevant combination of osteoporotic fracture risk factors. Outcomes include surrogate measures of bone strength, fall risk, and mobility under real-world conditions. Research Question Is a guideline-based, fracture risk-adapted home exercise program effective in improving fracture risk determinants in women with reduced bone strength and increased fall risk when performed independently at home under real-world conditions?

Glucocorticoid-induced Osteoporosis in Patients With Chronic Inflammatory Rheumatic Diseases or Psoriasis

Glucocorticoids remain to be among the most important and most frequently used anti-inflammatory and immunosuppressive or immune-modulatory acting drugs to treat rheumatic (and other) diseases. Unfortunately, glucocorticoids also exert undesired effects, especially if higher dosages have to be given over longer periods of time. The available data describing frequency and severity of these adverse effects are fragmentary. This statement is especially true for glucocorticoid-induced osteoporosis (GIOP) in the context of chronic inflammatory rheumatic diseases or (in part) psoriasis(arthritis). The state of knowledge and scientific data, being sparse, is partly conflicting and often derived from over-aged projects or studies. Therefore, there are urgent needs to work on various current questions systematically and at the highest scientific level possible. In order to address these needs, we aim at collecting and analyzing disease- and bone-related data from patients with chronic inflammatory rheumatic diseases or psoriasis and therapy with glucocorticoids, and to build a respective GIOP-Databank. Patients will attend for diagnostics, and where necessary therapy and follow-up of GIOP, according to current guidelines. Clinical, laboratory and instrumental examination results from more than 1000 patients in the first three years of the project are planned to be documented in a prospective database.

Impact of Screening and Multicomponent Exercise on Fall Rates, Fractures, and Cardiovascular Health in Diabetes

The DIACTIVE study is a randomized controlled trial with a 5- year follow-up designed to evaluate the impact of comprehensive screening and multicomponent interventions on fall prevention, bone health, nerve function and cardiovascular outcomes in people with diabetes aged 65 years and older on the short and longer term. Diabetes significantly increases risks of falls, fractures, and cardiovascular disease, yet these areas remain underexplored in clinical research. This trial addresses these gaps with a novel, multidimensional approach. Participants undergo extensive baseline assessments, including fall risk stratification, bone mineral density measurements via DXA scans, neuropathy evaluations, and cardiovascular profiling. Based on these evaluations, participants are allocated to risk-based intervention arms. The study's centerpiece is the RYMA and ADL exercise program, a tailored cognitive-motor training regimen integrating strength, balance, and executive function exercises with music-based coordination tasks. Pharmacological treatments for osteoporosis and optimization of cardiovascular risk profiles (e.g., SGLT2 inhibitors, GLP-1 agonists) are also incorporated. Primary outcomes focus on reducing fall rates by at least 30%, improving bone density, mitigating fracture risks, enhancing nerve function, and lowering cardiovascular event rates. Secondary endpoints explore mechanisms underlying fall reduction, quality of life improvements, and adherence to interventions. Advanced methodologies such as gait analysis, seismocardiography, and magnetic resonance imaging (MRI) provide detailed insights into the intervention's effects. Follow-ups at 26 weeks, 52 weeks, 2 years, and 5 years ensure long-term efficacy evaluation. This trial is conducted at Steno Diabetes Center North and involves interdisciplinary collaboration. By addressing key complications of diabetes through integrated care, the study aims to improve patient outcomes and inform future healthcare strategies for older people with diabetes.

Surgeon-Initiated Bone Health Referral Pathway in Patients Undergoing Lower Extremity Arthroplasty

The goal of this clinical trial is to observe the impact of a surgeon-driven bone health referral pathway following lower extremity arthroplasty. The main question this study aims to answer is: 1\) What is impact of a surgeon-driven bone health referral pathway on implant-related complications and fragility fractures when compared to standard of care primary care provider referral. Researchers will compare the endocrinology referral pathway and standard of care to see if there is a difference in treatment rates, fragility fractures, and implant-related complications following lower extremity arthroplasty.

Muscle Impact of Treating Osteoporosis

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.

Generative AI Impact on Rheumatoid Arthritis Complications Diagnosis

Generative AI (GenAI) based on large language models (LLMs) is expected to improve the diagnosis and treatment of autoimmune diseases. We are studying how GenAI may affect the diagnosis of various complications of rheumatoid arthritis (RA). In a retrospective study using RA patients' EHR records, we will quantify physician adoption of GenAI predictions for RA complications and co-existing diseases. In a prospective observational study, we will assess the feasibility of using GenAI predictions as additional clinical information to help physicians make more complete diagnoses of RA complications and co-existing diseases, including complex, uncommon, or rare conditions.

Baduanjin With Resistance Training Program

The purpose of this study is to improve symptoms of Lumbar Disc Herniation (LDH) and Osteoporosis (OP) by implementing an evidence-based Baduanjin exercise to reduce pain and increase muscle strength and quality of life in Chinese patients. This study will provide new sights of exercise of elderly patients with LDH and OP for elderly patients.

Pilot Study of Secondary Causes of Osteopenia/Osteoporosis in Adults With Breast and Prostate Cancer

The investigators hypothesis is that secondary causes of bone loss are prevalent in patients with breast and prostate cancer, and those patients with secondary causes of bone loss are at higher risk for treatment related bone loss. The goals of this pilot study are to estimate the prevalence of secondary causes of osteoporosis in a cohort of patients with nonmetastatic breast and prostate cancer with osteopenia and osteoporosis.

Oklahoma Native American Women's Osteoporosis Screening Study

Native American women may be considered high risk for osteoporosis due to lifestyle factors and incidence of type 2 diabetes. The objectives of this study are to: 1) determine the prevalence of osteopenia/osteoporosis in Native American female volunteers; 2) to evaluate their rate of bone loss; 3) to assess the relationship between lifestyle factors, inflammatory mediators, and select endocrine parameters on osteoporosis risk; and 4) determine the barriers to treatment. Participants will undergo a baseline, Year 1 and Year 2 follow-up osteoporosis risk assessment. Data will be analyzed using repeated measures ANOVA and logistical regression.

AI-Generated Audiovisual Education and Osteoporosis Knowledge

This study aims to enhance osteoporosis awareness and health literacy among individuals through audiovisual digital educational content generated using the NotebookLM artificial intelligence platform, based on educational materials developed by the International Osteoporosis Foundation. In addition, the effects of these audiovisual educational materials on osteoporosis knowledge and digital health literacy will be evaluated.

Combined Anabolic Therapy

In this research study the study investigators want to learn more about the effect of two different FDA-approved medication regimens in the treatment of postmenopausal osteoporosis.

Tocotrienols and Bone Health of Postmenopausal Women

Osteoporosis (severe bone loss) is a bone disease with bone fragility and an increased chance for bone fractures. Recent studies have indicated tocotrienols (one kind of vitamin E) supplement may be good for the bone health in postmenopausal women. However, no study has ever been done the role of tocotrienols in bone health in postmenopausal women. Our long-term goal is to develop a new strategy featuring a dietary supplement (i.e., tocotrienols) for slowing down bone loss in postmenopausal women. We examined the effects of 12-week tocotrienols supplemenation on bone measurements in postmenopausal women. We plan to enroll approximately 200 women to recruit 78 qualified women into 3 groups: no tocotrienols, low tocotrienols, or high tocotrienols group. The outcome measures will be assessed at baseline, after 6 weeks, and after 12 weeks. Bone-related measurements will be recorded using blood and urine samples. Investigators will monitor the safety of subjects after 6 and after 12 weeks. Food intake, physical activity, and quality of life will be assessed at baseline and 12 weeks. All data will be analyzed statistically.

Osteoporosis & Renal Disease: Research in Primary Health Care Services

Osteoporosis, a silent and multifactorial systemic skeletal disorder, severely compromises bone strength and significantly increases the risk of fragility fractures. Despite its high prevalence (affecting \~10% of Portuguese over 50), it remains critically underdiagnosed and undertreated, with over 80% of fragility fractures occurring in untreated individuals. Chronic Kidney Disease (CKD) profoundly exacerbates bone fragility, giving rise to CKD-associated osteoporosis, a complex skeletal disorder often integrated within CKD-Mineral and Bone Disorder. This systemic dysregulation of mineral metabolism not only impairs bone quality but also actively promotes vascular calcification and significantly elevates cardiovascular disease risk, underscoring a critical kidney-bone-vascular nexus. Despite these well-established links, CKD-associated osteoporosis is similarly underdiagnosed and undertreated, partly due to diagnostic challenges related to Bone Mineral Density interpretation and therapeutic hesitancy in this complex patient population. This multi-phase observational study is designed to address the significant public health challenges posed by osteoporosis and by osteoporosis associated with CKD in Portugal, particularly among individuals aged 40 years to 90 years. The study aims to enhance understanding of disease prevalence, identify diagnostic and treatment gaps, and evaluate management trajectories, while emphasizing the intricate interrelationships among bone health, renal function, and cardiovascular risk.

Controlled Reduction of AO Spine B3 Fractures in Ankylosing Spinal Disorders Using an Inflatable Positioning Device: Technical Note and Retrospective Single-centre Case Series

Retrospective observational

A Study to Test the Efficacy, Safety and Tolerability of Romosozumab Treatment in Postmenopausal Chinese Women With Osteoporosis

The purpose of the study is to evaluate the effect of treatment with romosozumab for 6 months compared with placebo on the percent changes in bone mineral density (BMD) at the lumbar spine, at the total hip and femoral neck in postmenopausal Chinese women with osteoporosis.

Preserving Geriatric Muscle With an Osteoporosis Medication

Our goal is to demonstrate efficacy of the novel agent Denosumab to improve or preserve muscle health, strength, mobility and function in frail older adults.

Sickle Cell Disease (SCD) Bone Pain Study

A prospective study to determine how low bone mineral density and/or vertebral compression fractures associate with pain in adults with sickle cell disease

Clinical Study on a New Diagnostic Strategy for Osteoporosis and Sarcopenia in Chronic Kidney Disease Patients Based on MRI-FF

This is a single-center, observational cohort study aiming to validate the diagnostic value of MRI-FF in identifying osteoporosis and sarcopenia in patients with chronic kidney disease (CKD). A total of 868 participants, including 434 CKD patients and 434 non-CKD controls, will be enrolled at Beijing Jishuitan Hospital. All subjects will undergo MRI-FF scans of the lumbar spine and thigh to assess bone mineral density and muscle fat fraction. The primary objective is to evaluate the correlation between MRI-FF parameters and conventional diagnostic criteria for osteoporosis and sarcopenia, as well as to determine the optimal cut-off values for early detection. The study duration is from March 2026 to December 2028.

Metabolic Determinants of DXA-Measured Bone Mineral Density

This retrospective observational study will examine bone mineral density measurements and their metabolic and clinical determinants in adults aged 40 years and older. Existing medical records of approximately 300 patients who underwent dual-energy X-ray absorptiometry (DXA) of the lumbar spine and femoral neck will be reviewed. The researchers will examine the relationships between DXA measurements and available clinical and laboratory findings. Differences between lumbar spine and femoral neck T-scores, bone mineral density discordance, fracture history, and FRAX fracture risk will also be evaluated. No additional examination, laboratory test, treatment, or intervention will be performed as part of the study.

Effect of Acetylcholinesterase Inhibitors on Bone Metabolism

People with Alzheimer's disease are at an increased risk of bone fracture. Some studies have shown that those taking donepezil have a lower rate of bone fractures, but the reasons for this are unknown. The purpose of this study is to measure the effect of donepezil treatment on bone metabolism factors including bone mineral density, bone turnover markers, and bone quality. Participants in this study will have a bone density test and have blood samples collected at the baseline study visit. Participants will then be assigned to donepezil to be taken daily by mouth for 12 months. Blood samples will be collected at 6 and 12 months. A repeat bone density test will be performed at 12 months. Participants will also complete questionnaires at each study visit.