Osteopenia

17

Review clinical trials related to Osteopenia. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

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.

Participants needed: 200
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Kanuni Sultan Suleyman Training and Research HospitalUpdated: Jun 30, 2026Locations: 1
Eligibility criteria

Age 18 years or older [+5]

Age younger than 18 years [+6]

Status: Recruiting

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.

Participants needed: 120
Trial details
Age: 40+Biological sex: AllType: ObservationalSponsor: Istituto Ortopedico RizzoliUpdated: May 28, 2026Locations: 2
Eligibility criteria

Healthy patients (at risk and undergoing periodic follow-up and/or attending out... [+4]

Hematopoietic system disorders (hemolytic, aplastic, and neoplastic anemias) [+8]

Status: Recruiting

Routine Validation and Reproducibility Testing of Laboratory Assays and Research Techniques Used for Endocrine, Cardiometabolic, and Musculoskeletal Disorder Research (VALD)

The purpose of this research study is to validate (check the accuracy of) laboratory assays, intravenous catheter insertion, and equipment or devices and their reproducibility, which is necessary to perform high quality research on chronic diseases, nutrition, and metabolism (the process by which a substance is handled in the body) at the University of Missouri. As technology changes and uses new testing methods, it is necessary to compare results from old tests, equipment and devices and new tests, equipment, or devices and the reproducibility of these measurements to make sure the results are accurate. Reproducibility means performing the same test more than once to see if the same results can be achieved each time. This study will look at the validation and reproducibility of tests and laboratory assays in participants who are healthy or affected by relevant endocrine, cardiometabolic, and musculoskeletal disorders.

Participants needed: 100
Trial details
Age: 18-100Biological sex: AllType: ObservationalSponsor: Bettina MittendorferUpdated: May 7, 2026Locations: 1
Eligibility criteria

≥18 and ≤100 years of age [+1]

<18 and >100 years of age [+7]

Status: Not yet recruiting

Food Trial Evaluating Fecal Abundance of SBD111 With Once-Daily Versus Twice-Daily Administration in Healthy Adults

The purpose of this study is to determine whether a modified formulation and daily intake schedule of SBD111 results in similar levels of probiotic microbes in the gut compared with the currently used formulation. SBD111 is a food made of probiotic microbes (bacteria and yeast) and prebiotic dietary fibers (a form of fiber obtained from diet). SBD111 is a medical food used for the dietary management of postmenopausal bone loss.SBD111 was previously found to be safe and well tolerated in a human clinical safety study and a clinical efficacy study. Study participation will include a screening virtual visit, periodic remote questionnaires and check-in calls, and three at-home stool swab sample collections. Eligible participants will be assigned to one of two SBD111 study groups evaluating different formulations and dosing schedules. Each day for a 28-day period, they will take (i) two capsules once daily or (ii) two capsules twice daily (morning and evening), depending on the study group assigned. Investigators will collect demographic information and will ask questions related to dietary intake, bowel habits, and health history. Upon enrollment into the study, participants will receive six at-home stool sample collection kits, two each for baseline, Week 1, and Week 4 analysis. Samples will be collected at home and mailed to a Sōlaria Biō for analysis of the bacterial community that lives in the intestine (the gut microbiome). During the study, participants will also be asked to complete brief questionnaires related to gastrointestinal symptoms, cognitive function, well-being, and sleep. On days 7 and 28 of the study, they will be asked to complete a brief adherence questionnaire and discuss any adverse (negative) events. All participants will receive compensation in the form of gift cards for completing study procedures and returning stool samples. Participants will receive a $50.00 gift card after completing the Week 1 study procedures and after receipt of the mailed baseline and Day 7 stool swab samples. Participants will receive a $150.00 gift card after completing the Week 4 study procedures and after receipt of the mailed Week 4 stool swab sample.

Participants needed: 80
Trial details
Age: 35+Biological sex: AllType: InterventionalSponsor: Solarea Bio, IncUpdated: Apr 20, 2026
Eligibility criteria

Stated availability throughout entire study period and willingness to fulfill al... [+4]

• Are currently taking probiotic or prebiotic supplements or have taken them in... [+21]

Status: Recruiting

Veverimer to Decrease Net Acid Excretion and Bone Resorption in Adults With Osteopenia

The goal of this clinical trial is to learn if veverimer will reduce urinary net acid excretion leading to reduced bone resorption in healthy adults with osteopenia. The main questions it aims to answer are: * How much does each dose of veverimer (vs. placebo) reduce 24-hr urinary net acid excretion. * Describe the safety of veverimer based on changes in serum bicarbonate and potassium. * Assess the changes in bone resorption. * Assess the changes in bone formation. * Explore the effect of veverimer on physical performance. Participants will: * Take veverimer or placebo every day or every other day for 8 weeks * Visit the clinic a total of 8 times (including screening) for checkups and testing * Keep a medication diary tracking each day they take the study drug

Participants needed: 60
Trial details
Phase: Phase 1Age: 50+Biological sex: AllType: InterventionalSponsor: Tufts Medical CenterUpdated: Apr 6, 2026Locations: 1
Eligibility criteria

Community dwelling adults age 50 years and older (approximately equal numbers of... [+8]

Normal BMD T-scores at all spine and hip sites, osteoporosis based on BMD T-scor... [+15]

Status: Recruiting

Resistance Training and Rapamycin to Enhance Bone Formation in Postmenopausal Women

The aim of the present clinical trial is to examine the effects of everolimus, resistance training, or their combination on bone and muscle health formation in elderly women aged 60-75 years. The main questions it aims to answer are: Can rapamycin's analog (Everolimus), resistance training, or their combination, enhance bone formation and muscle functions in elderly women compared to non-treatment controls. Participants will be randomized 1:1:1:1 to one of the following treatment regimens: * Oral everolimus 5 mg once a week. * Oral placebo once a week. * Oral everolimus 5 mg once a week plus resistance training RT 1 hour, 3 times weekly. * Oral placebo once a week plus resistance training RT 1 hour, 3 times weekly. During the study there will be a total of 5-7 visits, where the participants will undergo the following: * Blood samles * DXA-, HRpQCT- (only Odense Universitetshospital) and MRI-scans * Muscle- and bone biopsies * Quality of life questionnaires * Testing of muscle funtion * Metabolic studies of muscle and bone protein turnover using labelling with deuturated water

Participants needed: 148
Trial details
Phase: Phase 2Age: 60-75Biological sex: FemaleType: InterventionalSponsor: Odense University HospitalUpdated: Apr 6, 2026Locations: 2
Eligibility criteria

Women aged 60-75 years old, any ethnicity. [+2]

Osteoporosis and fracture history [+22]

Status: Recruiting

REMS25: Study on the Use of REMS Technology in Diseases Commonly Associated With Reduced Bone Mineral Density (BMD)

This study evaluates bone mineral density (BMD) in pediatric patients aged 5-18 years with conditions negatively affecting bone health, using REMS (Radiofrequency Echographic Multi Spectrometry), a non-invasive and radiation-free ultrasound technology. Bone health is crucial during childhood, when peak bone mass develops, and reduced BMD is associated with increased fracture risk. DXA is the current reference method but has limitations in children, including radiation exposure and growth-related measurement issues. REMS has been validated in adults and shows promise in pediatrics, despite the lack of reference values. The study is a single-center, national, non-profit interventional study lasting about 12 months. Participants will undergo REMS BMD measurement, clinical history collection, and assessment of anthropometric and pubertal parameters, with prior DXA data collected when available. The primary aim is to describe BMD values measured by REMS in pediatric osteoporosis, with secondary aims including subgroup analyses and comparison with DXA. A sample of 100 patients is planned. Statistical analyses will assess BMD distributions, correlations with clinical variables, and agreement between REMS and DXA using correlation coefficients and Bland-Altman analysis.

Participants needed: 100
Trial details
Age: 5-18Biological sex: AllType: InterventionalSponsor: Meyer Children's Hospital IRCCSUpdated: Feb 17, 2026Locations: 1
Eligibility criteria

Written informed consent from adult patients or parents/legal guardians [+3]

Status: Recruiting

Clinical Study to Estimate Bone Mineral Density 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. 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.

Participants needed: 350
Trial details
Age: 21-55Biological sex: AllType: InterventionalSponsor: POROUS GmbHUpdated: Nov 20, 2025Locations: 2
Eligibility criteria

Female or male individuals aged 21 to and including 55 years. [+1]

Presence of diseases that rule out valid measurements with the DXA and POROUS R4... [+5]

Status: Recruiting

Zoledronic Acid for the Prevention of TDF-sparing ART-induced Bone Mass Density Loss in Treatment-naive HIV Positive Individuals

The goal of this clinical trial is to learn if zolendric acid can prevent the anticipated deterioration of bone mass after antiviral treatment initiation for people that were recently diagnosed with HIV. The main questions it aims to answer are: 1. Is bone mass deterioration is significant even with the new medication currently used to treat HIV? 2. Can one dose of Zolendric acid protect from deterioration of bone mass. Researchers will compare one dose of zolendric acid to follow-up only Participant will: 1. Provide blood samples for bone markers before antiviral treatment initiation and at 6M,12M,24M and 48M after treatment initiation 2. Perform DXA scan soon after antiviral treatment initiation and after 12M ,24 M and 48 months 3. Half of the patients with moderate reduction in bone mass will be treated with one dose of zolendric acid in the clinical trial, the other participants will be followed without intervention. 4. Patients with substantial osteoporosis will be treated according to standard of care by their HMO, but will continue followup in the study.

Participants needed: 110
Trial details
Phase: Phase 4Age: 18+Biological sex: AllType: InterventionalSponsor: Hadassah Medical OrganizationUpdated: Sep 18, 2025Locations: 3
Eligibility criteria

Adults over age of 18 years old of any gender, social, religious or racial backg... [+1]

Women who are pregnant, lactating or those who plan to become pregnant within th... [+3]

Status: Not yet recruiting

Brief Title: The Role of Nutrition in the Rehabilitation of Patients With Eating Disorders After a Vascular Stroke.

Brief Summary: The main objective of this thesis is to investigate the role of nutrition - specifically the administration of protein supplements (single dose and double dose) - in the rehabilitation of stroke patients with low albumin levels in relation to sarcopenia, osteopenia and functional recovery indices. The study will follow a randomized controlled trial design, incorporating clinical observation, analysis of biochemical markers, and assessment of physical and functional parameters. Participants will be randomly assigned to one of the three groups: (1) Group 1, receiving no protein supplementation (control group), (2) Group 2, receiving a single dose of protein supplement and (3) Group 3, receiving a double dose of protein supplement. The intervention will last for at least six weeks or until the biochemical markers of albumin normalize and the patient resumes regular oral intake. Biochemical assessment with be conducted through regular nutritional evaluations including measurement of serum albumin, prealbumin, C - reactive protein, creatinine, blood glucose and glycosylated hemoglobin (HbA1c), urea, electrolytes, urine albumin and additional inflammatory markers. Bone density will be assessed using DEXA, MBSR and hip measurements to determine the potential improvements resulting from the intervention. Muscle mass will be evaluated using whole - body DEXA analysis, while muscle strength and mobility will be assessed through grip strength tests and fine gait assessments. Functional recovery will be evaluated usings standardized tools for activities of daily living (Barthel Index), mental state (Geriatric Depression Scale) and quality of life (SF - 36), as well as mobility and walking tests such as the Timed Up and Go Test and 6 - Minute Walk Test. The collected data will be analyzed using appropriate statistical tools, including comparison models (ANOVA, Mann - Whitney U test) and correlation models (Pearson - Spearman). This research is expected to enhance theoretical knowledge regarding the relationship between nutrition, biochemical markers and rehabilitation outcomes in stroke patients with hypoalbuminemia. More specifically, it aims to explore the underlying mechanisms through which nutrition affects recovery - a field that remains unexplored. Additionally, the anticipated finding may contribute to the development of clinical guidelines and therapeutic approaches for the nutritional management of patients with low albumin levels, promoting personalized nutritional strategies that support effective post - stroke rehabilitation.

Participants needed: 100
Trial details
Age: 18-85Biological sex: AllType: InterventionalSponsor: University of IoanninaUpdated: May 8, 2025Locations: 1
Eligibility criteria

Age range: Adults aged 18 to 85 years [+4]

Severe infections or serious cardiopulmonary conditions: Patients with severe in... [+3]

Status: Recruiting

Effects of High-Intensity Interval Training on Bone Health in Hong Kong Older Women

Osteoporosis is an age-related disease, characterized by a decreased bone mass and an increased risk of fragility fractures. Osteoporosis leads to increasing mortality, disabilities, morbidity of chronic pain, and the cost of health and social care, as well as decreasing the quality of life from reduced independence and hindered physical, mental, and social well-being. A recent review and meta-analysis, investigating the association between physical activity and osteoporosis prevention in elderly people, indicated that the traditional exercise interventions (i.e., resistance training) were undertaken for 60+ mins, 2-3 times/week for 7+ months. However, participation rates remain low in these exercise programs among older adults, in part due to a need for specialized equipment and correct techniques to prevent injury. In addition, low motivation and associated compliance with such conventional exercise is problematic among older adults. Considering there is little evidence of HIIT benefits related to older women with osteopenia, the current study aims to evaluate the effectiveness of a 24-week HIIT intervention on bone mineral density, bone turnover markers and other health-related outcomes among Hong Kong Chinese older women.

Participants needed: 48
Trial details
Age: 60-74Biological sex: FemaleType: InterventionalSponsor: Hong Kong Baptist UniversityUpdated: Mar 21, 2025Locations: 1
Eligibility criteria

• 60 to 74 years at the start date of the project [+6]

• Severe chronic disease restricting high-intensity exercise [+5]

Status: Recruiting

A Pilot Study of Vitamin K2 (Menaquinone-7, Soloways ™) in Patients With Osteopenia/Osteoporosis Carrying a VDR Gene Variant

This pilot, genotype-stratified clinical trial aims to evaluate the safety and preliminary efficacy of vitamin K2 (menaquinone-7, MK-7) supplementation in patients with low bone mineral density (osteopenia or osteoporosis) who carry a specific "unfavorable" variant in the vitamin D receptor (VDR) gene (e.g., BsmI or ApaI polymorphisms). The trial will compare improvements in bone health and related biomarkers between two cohorts: (1) homozygous carriers of the VDR variant and (2) non-variant carriers (wild-type). Investigators hypothesize that MK-7 supplementation will lead to greater improvements in bone mineral density (BMD) and bone turnover markers in the homozygous variant group due to their potentially reduced baseline response to vitamin D signaling.

Participants needed: 40
Trial details
Age: 40-75Biological sex: AllType: InterventionalSponsor: S.LAB (SOLOWAYS)Updated: Mar 17, 2025Locations: 1
Eligibility criteria

Adults aged 40-75 years with a confirmed DXA-based diagnosis of osteopenia or os... [+3]

Current or recent (last 3 months) use of high-dose bisphosphonates, anabolic age... [+3]

Status: Recruiting

Effect of Manual Therapy on Low Back Pain in Osteopenic Postmenopausal Women

The purpose of this study is to determine the effect of manual therapy on low back pain in osteopenic postmenopausal women.

Participants needed: 40
Trial details
Age: 50-60Biological sex: FemaleType: InterventionalSponsor: Cairo UniversityUpdated: Nov 12, 2024Locations: 1
Eligibility criteria

Ambulatory, sedentary, non-smoking women having natural menopause at least 1 yea... [+4]

Osteoporosis. [+6]

Status: Recruiting

Physical Activity Guarantees Bone Density.

Bone tissue is crucial for overall health and quality of life, but it undergoes constant internal remodeling, leading to osteoporosis, a widespread bone disease. Regular physical activity can improve bone mineral density (BMD) and prevent osteoporosis. Studies have shown that premenopausal women with regular physical activity have greater BMD. Diagnosing bone resorption is essential, and dual-energy X-ray absorptiometry tests (DXA) and circulating microRNAs (miRNAs) may offer more prognostic potential than conventional markers. The gut microbiome may also regulate bone metabolism, with metabolites like trimethylamine N-oxide (TMAO) playing a role. A project aims to promote systematic physical activity to improve BMD and well-being, support societal mobilization, and conduct preventive examinations for osteoporosis risk. Implementing systematic prevention is important not only for health but also for reducing social and financial costs associated with osteoporosis and associated fractures.

Participants needed: 300
Trial details
Age: 50+Biological sex: FemaleType: InterventionalSponsor: Poznan University of Physical EducationUpdated: Oct 10, 2024Locations: 1
Eligibility criteria

Not listed

Status: Recruiting

Skeletal Effects of Type 1 Diabetes on Low-Trauma Fracture Risk

Patients with Type 1 Diabetes Mellitus (T1DM) have a higher risk of low-trauma (osteoporotic) fracture that is 7-12 times higher than non-diabetics. The bone density of people with Type 1 Diabetes is higher at the time of fracture than in non-diabetics. This suggests the presence of underlying bone tissue mechanical defects. The potential benefits to participants would be knowledge gained about their bone density and the results of laboratory tests. On a wider scale, there may be general benefits to society because the knowledge gained from this study may help better understand the effects of diabetes on bone health

Participants needed: 80
Trial details
Age: 50+Biological sex: FemaleType: ObservationalSponsor: Creighton UniversityUpdated: Sep 25, 2024Locations: 1
Eligibility criteria

No chronic disease diagnoses that may affect bone, as confirmed by the PI. [+10]

Women who have had Type 1 diabetes for less than 10 years. [+3]

Status: Recruiting

The Impact of Hormonal Contraceptive Use and Lifestyle Factors on Fracture Risk and Bone Quality in Young Female Adults

The study on hand is based on a cross-sectional design and aims to acquire 1) descriptive data on the physical state and health condition of female soldiers in the German armed forces. 2) a possible influence of different contraceptive methods as well as physical activity, body composition, strength, nutrition, and hemoglobin levels on bone health should be investigated.

Participants needed: 150
Trial details
Age: 18-35Biological sex: FemaleType: ObservationalSponsor: Bundeswehr University MunichUpdated: Sep 23, 2024Locations: 1
Eligibility criteria

18 - 35 years [+4]

for the bioelectrical impedance: electronic implants like defibrillator, pregnan...

Status: Not yet recruiting

Menier's Disease - Bone Density Study

Meniere's disease is a progressive and debilitating inner ear disease characterised by vertigo and hearing loss. Several studies have linked Menierws disease with lower bone density and lower vitamin D levels. In the current prospective study definite Meniere's patients will be followed over a period of 2 year, during which repetitive measurements of bone density, vitamin D plasma levels, blood pressure as well as hearing and vestibular tests will be made. Results will be compared to healthy controls.

Participants needed: 60
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: HaEmek Medical Center, IsraelUpdated: Aug 3, 2022
Eligibility criteria

Definite Meniere's disease

hyperthyroidism [+19]