Bone Disease

Researchers are evaluating the effects of high-intensity pulsed electromagnetic field therapy HI-PEMF in older adults with moderate to severe knee osteoarthritis OA. This randomized, double-blind clinical trial compares two treatment methods HI-PEMF applied only to the knee joint versus HI-PEMF applied both to the knee and the quadriceps muscles. The study aims to understand pain reduction and improvement in functional performance in this population, addressing common issues such as muscle weakness and frailty associated with knee OA. Participants will be randomly assigned to one of two groups. Group A will receive HI-PEMF therapy focused exclusively on the symptomatic knee for 10 minutes per session, twice weekly for 5 weeks, totaling 9 sessions. Group B will receive HI-PEMF therapy applied to both the knee and the quadriceps muscle, with each site treated for 10 minutes per session under the same schedule. Both groups will also follow a standardized, home-based exercise program involving five specific strengthening and mobility exercises performed three times per week during the 5-week treatment period. The BTL-6000 Super Inductive System device is used for all HI-PEMF treatments. During the study, participants will be assessed at the start, after the 5-week intervention, and at a 2-month follow-up. Researchers will measure changes in pain using the Numeric Analog Scale NAS, functional mobility through the Timed Up and Go TUG test, and lower-limb strength with the 5-times Sit-to-Stand 5STS test. Additional evaluations include monitoring paracetamol use, frailty, sarcopenia, and radiological OA grade. Adherence to treatment sessions and exercises will be closely followed, and safety monitored throughout the study, which lasts a total of about three months including follow-up.

The 100-Year Human Aging Study is a long-term observational research project enrolling adult participants to undergo detailed multi-system health screenings and follow them throughout their lives until death. The study aims to identify which health measurements taken at enrollment and repeatedly over time can predict overall mortality, cause-specific death, serious diseases, and functional disability. It addresses the current lack of validated longevity measures by generating data on how various physiological and cognitive functions relate to aging outcomes. Participants undergo a comprehensive clinical screening that includes tests of cardiorespiratory fitness, strength, mobility, neurocognitive performance, sensory functions, and metabolic health. Structural imaging assessments like DEXA scans, echocardiography, electrocardiography, spirometry, retinal photography, and vascular ultrasound are performed. Laboratory tests and detailed medical, social, and environmental histories are also collected. The study allows participation from single tests up to a full two-visit screening, with repeat testing encouraged to track health changes over time. Throughout the study, participants receive individualized reports with investigational estimates of biological age and predicted mortality risks, which are being evaluated against actual health outcomes. Researchers collect data continuously on mortality, disease occurrence, disability, and health behavior changes. The study involves ongoing follow-up with periodic assessments and aims to preserve all collected data for future analyses, with participant involvement potentially spanning their entire lifespan.

Researchers are studying the use of the TRUMATCH Graft Cage to repair large segmental defects in long bones such as the humerus, femur, and tibia. This observational case series includes patients aged 18 and older who have these critical-sized bone defects requiring surgical fixation. The goal is to collect data over three years to better understand the healing process, complications, and recovery outcomes associated with this device. Participants who agree to join will receive the TRUMATCH Graft Cage during surgery to repair their long bone defects. The study focuses on collecting information about healing rates, complication rates, reoperation rates, pain levels, and the time it takes to return to normal activities. Data collection will occur over two years following the procedure to evaluate early outcomes of using the graft cage. During the study, participants will be monitored regularly to track their healing progress and any complications. Researchers will assess pain scores, need for additional surgeries, and functional recovery. The study will analyze this information after three years of data collection to provide insights on the graft cages usefulness for managing complex long bone injuries. Participation involves follow-up visits and evaluations related to their surgical repair and recovery.

Researchers are evaluating TS-172 in adults with hyperphosphatemia who are receiving hemodialysis due to chronic kidney disease. This open-label, single-arm clinical study aims to assess how well TS-172 controls serum phosphorus levels in this patient group. The study is sponsored by Taisho Pharmaceutical Co., Ltd. and focuses on patients who have been on hemodialysis three times a week for at least 12 weeks. Participants will receive oral TS-172 once daily at doses ranging from 20 to 60 mg. The study monitors the achievement rate of target serum phosphorus levels by Week 8. Secondary measures include changes in serum phosphorus concentration, corrected serum calcium levels, and the serum calcium-phosphorus product up to Week 8. During the study, participants will undergo regular blood tests to measure phosphorus and calcium levels and monitor parathyroid hormone concentrations. Researchers will track changes from baseline to evaluate treatment effects. The study does not involve blinding or placebo groups. Participants will be followed from screening through Week 8 to assess safety and efficacy outcomes.

Researchers are evaluating the safety, tolerability, pharmacokinetics PK, and pharmacodynamics PD of KK8123 in adults with X-linked hypophosphatemia XLH through a Phase 12, multicenter, open-label, dose-escalation study. This first-in-human study aims to better understand how KK8123 behaves in the body and its effects on patients with this condition. The study is sponsored by Kyowa Kirin Co., Ltd. and includes an optional safety extension period. The study includes a Screening Period of up to 28 days, followed by Part 1, which is a Dose Escalation Period consisting of a planned Treatment Period and an Observation Period lasting 32 to 44 weeks. Part 2 is an optional Extension Period for additional safety evaluation. Participants receive subcutaneous doses of KK8123 at different levels, including low dose single dose, mild dose multiple doses, and high dose multiple doses, with dosing confirmed for later cohorts. The study groups include several cohorts receiving escalating doses and an extension group. Participants will undergo multiple assessments during the study, including laboratory tests for hematology and clinical chemistry, measurement of serum phosphorus levels, echocardiograms, renal ultrasounds, and monitoring of vital signs such as heart rate and blood pressure. Researchers will track treatment-emergent adverse events TEAEs and measure KK8123 drug concentrations over time. Follow-up periods last up to 44 weeks in Part 1 and up to 52 weeks in Part 2. Participants are expected to adhere to study visit schedules and complete all assessments throughout their involvement.

Researchers are evaluating the long-term safety and effectiveness of the drug TS-172 in patients with hyperphosphatemia who are undergoing hemodialysis. This Phase 3 study focuses on patients who have chronic kidney disease and have been receiving hemodialysis or hemodiafiltration three times a week for at least 12 weeks. The study is sponsored by Taisho Pharmaceutical Co., Ltd. and aims to assess the impact of TS-172 on controlling phosphate levels. Participants will receive oral TS-172 at doses ranging from 20 to 60 mg per day while continuing their prescribed phosphate binder regimen without changes in dosage during the study. The trial includes a treatment period lasting up to 52 weeks to monitor the drugs safety and efficacy in managing serum phosphorus levels within a specified range. No placebo or comparator groups are mentioned, and the study is open-label without masking. During the trial, participants will have regular assessments to monitor adverse events and serum phosphorus concentrations. The primary outcome measure is the incidence of adverse events within 26 to 52 weeks of treatment. Patients must meet specific eligibility criteria regarding their dialysis treatment, phosphate binder use, and serum phosphorus levels. The total participation duration will be at least one year from the start of treatment, with safety monitored throughout the study period.

Researchers are studying chronic pain in older adults, focusing on those with knee or hip osteoarthritis. This trial evaluates a mobile, remotely delivered behavioral intervention aimed at increasing physical activity and improving diet to reduce pain and enhance quality of life. The goal is to see if this approach can increase daily steps, reduce pain interference, lower body weight, and improve physical function over 6 months, with a follow-up maintenance phase lasting 12 months. Participants will be randomly assigned to one of two groups. The intervention group will join weekly group sessions with peers and receive individual coaching calls to encourage moving often throughout the day and adopting healthier eating habits to lose weight. They will use an activity monitor and a mobile app for feedback and goal-setting. The comparison group will receive an activity monitor and a wireless weight scale but no behavioral intervention. After 6 months, all participants enter a 12-month no-contact period to maintain their progress independently. During the study, participants will be assessed on daily steps, pain interference, body weight, physical function tests like the 30-second chair stand and gait speed at baseline, 6 months, and 18 months. Researchers will monitor changes in these areas to measure the interventions effectiveness. Participants will attend virtual testing appointments and complete questionnaires, with the total study duration being 18 months including follow-up.

This research aims to study and treat individuals with various bone and mineral disorders at the NIH Clinical Center. It provides an opportunity to collect bone specimens for research and to increase knowledge of skeletal diseases, supporting further studies in bone biology. Participants include those with both common and rare bone and mineral metabolism disorders, with evaluations tailored to each diagnosis. Participants receive standard care evaluations and treatments for their bone conditions, without experimental procedures. Assessments include medical history, physical exams, blood and urine tests, and imaging such as X-rays, CT scans, MRIs, bone densitometry, and bone scans. Bone samples may be collected during planned surgeries or through bone biopsies as part of participant evaluation. Throughout the study, participants undergo medical assessments and specimen collection at times specific to their diagnosis. Researchers analyze clinical and research specimens, including genetic and biochemical evaluations of surgical waste materials. The study also aims to create a database of participant information and biological samples to support future research. Participation duration and specific procedures vary by individual needs.

Childhood obesity is a growing public health issue worldwide and especially in Spain, where it is more prevalent in southern regions. Factors contributing to this include dietary habits, physical inactivity, socioeconomic status, and family environment. The study aims to evaluate the impact of a nutritional intervention administered by school nurses to address childhood obesity and its health consequences, including heart and musculoskeletal issues. The study compares two groups of schoolchildren aged 6 to 16. One group receives a technological intervention using podcasts, gamification, and virtual reality to promote nutrition education and healthy behaviors. The control group receives traditional brochures with nutritional information. Both groups are monitored through various measurements and biometric data collected over a 15-month period. Participants will be assessed regularly for weight, height, body composition, circumference measures, blood pressure, and adherence to the Mediterranean diet using questionnaires. Additional evaluations include a 3D avatar system for anthropometric measures. The study includes data collection at multiple timepoints from 12 weeks up to 15 months, with ongoing monitoring to assess the effectiveness of the intervention and potential health improvements.

Researchers are conducting a phase 3 trial to study TS-172, an oral drug, in patients with hyperphosphatemia who are on hemodialysis. The study is designed as randomized, placebo-controlled, and double-blind to evaluate the effect of TS-172 combined with phosphate binders. The purpose is to understand how well TS-172 controls serum phosphorus levels in this patient group. Participants will receive either TS-172 at doses of 20 to 60 mg per day or a placebo, both given by mouth. The study involves continuing the use of phosphate binders at stable doses during the trial. The treatment period lasts up to 8 weeks, during which the impact on phosphorus and calcium levels will be assessed. During the trial, participants will have their serum phosphorus, corrected calcium, and calcium-phosphorus product measured regularly, with the main focus on achieving target phosphorus levels by week 8. The study includes careful monitoring of parathyroid hormone levels and follow-up visits to ensure safety and track treatment effects. Overall participation spans the treatment period and related assessments up to 8 weeks.