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.

Researchers are conducting the 100-Year Human Aging Study, an observational trial designed to follow participants over their lifespans to investigate which health measurements can predict mortality, serious diseases, and functional disability. The study aims to validate many longevity measures that currently lack prospective evidence by tracking physiological, cognitive, social, and environmental factors that change with aging. This research will generate important data to improve understanding of aging and longevity medicine. Participants undergo comprehensive multi-system clinical screenings including tests like cardiopulmonary exercise testing, body composition assessment by DEXA, echocardiography, electrocardiography, spirometry, neurocognitive testing, sensory assessments, metabolic testing, and detailed medical and social histories. The study allows for different levels of participation, from single tests to full two-visit screening batteries, and encourages repeat testing to capture health changes over time. During the study, participants receive individualized reports including investigational estimates of biological age and predicted cause of death. Researchers collect data on mortality, serious health events, chronic diseases, functional ability, and lifestyle changes through periodic follow-up over many years, potentially up to 100 years. This extensive data collection helps evaluate how well these measurements predict aging outcomes. All data are stored in raw form for future analysis and participants are supported with ongoing contact and opportunities for repeat assessments.

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 cage's 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 1/2, 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 drug's 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 evaluating the safety, tolerability, and how the body processes the drug iN1011-N17 after oral administration in healthy volunteers and patients with post-herpetic neuralgia (PHN). This phase 1b study also compares the bioavailability of two salt forms of iN1011-N17 (Mesylate versus Hydrochloride) in healthy volunteers. The study is designed as a randomized, double-blind, placebo-controlled trial with multiple ascending doses to better understand the drug's effects and behavior. The study consists of three parts. In Part 1, participants receive either iN1011-N17 or placebo twice daily for 7 days using different formulations (suspension or capsules). Part 2 involves a crossover design where healthy volunteers receive single doses of each salt form in two separate periods with a washout time of at least 5 days. Part 3 includes two cohorts of healthy volunteers and PHN patients randomized to receive iN1011-N17 or placebo twice daily for 14 days. Throughout, dosing occurs approximately 12 hours apart with the final dose on the morning of the last day. Participants undergo various assessments including monitoring for adverse events, physical exams, vital signs, ECGs, cardiac telemetry, and laboratory tests from baseline through follow-up periods averaging 14 to 22 days depending on the part. Additional tests evaluate drug concentration levels, metabolism, and elimination. The study also tracks pharmacokinetic and pharmacodynamic properties to assess how the drug is absorbed, distributed, metabolized, and cleared. Participants are expected to attend all visits and comply with study requirements during the treatment and monitoring phases.

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 intervention's effectiveness. Participants will attend virtual testing appointments and complete questionnaires, with the total study duration being 18 months including follow-up.

Researchers are studying individuals with bone and mineral disorders to better understand these conditions and improve knowledge about bone biology. The study allows patients with various skeletal diseases to be evaluated and treated at the NIH Clinical Center, while also offering training opportunities for NIH trainees. The research includes collecting bone specimens from patients to support further study of bone diseases. Participants receive evaluations that include medical history reviews, physical exams, and standard tests such as blood and urine analysis, X-rays, bone densitometry, bone scans, CT scans, and MRI. Bone samples may be collected either from tissue removed during planned surgical procedures or via bone biopsy as part of the evaluation. No experimental treatments or tests are involved; all procedures are part of routine care for skeletal diseases. Throughout the study, patients undergo clinical assessments tailored to their diagnosis at specific times. Researchers collect and analyze clinical data and biological specimens, including genetic and biochemical tests on surgical waste material. The study aims to build a database containing detailed information and specimens from participants to support future research. Participation duration and specific assessments vary depending on each participant's condition and 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.