Osteomalacia

Researchers are studying vitamin D levels in hospitalized individuals with neurological disorders that cause motor disabilities. The goal is to gather important data to help create guidelines for vitamin D use in these populations, including people with stroke, spinal cord injury, and traumatic brain injury. The study also aims to evaluate how vitamin D supplements affect bone density, body composition, strength, walking speed, physical performance, and pain. The study is a two-year randomized, controlled trial enrolling 120 participants, including 30 controls. Participants with low vitamin D levels will receive vitamin D supplements either as 50,000 I.U. weekly for 8 weeks or 25,000 I.U. for 4 weeks followed by 10,000 I.U. drops weekly for another 4 weeks. Controls have vitamin D levels above 20 ng/ml and do not receive supplementation. Measurements include serum vitamin D and related biochemical markers, assessed at the start and end of the study. Participants will undergo various assessments such as bone density scans using DXA, strength tests with a dynamometer, walking speed tests, physical performance evaluations with the SPPB test, and pain scoring. Demographic data and lifestyle factors like exercise and smoking will also be recorded. Safety and tolerance of vitamin D supplementation will be monitored. The primary outcome is the number of participants with neurological disease and low vitamin D levels, with secondary outcomes including improvements in structural and functional parameters due to supplementation.

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 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.

Researchers are following participants with pediatric-onset hypophosphatasia (HPP), a rare bone disease that begins in childhood, to understand how the treatment asfotase alfa works over time. This observational sub-study will track patients at various sites in the United States and possibly other countries for at least five years, focusing on how the body responds to the treatment and any immune-related issues that may affect its effectiveness. All participants will receive asfotase alfa given under standard care, typically as subcutaneous injections. Younger children under 2 years old are recommended to have clinic visits about every three months until they turn two, then about every six months afterward. The study monitors biochemical, clinical, imaging (if needed), and quality of life outcomes related to HPP to understand the long-term effects of treatment. Participants will be regularly evaluated over a minimum five-year period, including assessments by their treating physicians to detect any loss of treatment effectiveness or serious immune-related side effects. Data collection will include clinical exams, laboratory tests, functional assessments, and quality of life questionnaires. The study aims to gather detailed information about treatment outcomes and safety in real-world settings over time.

Researchers are evaluating the effects of amorphous calcium carbonate (ACC) on bone mineral density (BMD) in postmenopausal women, comparing results with those from the FREEDOM substudy. This study focuses on women aged 60 to 90 years who have a BMD T-score between -4.0 and -2.5. It aims to assess ACC's impact both with and without the addition of Denosumab treatment, an osteoporosis therapy, in an open-label setting. Participants are assigned to one of two groups: the A arm includes women who meet National Health Insurance (NHI) criteria for Denosumab and receive 5 ACC tablets daily plus a 60 mg Denosumab injection every 6 months; the B arm includes women who do not meet NHI criteria or prefer not to receive Denosumab and take 5 ACC tablets daily only. All participants with certain vitamin D levels receive daily vitamin D3 supplements. The study spans 7 clinic visits over 24 months, including screening, treatment start, and follow-up visits. During visits, researchers perform BMD assessments and blood draws at baseline and months 1, 6, 12, and 24. They monitor changes in lumbar spine BMD as the primary outcome, along with overall BMD and bone turnover markers over 2 years. Participants are expected to comply with vitamin D intake limits and complete study procedures, allowing researchers to evaluate the effects of ACC with or without Denosumab on bone health.

Researchers are studying men with metastatic castration-sensitive prostate cancer to see if taking oral acetate can increase the amount of a gut bacterium called Akkermansia muciniphila. The trial aims to confirm this increase compared to standard care and to assess how well patients tolerate oral acetate. The study also explores whether higher levels of this bacterium relate to better metabolic health and bone strength. This is an early phase 1 clinical trial sponsored by Western University. Participants are randomly assigned to one of two groups. One group takes an apple cider vinegar caplet daily, containing 143 mg with 36% acetic acid, for three months. The other group receives standard care without supplementation. The study includes follow-up periods lasting up to six months to monitor changes and side effects. Throughout the study, stool samples will be collected at multiple time points to measure Akkermansia muciniphila levels. Researchers will also evaluate various metabolic markers such as blood sugar, cholesterol, and insulin resistance, plus bone health indicators. Side effects and tolerability will be checked after three months. Participants are monitored over six months to assess both primary and secondary outcomes related to metabolism and bone health.

Researchers are investigating the effects of sweet almonds on healing femur and tibia shaft fractures compared to routine vitamin D3 supplements. This study addresses the need for an affordable and safe alternative to bone-strengthening drugs, which often cause side effects and are costly. The trial focuses on patients with vitamin D insufficiency or deficiency, assessing the potential of almonds to improve bone healing and vitamin D levels in the blood. The trial is a single-center, open-label, crossover randomized controlled study involving 136 participants aged 18 to 55 with trauma-related femur and tibia shaft fractures. Participants are divided into two groups based on their vitamin D levels and receive treatments including daily whole almonds (5 grams/day) and weekly oral vitamin D3 (200,000 units) in various sequences with washout periods. Group 1 includes vitamin D insufficient patients receiving almonds and vitamin D3 in a crossover design, while Group 2 includes vitamin D deficient patients receiving vitamin D3 alone, almonds alone, or a combination followed by crossover treatments. Participants undergo follow-up visits at 4 and 13 weeks post-treatment, where fracture healing is monitored through routine X-rays and Radiological Union Score for Tibial fractures (RUST). Safety is closely assessed, with adverse events recorded and managed according to international guidelines. The study also tracks treatment adherence with daily diaries and compares costs and changes in blood vitamin D levels. Patients may withdraw at any time without losing their rights, and the study will be completed within 24 months including a close-out period.

Researchers are evaluating the link between vitamin D deficiency, postural stability, and neuromuscular control in adults aged 20 to 40 years. This observational study compares individuals with vitamin D deficiency to healthy controls to better understand how vitamin D status affects neuromuscular responses and balance. Participants are divided into two groups based on routine clinical test results for vitamin D levels. Those with vitamin D deficiency and those with normal vitamin D status both undergo a single session of non-invasive assessments. These include surface electromyography to measure muscle activity and tests of postural stability during various standing tasks, including single-leg and double-leg stance with and without vibration stimulation. During the single assessment session, researchers will record muscle activation and postural stability parameters under different conditions. They will analyze neuromuscular reflexes and how loading and vibration influence balance. The study aims to provide insights for future rehabilitation and balance training strategies. Participation involves no invasive procedures, medications, or additional blood tests, and results from prior routine labs are used to determine vitamin D status.

This research aims to understand the relationship between vitamin D levels, bone metabolism, and obesity in children aged 3 to 15 years who have experienced low-energy trauma. The study compares children with confirmed fractures to those with similar trauma but no fractures to explore factors that may contribute to bone fragility and fracture risk. Participants are divided into two groups: children with radiologically confirmed low-energy fractures and children with low-energy trauma but no fractures. Blood samples are collected within seven days of trauma to measure markers such as 25-hydroxyvitamin D, parathyroid hormone, alkaline phosphatase, calcium, and phosphate. Dietary calcium intake and body measurements are also recorded to evaluate nutritional and metabolic status. Children will undergo baseline assessments including body mass index measurement and a dietary questionnaire. Researchers analyze blood markers and calculate a composite bone risk score to identify factors linked to fracture risk. The study uses statistical methods to compare groups and assess the association between bone markers and fractures, aiming to improve understanding of pediatric bone health and inform prevention strategies.

Researchers are investigating the relationship between calcification characteristics seen on Computed Tomography Coronary Angiography (CTCA) and the outcomes of Percutaneous Coronary Intervention (PCI) in patients with chronic total occlusion (CTO) of the coronary artery. This observational study focuses on patients who underwent CTO PCI attempts and had CTCA scans at the study center within the last five years. The study aims to understand how calcification affects the success of PCI procedures and the use of calcium modification tools. The study involves reviewing medical records and imaging of patients who had both CTO PCI attempts and CTCA. Characteristics of calcification such as location, density measured in Hounsfield units, and quantity in the CTO will be analyzed and correlated with PCI success or failure. The study will also assess how calcium modification tools were used during PCI and their relationship to the severity of calcification. Statistical analyses will compare demographic and procedural data with calcification features and PCI outcomes. Participants will have their CTCA images and PCI reports reviewed retrospectively after providing consent through mailed forms. Researchers will analyze baseline patient data, calcification details, and procedural results. The main outcome measure is the correlation between calcification characteristics and PCI success or failure within 24 hours. Secondary measures include evaluating the role of calcium modifying tools relative to calcification severity. Participation involves no new treatment or intervention and is based on existing clinical data collected over the past five years.