Osteomalacia

The NeuroVitD study focuses on adults with neurological disorders causing motor disabilities, such as stroke, spinal cord injury, and traumatic brain injury. Researchers aim to assess vitamin D insufficiency in these populations and evaluate the effects of vitamin D supplementation on structural and functional health parameters. The study will provide important epidemiological data to help develop vitamin D guidelines for neurological conditions, addressing a current lack of data in this area. Participants will receive one of two vitamin D supplementation plans either 50,000 I.U. weekly for 8 weeks or 25,000 I.U. weekly for 4 weeks followed by 10,000 I.U. drops weekly for an additional 4 weeks. A control group with sufficient vitamin D levels will not receive supplementation. Alongside vitamin D levels, the study will measure bone density, body composition, strength, walking speed, physical performance, pain, and biochemical markers such as calcium, parathyroid hormone, and phosphorus. Participants will be inpatients undergoing usual rehabilitation care and will be evaluated at the start and end of the study period of up to two years. Researchers will collect comprehensive data including demographic, lifestyle, and biochemical assessments, using tools like DXA scans, hand dynamometers, walking tests, and pain scales. The primary outcome is the number of participants with low vitamin D levels. Secondary outcomes include improvements in structural and functional parameters with supplementation. Safety and tolerance of vitamin D will also be monitored throughout the study.

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.

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.

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 ACCs 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.

This research aims to explore whether a womans vitamin D level on the day of her frozen embryo transfer FET affects pregnancy and delivery outcomes in women undergoing in vitro fertilization IVF in the United Arab Emirates UAE. Given the high prevalence of vitamin D deficiency in the region and mixed evidence from previous studies, this study seeks to clarify the relationship between vitamin D status and reproductive success specifically in FET cycles. Participants will be women aged 18 to 40 years with a body mass index BMI between 18 and 40 kgm undergoing FET at a UAE fertility center. Eligible women must have had their serum vitamin D levels measured within three months before FET. Those with deficient vitamin D levels below 30 ngmL are required to have received supplementation prior to FET. This is an observational cohort study with no intervention, where vitamin D levels and supplementation history are recorded. During the study, participants vitamin D levels will be measured on the day of FET, and pregnancy outcomes will be tracked, including clinical pregnancy within one month post-FET and live birth, miscarriage, and preterm birth rates up to six weeks after delivery. Clinical data and patient questionnaires will gather relevant information. The study spans from screening through pregnancy outcome follow-up, with detailed monitoring to assess the impact of vitamin D status on fertility treatment results.

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 gramsday 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.