Osteopenia is characterized by lower than normal bone density, which can increase the risk of fractures over time. Clinical trials related to osteopenia explore various treatment strategies to slow or prevent bone loss, including medication evaluatio...
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Found 81 Actively Recruiting clinical trials
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Researchers are investigating the effectiveness of the "Pontic-shield" technique in preserving the alveolar ridge after tooth extraction. This study compares this technique with two other approaches: ridge preservation using deproteinized bovine bone and a porcine collagen membrane, and no intervention after extraction (fresh socket). The trial aims to understand which method better maintains bone structure, addressing challenges in long-term dental implant success. The study is a three-arm randomized clinical trial. Participants are assigned to one of three groups: the experimental group receiving the "Pontic-shield" technique, where a 1mm thick fragment of the tooth root is left in place; the positive control group receiving ridge preservation with bovine bone and collagen membrane; and the negative control group receiving no insertion after extraction, allowing the blood clot to form naturally. A cone-beam computed tomography scan is done before extraction and again four months after to evaluate bone changes. Participants will undergo tooth extraction and assigned treatment. Their bone resorption is measured from extraction day to four months after. Satisfaction is also assessed using a visual analogue scale during the first week post-surgery. The study includes adults aged 18 to 80 who require extraction of specific teeth and agree to participate. Safety and healing are monitored throughout. Total follow-up lasts at least four months after extraction to assess outcomes.
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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.
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This research aims to evaluate the safety and early effects of vitamin K2 (menaquinone-7, MK-7) supplementation in adults aged 40 to 75 years with low bone mineral density, including osteopenia or osteoporosis. The study focuses on individuals carrying a specific "unfavorable" variant in the vitamin D receptor (VDR) gene, comparing them to those without this gene variant. The goal is to see if MK-7 supplementation improves bone health and related markers more in the variant group, who may have a reduced response to vitamin D. Participants will receive vitamin K2 (menaquinone-7) at doses of 100 to 200 micrograms per day along with vitamin D3 at 800 to 1000 IU per day for a period of 6 to 9 months. The study has two groups: one with homozygous carriers of the VDR variant and one control group without the variant. Both groups will follow the same supplementation regimen to compare outcomes related to bone health. During the study, participants will be monitored for changes in bone mineral density over 9 months, along with serum osteocalcin levels, bone turnover markers, vitamin D levels, and quality of life measures. Safety and tolerability will be assessed by recording any treatment-related adverse events. Participants will maintain stable diets and exercise routines, and genotyping will confirm their group assignment. Total participation will last up to 9 months with regular assessments.
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Researchers are evaluating the performance of an artificial intelligence software called Osteo Signal in detecting the risk of osteoporosis in adults aged 50 years and older. The study aims to determine how accurately the software can identify osteoporosis risk using chest x-ray images compared to the standard method of dual-energy x-ray absorptiometry (DXA). This observational study uses past imaging data collected from individuals who have previously undergone both chest x-rays and DXA scans. The main intervention being assessed is the Osteo Signal AI software, which analyzes chest x-rays to screen for osteoporosis risk. There are no new treatments or procedures for participants since the study is retrospective and uses existing imaging data collected within six months of each other. The study involves comparing the AI software's results against the DXA scan findings to classify bone status. Participants are not directly involved as the study uses existing medical images and records, including chest x-rays and DXA scans performed after January 2010. Researchers will analyze these images along with metadata such as age and sex. The primary outcome is the accuracy of classifying bone status as osteoporosis or non-osteoporosis. Secondary outcomes include more detailed classifications such as osteopenia and normal bone status. The study is designed to monitor the software's performance without requiring additional visits or interventions from participants.
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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.
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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.
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Researchers are evaluating the clinical performance of maxillary All-on-X full-arch implant-supported rehabilitation using a fully digital stackable guided surgery and immediate loading protocol. This retrospective study focuses on patients with terminal maxillary dentition treated with this approach, aiming to assess implant survival and peri-implant outcomes over a two-year follow-up. The study also investigates how surgical and prosthetic factors, including basal seating guide design, influence these results. Patients received a maxillary All-on-6 implant-supported complete fixed dental prosthesis planned through three-dimensional imaging and dedicated software. Stackable surgical guides were used to enable guided bone reduction when needed, followed by fully guided implant placement under local anesthesia. Implants with sufficient primary stability were immediately loaded with a screw-retained provisional fixed prosthesis on multi-unit abutments. The treatment followed a standardized surgical protocol with occlusal contacts minimized during healing. Participants are followed for at least two years with scheduled clinical and radiographic assessments at prosthesis delivery, one year, and two years. Outcome measures include implant survival at six months post-placement, peri-implant clinical parameters such as plaque index, bleeding on probing, probing depth, and marginal bone level changes assessed by standardized radiographs. The study collects complete clinical and radiographic records to evaluate success according to established criteria.
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Long bone defects (LBD) are focal losses of bone tissue in the long bones of the arms or legs, often caused by trauma, tumors, or infections. Post-traumatic defects make up the largest group and present complex treatment challenges. This international, multicenter registry aims to collect detailed information on the prevalence, treatment methods, complications, and outcomes of post-traumatic long bone defects to improve clinical knowledge and care. Patients with long bone defects will be included from multiple centers over a 3-year period, aiming to enroll at least 600 participants. The registry will record any surgical treatments used, without dictating specific therapies, allowing individualized clinical decisions. Data collection will cover preoperative, intraoperative, and follow-up details, including the bone defect characteristics and surgical findings. Participants will undergo assessments before and during surgery, with follow-up evaluations at 6 and 12 months, or 6 months after bone healing, up to 18 months. These include functional outcomes, patient quality of life, and radiological imaging. The study will monitor patient progress and outcomes to better understand treatment effects and challenges for those with post-traumatic long bone defects.
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This research aims to monitor women with gynecologic cancers who experience early menopause after having their ovaries removed. The study looks at how menopausal symptoms and bone health change over time in these patients. It also examines how platinum-based chemotherapy drugs may affect menopausal symptoms and bone loss. The goal is to identify the best timing and effective hormone therapy programs for these women and to guide osteoporosis screening and prevention strategies. This is an observational study where patients receive no specific intervention as part of the trial. Researchers will follow these women after their surgery, tracking changes in their bone mineral density and symptoms related to menopause using various scales. Patients are observed over multiple time points up to 36 months post-operation to gather comprehensive data about their health status. Participants will undergo regular assessments including bone mineral density tests and evaluations of menopausal symptoms, mood, sleep quality, and osteoporosis risk at intervals from 1 month to 3 years after surgery. The study also tracks longer-term outcomes like overall survival and progression-free survival over 5 years. This thorough monitoring helps researchers understand the effects of surgery and chemotherapy on these patients' quality of life and bone health.
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Researchers are evaluating the biomechanical effects of digitally designed subperiosteal implants made from different materials on the atrophied upper jaw bone (maxilla). These implants are considered for patients with advanced bone loss where traditional implants may not be suitable. The study aims to understand which implant material could be best suited for this condition, as there is limited evidence regarding the optimal material choice. The study compares virtual designs of subperiosteal implant frameworks made from three materials: titanium, PEEK, and PEKK. These frameworks are digitally constructed for use on the atrophied maxilla bone. A 3D image of the patient's upper jaw bone is created from a computed tomography scan and processed into a digital model. This model is used to simulate force loading between the implant parts, screws, and bone tissues to analyze biomechanical behavior. Participants will contribute by providing their computed tomography scan data that produces the 3D image of their edentulous maxilla bone. Researchers will analyze bone loss under the implants over a period of 10 to 15 years using digital simulation methods. The study is observational and does not involve direct treatment but focuses on evaluating implant framework materials and prosthetic superstructures in the digital environment. The trial includes adults aged 30 to 70 with specific bone classifications of the maxilla.
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