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Bone density loss, including osteoporosis and osteopenia, affects the strength and structure of bones, increasing the risk of fractures. Clinical trials for bone density loss explore a range of treatment evaluations aimed at slowing or reversing bone...

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Found 259 Actively Recruiting clinical trials

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Healthy Volunteer

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.

Age: 18Years - 80YearsAll GendersPhase Not Applicable
1 location
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Actively Recruiting

Researchers are studying the usefulness of 3D-printed tooth replicas combined with autotransplantation of teeth in children and young adults who need tooth transplantation. This study is designed to compare the 3D generated tooth replicas with the conventional methods to see if the new technology improves the surgical process and success of tooth transplantation. The study is led by Turku University Hospital and includes participants aged 9 to 23 years. Participants will undergo tooth autotransplantation surgery using either a 3D-printed tooth replica or a conventional procedure. Researchers will evaluate factors such as the duration of surgery and the degree of manipulation needed during the transplant procedure. They will also assess how well the transplanted tooth erupts and develops its roots over time. Participants will be followed for one year after surgery. During this time, clinical and radiological examinations will be performed to determine the health of the transplanted teeth. The main outcomes measured include the number of patients with healthy transplanted teeth at one year. This monitoring will help researchers understand the effectiveness of using 3D replicas in tooth autotransplantation.

Age: 9Years - 23YearsAll GendersPhase Not Applicable
1 location
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Actively Recruiting

Researchers are comparing the survival rates of different ceramic dental implants in adults with missing or hopeless teeth. This observational study focuses on two types of CeraRoot ceramic implants one-piece and two-piece TL models. The study aims to determine if there are significant differences in implant survival and to identify any complications associated with the procedures in these groups. The study involves patients from two dental centers in Barcelona, Spain, and Boulder, Colorado, USA. Participants will receive either one-piece or two-piece CeraRoot ceramic dental implants. These implants are specially designed for patients with metal allergies or chronic illnesses related to metal allergies. The study will follow patients for at least 12 months after enrollment to monitor implant survival and complications. During the study, researchers will collect information on implant survival rates and any complications occurring within one year after treatment. Participants will undergo dental assessments to evaluate implant status and oral health. The studys main outcome is the survival rate of the implants over 12 months or longer. This long-term follow-up helps understand the performance and safety of these ceramic dental implants in real-world clinical settings.

Age: 18Years +All Genders
2 locations
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Actively Recruiting

Healthy Volunteer

Researchers are evaluating the clinical performance of a new generation of customized CADCAM pre-fabricated root-analog dental implants in patients who have experienced tooth loss. This observational prospective cohort study aims to determine if these drilling-free implants are safe, effective, and clinically viable over a 36-month period and whether they provide better post-operative outcomes compared to traditional implant methods. The study is conducted by the University of Sao Paulo. Participants in this study have received personalized dental implants using the iDENTICAL Dental Implant System immediately after tooth extraction during a previous interventional phase. This study follows a single group of twelve patients over 36 months, monitoring the implants at 12, 24, and 36 months after prosthesis installation. The focus is on assessing implant survival, peri-implant tissue health, post-operative comfort, bone preservation, and tissue integration. During the study, participants will undergo clinical and radiographic examinations at the specified time points to measure radiographic success, changes in peri-implant soft tissues, prosthetic outcomes, and other peri-implant clinical parameters. The study requires availability for follow-up visits throughout the 36-month observation period. Safety and efficacy data will be collected to understand the long-term outcomes of these customized dental implants.

All Genders
1 location
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Actively Recruiting

Researchers are conducting a prospective, observational, multicenter study to evaluate the safety, effectiveness, and clinical performance of the TSX dental implant system in patients needing implants in the upper or lower jaw maxilla or mandible. This study involves 62 implants placed in approximately 60 patients who require dental implants to treat tooth loss, excluding those with prior implant failures or major bone grafting needs. The study aims to observe implant integration success and survival over a 2-year period. Participants will receive dental implants using the TSX dental implant system, with temporary prostheses placed either immediately during the implant surgery or within 48 hours, or between 3 to 16 weeks after implant placement. Final restorative treatments using the full range of ZimVie prosthetic systems will be completed no later than 4 months following implant surgery. All implants and restorations will be monitored yearly for 2 years. During the study, participants will attend follow-up visits yearly for 2 years to assess implant integration, survival, and changes in bone levels around the implant sites. Evaluations will include clinical examinations and imaging to measure bone regression and implant stability. Participants must agree to be evaluated at each study visit and provide informed consent. Total participation spans from implant placement surgery through the 2-year follow-up.

Age: 18Years +All Genders
2 locations
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Actively Recruiting

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.

Age: 40Years - 75YearsAll GendersPhase Not Applicable
1 location
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Actively Recruiting

Researchers are conducting a monocentric observational prospective study to assess how common vertebral fractures are among male patients aged 50 years and older who undergo chest-abdomen CT scans for reasons other than bone metabolic diseases. The study aims to use advanced imaging techniques combined with artificial intelligence to identify fractures that may otherwise be unnoticed. Participants will have their CT scans evaluated both by radiologists using automatic 3D reconstruction of the thoracic and lumbar spine and by AI software called NanoxAIHealthVCF from NANO-X IMAGING LTD. The study plans to enroll about 250 patients between March 1, 2025, and February 28, 2026. If one or more vertebral fractures are detected by either method, the patient will be referred for further evaluation in an Endocrinology Unit as part of standard care. Participants will provide clinical, body measurement, and medical history data at the time of their CT scan. The study involves only one evaluation during the CT scan visit, with no additional study visits unless a fracture is found. The main outcome measured is the number of vertebral fractures detected by the combined AI and 3D reconstruction method during the specified enrollment period. The study is observational, so no experimental treatment is given, and patient care follows usual medical practices.

Age: 50Years +MALE
1 location
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Actively Recruiting

Healthy Volunteer

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 softwares 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 softwares performance without requiring additional visits or interventions from participants.

Age: 50Years +All Genders
3 locations
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Actively Recruiting

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.

Age: 60Years - 90YearsFEMALEPhase Not Applicable
1 location
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Actively Recruiting

Researchers are evaluating a new approach to improve care coordination between hospitals and primary care for patients aged 75 or older who have suffered a hip fracture. The study focuses on osteoporosis treatment using zoledronic acid infusions combined with vitamin D and calcium supplements to prevent further fractures. The trial aims to test if ambulant nurses assisting general practitioners GPs can increase the number of patients receiving recommended annual zoledronic acid infusions over three years after their fracture. Participants receive an initial infusion of zoledronic acid 5 mg at the hospital after their femoral neck fracture and are then followed in one of two ways based on their region. In intervention regions, ambulant nurses support GPs with administering zoledronic acid yearly for three years. In control regions, patients receive usual care where GPs are responsible for follow-up and annual infusions guided by discharge summaries. The study is designed as a cluster randomized controlled trial with regions assigned to intervention or control groups. During the study, patients from both groups are asked to complete a questionnaire after one year, reporting if they received zoledronic acid as recommended. The main outcome is whether patients are offered treatment at the one-year follow-up. The trial includes safety monitoring and data collection over three years, with an estimated total of 200 patients to account for mortality. It seeks to establish practical procedures for nurse-assisted osteoporosis treatment in primary care settings to improve patient care continuity after hospital discharge.

Age: 75Years +All GendersPhase Not Applicable
1 location

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