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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 78 Actively Recruiting clinical trials

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Actively Recruiting

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

Healthy Volunteer

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.

Age: 20Years - 85YearsAll GendersPhase Not Applicable
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

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 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.

Age: 18Years +MALEEarly Phase 1
1 location
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Actively Recruiting

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.

Age: 40Years - 70YearsAll Genders
1 location
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Actively Recruiting

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.

Age: 18Years +All Genders
21 locations
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Actively Recruiting

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.

Age: 18Years - 40YearsFEMALE
1 location
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Actively Recruiting

Healthy Volunteer

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.

Age: 18Years - 55YearsFEMALE
1 location

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