Osteoporosis

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.

Researchers are conducting the 100-Year Human Aging Study, an observational trial designed to follow participants over their lifespans to investigate which health measurements can predict mortality, serious diseases, and functional disability. The study aims to validate many longevity measures that currently lack prospective evidence by tracking physiological, cognitive, social, and environmental factors that change with aging. This research will generate important data to improve understanding of aging and longevity medicine. Participants undergo comprehensive multi-system clinical screenings including tests like cardiopulmonary exercise testing, body composition assessment by DEXA, echocardiography, electrocardiography, spirometry, neurocognitive testing, sensory assessments, metabolic testing, and detailed medical and social histories. The study allows for different levels of participation, from single tests to full two-visit screening batteries, and encourages repeat testing to capture health changes over time. During the study, participants receive individualized reports including investigational estimates of biological age and predicted cause of death. Researchers collect data on mortality, serious health events, chronic diseases, functional ability, and lifestyle changes through periodic follow-up over many years, potentially up to 100 years. This extensive data collection helps evaluate how well these measurements predict aging outcomes. All data are stored in raw form for future analysis and participants are supported with ongoing contact and opportunities for repeat assessments.

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 and effectiveness of the VCFix Spinal System as a treatment for Vertebral Compression Fractures. The study focuses on reducing pain related to vertebral fractures and improving physical function and mobility. It also ensures the absence of serious adverse events caused by the device or procedure. This clinical investigation is prospective and conducted at multiple centers, sponsored by Amber Implants B.V. The treatment involves the use of the VCFix Spinal System in a stand-alone configuration. This device allows in situ adjustment to restore vertebral height and correct spinal alignment. It features a titanium structure designed to promote natural bone healing without the use of bone cement, potentially reducing side effects. The system also stabilizes the vertebra by connecting different parts of the spine using a pedicle screw component. Participants receive this device through a surgical procedure. Participants will be involved in assessments measuring pain reduction, physical function, vertebral height restoration, spinal angles, and quality of life at various time points including discharge, 1, 3, 6, 12, and 24 months after the procedure. Safety monitoring includes tracking serious adverse device effects up to one month post-procedure and adverse events up to 24 months. The total duration of participation covers these follow-up visits to evaluate long-term outcomes and device performance.

Researchers are evaluating the effects of Poly L-lactic Acid (PLLA) biostimulator treatment on women at various menopausal stages who have moderate-to-severe cheek wrinkles. This randomized, prospective study aims to assess changes in protein expression in the skin after treatment, using punch biopsies taken at several follow-up visits compared to baseline. The study is sponsored by Galderma R&D and involves about 40 participants across two sites. Participants will receive Sculptraae, a biostimulator device, applied to both cheeks in up to three treatments spaced four weeks apart. Initially, a punch biopsy is taken on one pre-auricular cheek side at baseline. After the first and second treatments, participants may receive a third optional treatment at week 8. At 12 weeks after the last Sculptra treatment, half of the subjects will have a second punch biopsy on the opposite cheek side, with the rest receiving this biopsy at 36 weeks post-treatment. Follow-up visits occur at 24 weeks after the final treatment. During the study, participants will be monitored through physical assessments, biopsy procedures, and self-assessment questionnaires measuring satisfaction at 12, 24, and 36 weeks after treatment. Researchers will analyze protein expression changes and track participant experiences. The study includes safety and adherence monitoring throughout the treatment and follow-up period, lasting up to 36 weeks after the last Sculptra treatment.

This trial studies the effect of pollen extracts on menopausal symptoms in healthy women aged 45 to 65 years who experience moderate menopausal symptoms. It aims to compare changes in symptom severity measured by the Menopause Rating Scale (MRS) over 36 weeks among women taking Graminex Water Soluble Pollen Extract (WSPE), Graminex Lipid Soluble Pollen Extract (LSPE), or a placebo. The study is a randomized, triple-blind, placebo-controlled clinical trial sponsored by Graminex LLC. Participants will be randomly assigned to receive either WSPE standardized to 6% amino acids, LSPE standardized to 7% phytosterols, or a placebo. These dietary supplements will be taken over a 36-week period, during which menopausal symptoms will be tracked. The trial includes assessment at multiple timepoints to monitor changes in overall menopausal symptom severity as well as specific symptom domains such as somatic, psychological, and urogenital symptoms. Throughout the study, participants will complete the MRS questionnaire to rate their menopausal symptoms at baseline and at weeks 6, 12, 24, and 36. Researchers will evaluate symptom changes to understand the differences between the pollen extracts and placebo. The study also monitors sleep disturbance changes and includes safety assessments. Participation involves regular study visits and symptom assessments over the 36-week treatment period.

Researchers are evaluating how a combined program of aerobic and resistance exercises along with cognitive training affects brain function in older adults aged 60 and above. The study focuses on people who are sedentary and may or may not have cardiovascular risk factors like diabetes, high blood pressure, or high cholesterol, conditions known to impact memory and attention. This trial aims to compare the effects of physical exercise alone versus combined physical and cognitive training on thinking skills and brain health. The trial includes three groups: one group will do both cognitive and physical training, another will do only aerobic and resistance exercises, and the third group will perform stretching and toning exercises as an active control. Each group participates in three sessions per week for 46 weeks, with options to train at home or at a center. The physical exercise sessions include warm-up, moderate to vigorous aerobic activity monitored by heart rate, and resistance training, while cognitive training involves computer-based memory and attention tasks. Participants will undergo assessments at the start and after 12 months to measure changes in general cognition, processing speed, executive functions, and memory. Brain imaging and blood flow measures will also be evaluated to observe changes in brain structure and function. Throughout the study, participants will be monitored for exercise intensity and adherence. The total study duration covers 12 months, with safety and cognitive outcomes closely tracked to understand the impact of these interventions.

This research aims to understand how menopause affects the risk of cardiovascular diseases such as atherosclerosis, heart attacks, and strokes in women. It focuses on the time around menopause when estrogen production stops, which is linked to a higher risk of these conditions. The study will follow 200 women from before menopause to at least 10 years after, using advanced methods to observe changes in blood vessels, the heart, and the brain, along with microRNA analysis of blood and tissue samples. Participants will be observed over a long period with repeated assessments before menopause and at 1, 3, 5, 10, and 20 years after menopause. These assessments include invasive and non-invasive measures of vascular function, as well as monitoring changes in skeletal muscle proteins and RNA expression from muscle and blood samples. Blood pressure will also be tracked regularly during this time. Women involved in the study will undergo detailed cardiovascular and biological evaluations at various time points throughout the study. This includes tests of blood vessel function, muscle tissue analysis, and blood sample collections. The researchers will also monitor blood pressure and other health indicators to understand the long-term impact of menopause on cardiovascular health. The total participation may last over 20 years, providing extensive data on how menopause influences disease risk over time.

This research investigates how aging affects motor control, focusing on healthy elderly individuals and patients with mild cognitive impairment. Researchers aim to understand differences in upper limb motor adaptation and to develop interventions that improve motor function and cognitive abilities through multisensory rhythmic skill training. The study also uses artificial intelligence to classify grasp patterns among young adults, elderly, and those with mild cognitive impairment. Participants are assigned to one of three groups: virtual reality-based rhythmic skill training using VR headsets and controllers for 35 minutes, rhythmic skill training with visual feedback via a computer interface for 35 minutes, or an upper limb strengthening exercise program supervised by a therapist. These interventions include various exercises and sensory stimulations designed to enhance motor planning, execution, and cognitive processing. Throughout the study, participants undergo assessments at baseline, 8 weeks, and 16 weeks to measure changes in grip behavior, sensory perception, manual dexterity, and cognitive function using tests like the Mini-Mental Status Examination and Purdue pegboard test. Researchers monitor motor adaptation and cognitive improvements, with the overall goal of preserving independence and quality of life for the elderly. The study is randomized and double-blind, lasting up to 16 weeks.

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.