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.

The 100-Year Human Aging Study is a long-term observational research project enrolling adult participants to undergo detailed multi-system health screenings and follow them throughout their lives until death. The study aims to identify which health measurements taken at enrollment and repeatedly over time can predict overall mortality, cause-specific death, serious diseases, and functional disability. It addresses the current lack of validated longevity measures by generating data on how various physiological and cognitive functions relate to aging outcomes. Participants undergo a comprehensive clinical screening that includes tests of cardiorespiratory fitness, strength, mobility, neurocognitive performance, sensory functions, and metabolic health. Structural imaging assessments like DEXA scans, echocardiography, electrocardiography, spirometry, retinal photography, and vascular ultrasound are performed. Laboratory tests and detailed medical, social, and environmental histories are also collected. The study allows participation from single tests up to a full two-visit screening, with repeat testing encouraged to track health changes over time. Throughout the study, participants receive individualized reports with investigational estimates of biological age and predicted mortality risks, which are being evaluated against actual health outcomes. Researchers collect data continuously on mortality, disease occurrence, disability, and health behavior changes. The study involves ongoing follow-up with periodic assessments and aims to preserve all collected data for future analyses, with participant involvement potentially spanning their entire lifespan.

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 and effectiveness of the VCFix Spinal System, a medical device designed to treat specific spinal fractures called vertebral compression fractures VCFs in adults aged 21 to 85 years. This study involves up to 8 hospitals in Europe and aims to assess how well the device works and how safe it is for patients with these fractures. The study compares two groups one receiving the VCFix implant with bone cement and the other without cement. Participants will receive the VCFix device implant either with or without the use of PMMA bone cement, according to their assigned study group. The device features in situ adjustment to realign vertebrae, a titanium structure allowing natural bone healing, and the potential to stabilize severe fractures through a pedicle screw component. Treatment will follow intended use guidelines, and researchers will monitor outcomes including pain reduction, function improvement, and device-related complications. During the study, participants will be assessed for changes in back pain and daily functioning at 6 months compared to before treatment. Additional measures include vertebral height restoration, spinal angle improvements, and health-related quality of life at various time points up to 24 months. Safety will be monitored through serious adverse device effects during the first month and adverse events up to two years. The total participation duration extends through follow-up assessments to evaluate both effectiveness and safety.

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.

Researchers are evaluating the effects of different pollen extracts on menopausal symptoms in healthy women aged 45 to 65 years. The study aims to compare changes in symptom severity, measured by the Menopause Rating Scale MRS, between Graminex Water Soluble Pollen Extract WSPE, Graminex Lipid Soluble Pollen Extract LSPE, and a placebo over 36 weeks. This Phase 2, randomized, triple-blind, placebo-controlled trial assesses how these extracts impact menopausal symptoms including vasomotor, psychological, and urogenital domains. Participants are randomly assigned to receive either Graminex WSPE, a water soluble pollen extract standardized to 6% amino acids Graminex LSPE, a lipid soluble pollen extract standardized to 7% phytosterols or a placebo. The intervention lasts for 36 weeks, during which participants complete the MRS assessment tool at baseline and at several points up to Week 36 to rate their menopausal symptoms. The study uses a parallel design and quadruple masking to compare the effects of these treatments. Throughout the study, participants provide symptom ratings using the MRS at baseline, Week 6, 12, 24, and 36. Researchers monitor changes in total MRS scores as well as individual symptom domains such as sleep disturbance, mood, and physical symptoms. The trial includes regular assessments to capture symptom changes over time, with safety and adherence monitored by qualified investigators. Participation will last approximately 36 weeks from baseline to the final outcome measurement.

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.