Postmenopausal Women

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.

This research aims to evaluate if men with prostate cancer who experience hot flashes from their androgen deprivation therapy ADT will consistently wear a smartwatch to track their health data and log hot flashes. The study focuses on comparing smartwatch data with daily surveys about hot flash experiences to better understand these symptoms. The study is conducted with patients receiving ADT who report daily hot flashes and are willing to use wearable technology for monitoring. Participants will be given an EmbracePlus smartwatch and a charging device after consent and eligibility confirmation. They will be trained to use the device, including how to log hot flashes by pressing a button on the watch. The smartwatch pairs with a smartphone app to transmit biometric data and hot flash events to a cloud server for research access. Participants will wear the watch continuously for 28 days, except for charging, and receive up to four daily surveys through text message links to report their hot flash experiences. Throughout the study, participants will be monitored by the research team who will verify data collection and device use. They will receive a check-in call and complete an end-of-study survey. Researchers will measure the duration of watch wear per day, the percentage of days with self-reported hot flash events, and how well smartwatch logs match the surveys. The total participation lasts 28 days, during which biometric data and subjective hot flash reports are collected and analyzed.

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 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.

This research aims to evaluate the effect of equol, a compound produced by gut bacteria from soy-related diets, on menopausal symptoms in women aged 40 to 60. The study hypothesizes that women who produce equol may experience milder menopausal symptoms compared to those who do not. Equol has estrogen-like activity, which is thought to influence these symptoms. Participants will consume a soy protein bar after dinner on the first day of the study. Urine samples will be collected before and after consuming the soy bar to measure equol concentration. The samples will be analyzed to assess the relationship between equol production and menopausal symptoms. During the study, participants will have their height, weight, and blood pressure measured and will complete questionnaires about their demographics, menopausal symptoms, diet, and physical activity. Urine samples will be collected on two consecutive mornings and sent for analysis. The main outcome measured is the urine equol concentration before and after soy bar consumption, helping researchers understand equols role in menopausal symptoms.

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.

Researchers are studying Canadian women who are in menopause and experiencing bothersome hot flashes and night sweats, also called vasomotor symptoms VMS. The study focuses on women whose own doctors have prescribed the drug fezolinetant as part of their usual health care. The main goal is to find out if fezolinetant improves these symptoms after 12 weeks, with additional aims to observe benefits over a full year, including better sleep and overall wellbeing. Participants will take oral tablets of fezolinetant every day for up to 52 weeks. This observational study records information about how the drug is used in real-life clinical settings, without the study team deciding on treatment. The study also gathers data on treatment satisfaction, adherence, reasons for starting or stopping the drug, and any safety concerns. Other menopausal treatments taken alongside fezolinetant are tracked as well. Women in the study will provide information through questionnaires and reports at various times during the year, including baseline and weeks 4, 12, 24, and 52. These assessments cover symptom improvement, sleep quality, treatment satisfaction, and side effects. Safety events are monitored up to 56 weeks. All participant data helps researchers understand the effects and use of fezolinetant during routine care, with no extra treatments provided by the study.

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.

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.