Skjetten

This research aims to estimate the effect of daily optimal efficacy dose (OED) of Jarlsberg cheese on bone mineral density (BMD) and bone markers in patients with osteopenia. The study focuses on post-menopausal women and men aged above 55 years who have T-scores below 0.0 but greater than -2.5. It is a randomized, single-blinded multicenter trial conducted in Norway with a stratified semi-cross-over design based on gender and study location. Participants will be randomly assigned to one of two groups: one group will receive daily calcium and vitamin D tablets plus Jarlsberg cheese at a daily dose of 45 grams for women and 55 grams for men, while the other group will receive only calcium and vitamin D tablets. After 16 weeks, all participants will receive both calcium, vitamin D, and Jarlsberg cheese. The total study duration will be 32 weeks for those initially receiving Jarlsberg and 48 weeks for those initially receiving only calcium and vitamin D. Study visits and assessments occur every 16 weeks. Throughout the study, participants will undergo bone mineral density scans, blood tests for osteocalcin and other bone markers, and diet tracking using a web or mobile app. Researchers will monitor treatment adherence, physical activity, and safety using standard toxicity criteria. Additional blood tests for biochemical variables and inflammatory markers will be collected. After completing the study, participants may continue Jarlsberg intake and will be followed up one year later with further bone density and blood testing.

Researchers are evaluating the recommended oral dose of BP-C2 in addition to hormone treatment for prostate cancer patients aged 18 to 80 years. This Phase I dose-finding study involves patients already undergoing hormonal therapy, aiming to estimate a safe and effective dose of BP-C2 using an open, multi-center design with a Response Surface Pathway (RSP) approach. The study focuses on assessing tolerability and toxicity using standardized criteria and quality of life measures. The trial includes a seven-day screening phase with clinical exams, blood tests, and prostate specific antigen (PSA) measurement to confirm eligibility. BP-C2 is given once daily by mouth at doses ranging from 0.33 to 1.67 mg/kg body weight, starting with 1.0 mg/kg. The treatment is organized into three consecutive four-week design levels, each with dose adjustments based on patients' responses and side effects measured by the CTCAE scores. Dose changes follow predefined rules to increase, decrease, or stop treatment depending on toxicity severity. Participants undergo regular monitoring every two and four weeks during each design level, including adverse event scoring (CTCAE) and quality of life questionnaires (EQ-5D-5L). After completing all treatment levels, patients have a final follow-up four weeks later to assess safety and quality of life. The main outcomes measured are maximum and total CTCAE toxicity scores over time, with secondary outcomes including quality of life index and visual analog scale scores.