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Profylactic Treatment for Patients in Risk Osteoporosis

RecruitingNAAges 55 Years - 85 YearsAllMeddoc
NCT05787808 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The aim is to compare the daily intake of Calsium (Ca) + vitamin D with and without daily optimal efficacy dose (OED) of Jarlsberg on Bone Mineral Density (BMD) and bone markers (BM) to Osteopeni patients (OP). * The study population consists of OP-patients of post-menopausal women and men above 55 years of age. OP patients are defined as patients with a T-score below 0.0, but larger than -2.5. * The study will be performed as a randomized, single-blinded Norwegian multicentre trial with stratified semi-cross-over design with gender and site as stratification factors. The OP-patients included in the study will be allocated to one of the two treatment groups by block randomization with random block size between 2 and 6. * Women in post-menopausal age have a daily OED Jarlsberg of 45 gram and men in the same age interval have a daily OED of 55 gram. * The main response variable will be th

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📋 Eligibility rules (as published)
Inclusion Criteria: * Osteopeni patients (OP) of both genders above 55 years of age. OPs are defined as patients with T-score below 0.0 but larger than -2.5. Exclusion Criteria: * • Eating disorder * Known gastrointestinal disorder. * Abnormal liver or kidney function. * Diabetes mellitus type I. * Diabetes type II without sufficient control. * Suffering from verified cancer. * Under systemic treatment with corticosteroids or other immunosuppressive drugs the last 3 weeks before start of the trial treatment. * Under active antiresorptive treatment or anabolic treatment. * Participating in another clinical trial with pharmaceuticals the last six weeks before start of this trial treatment. * Known milk product allergy. * Not able to understand information. * Do not want or not able to give written consent to participate in the study.
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What it tests

  • Calsium, Vitamin D, Jarlsberg cheese
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Where

1 site
Meddoc
Skjetten, Norway
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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