A Clinical Trial Investigating the Effect of Salmon Bone Meal on Bone Mass Among Osteopenic Women (NCT05066477) | Clinical Trial Compass
CompletedNot Applicable
A Clinical Trial Investigating the Effect of Salmon Bone Meal on Bone Mass Among Osteopenic Women
Norway80 participantsStarted 2021-09-22
Plain-language summary
The purpose of this study is to evaluate the efficacy of salmon bone meal in preventing bone loss among perimenopausal women with reduced bone mass density.
Who can participate
Age range50 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Female gender
* ≥ 50 years of age
* DXA T-score of \> -2.5 standard deviations, but ≤ -1 (osteopenic range)
* Steady state body weight 1 month before study commencement date
* No contraindications for intake of the interventional product, including a prior diagnosis of fish allergy.
* Familiar with the Norwegian language, both in writing and orally
Exclusion Criteria:
* A diagnosis of osteoporosis (BMD T-score ≤ -2.5 SD as diagnosed by DXA), or any previously diagnosed fragility fractures on a background of osteoporosis.
* Use of drugs known to affect bone metabolism, including:
* Glucocorticoids
* Thyroid hormones
* Hormone replacement therapy taken continuously for a duration of less than 6 months.
* Long-term heparin therapy
* Anti-convulsive drugs
* Long-term proton pump inhibitor treatment
* Lithium
* Anti-osteoporotic drugs
* Cancer therapy
* Selective estrogen receptor modulators.
* Any disease or medical condition known to affect bone tissue, including neoplasia with or without metastasis, Paget's disease of bone, Osteomalacia, or any other disease deemed relevant by the PI.
* Gastrointestinal diseases or disturbances potentially affecting absorption of nutrients, including Crohn's disease and Celiac disease.
* Hypersensitivity to ingredients in the interventional product, including fish allergy.
* Not willing to participate in the study.
* Other reasons that the PI deems it necessary to exclude the subject.
What they're measuring
1
Mean change in Bone Mass Density (BMD) of the femoral neck at Month 12, and Month 24.