Osteopenia Clinical Trial
Official title:
A Randomized, Double-blind Clinical Trial Investigating the Efficacy of Salmon Bone Meal on Bone Mineral Density Among Perimenopausal Osteopenic Women
Verified date | September 2023 |
Source | Hofseth Biocare ASA |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 80 |
Est. completion date | July 3, 2025 |
Est. primary completion date | July 3, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 50 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Norway | Hofseth Biocare ASA | Ålesund | Møre Og Romsdal |
Norway | Kristiansund Hospital | Kristiansund | Møre Og Romsdal |
Norway | Lovisenberg Diakonale Sykehus | Oslo |
Lead Sponsor | Collaborator |
---|---|
Hofseth Biocare ASA | Møre og Romsdal Hospital Trust |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean change in Bone Mass Density (BMD) of the femoral neck at Month 12, and Month 24. | Change in BMD of the femoral neck is assessed based on dual-energy X-ray absorptiometry T-scores. | Baseline, 12 Months, and 24 Months. | |
Secondary | Mean change in Bone Mass Density (BMD) of the lumbar spine (L1-L4) at Month 12, and Month 24. | Change in BMD of the lumbar spine segments L1-L4 is assessed based on dual-energy X-ray absorptiometry T-scores. | Baseline, 12 Months, and 24 Months | |
Secondary | Mean change in Bone Mass Density (BMD) of the distal forearm at Month 12, and Month 24. | Change in BMD of the distal forearm (distal radius) is assessed based on dual-energy X-ray absorptiometry T-scores. | Baseline, 12 Months, and 24 Months | |
Secondary | Change in serum levels of markers of bone formation at Month 6, Month 12, and Month 24. | Serum markers of bone formation are analyzed in frozen serum samples from participants. | Baseline, 6 Months, 12 Months, and 24 Months. | |
Secondary | Change from Baseline in self-assessed quality of life on the EuroQol-5 Dimensions-3 Levels (EQ-5D-3L) instrument at Month 24. | 5Q-5D-3L is a standardized instrument used to measure generic quality of life based on five distinct dimensions. EQ-5D-3L contains two parts. The first part contains five questions that the individual must answer and includes mobility (walking), self-care, usual activities, pain/discomfort, and anxiety/depression. For each item, there are three possible answers. Results are reported as a five-digit number ranging from 11111 (best health status) to 33333 (worst health status). Several methods exist for analysing these number profiles, and it is possible to convert the number profile into an index number. The second part is the EQ-VAS, where the patient self-assesses their overall health on a visual analogue scale (VAS), with 100 indicating the best health status. | Baseline and 24 Months | |
Secondary | Difference in number of Adverse Events between the study groups. | To assess whether there is a statistically significant difference in the number of adverse events between the two study groups (CalGo [Salmon Bone Meal] and Placebo). | 3 Months, 6 Months, 12 Months, 18 Months, 24 Months | |
Secondary | Difference in number of fractures between the two study groups. | To assess whether there is a statistically significant difference in the number of fractures between the two study groups (CalGo [Salmon Bone Meal] and Placebo). | 3 Months, 6 Months, 12 Months, 18 Months, 24 Months | |
Secondary | Difference in urine calcium in a spot urine sample between the two study groups. | Amount of calcium will be measured in spot urine samples from participants. | Baseline, 12 Months, and 24 Months. |
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