A Clinical Trial Investigating the Effect of Salmon Bone Meal on Bone Mass Among Osteopenic Women

Study Overview
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Brief Summary
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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.

Detailed Description
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The current study is part of a larger project called the CalGo-project. The overall purpose of the study is to use bone meal from salmon to promote skeletal health. Specifically, the effect of salmon bone meal on bone mass density among perimenopausal women (age ≥ 50 years) with osteopenia is investigated over a time period of 2 years. Salmon bone meal is composed of a natural microcrystalline hydroxyapatite form of calcium and phosphorus, collagen type 2. Past literature on mammalian sources of bone meal has indicated that this form of calcium is superior in terms of preserving bone mass density compared to traditional calcium supplements. Preserving bone mass is essential to reduce the risk of future fragility fractures. Osteopenia is a condition of reduced bone mass density and bone quality which can indicate the later onset of clinical osteoporosis. Both are conditions associated with a significant risk of fragility fractures, which are a major global health burden. Bone mass density is measured using dual-energy X-ray absorptiometry. Markers of bone formation P1NP and CTX-1 will be measured in serum samples of participants. 100 potential participants will be screened for eligibility. Participants who meet the eligibility criteria will be randomized in a double-blind manner to receive 4 capsules daily of salmon bone meal enriched with Vitamin D3 per capsule.

Official Title
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A Randomized, Double-blind Clinical Trial Investigating the Efficacy of Salmon Bone Meal on Bone Mineral Density Among Perimenopausal Osteopenic Women

Conditions
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Osteopenia, Osteopenia of the Elderly

Intervention / Treatment
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* Dietary Supplement: CalGo
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CalGo (Salmon bone meal)<br>4 capsules daily of CalGo (salmon bone meal enriched with Vitamin D3) is taken per orally. Each capsule contains  500 mg of salmon bone meal (380 mg calcium, 200 mg phosphorus, 500 mg native collagen type 2), and 10 micrograms of vitamin D3 (400 IU). Once daily dosing. Duration: 2 years. | Dietary Supplement: CalGo<br>* CalGo is a natural marine collagenic bone powder from salmon. The bone powder is a 100 % microcrystalline hydroxyapatite form of calcium and phosphorus. Furthermore it contains collagen type 2 and is enriched with vitamin D3.<br>|
| Placebo Comparator: Maltodextrin<br>4 capsules daily of maltodextrin is taken per orally. Each capsule contains 500 mg of maltodextrin. Once daily dosing. Duration: 2 years. | Other: Placebo<br>* Pure maltodextrin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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. | 
| 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 | 
| 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 | 
| 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 | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bone meal, bone mass, bone mineral density, bone mass density, salmon bone meal