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

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05066477
• Other study ID #: CALGO-OST
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 22, 2021
• Est. completion date: July 3, 2025

Study information

• Verified date: September 2023
• Source: Hofseth Biocare ASA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Bone Diseases, Metabolic
• Osteopenia

Intervention

Dietary Supplement:
• CalGo
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.

Other:
• Placebo
Pure maltodextrin

Locations

Country	Name	City	State
Norway	Hofseth Biocare ASA	Ålesund	Møre Og Romsdal
Norway	Kristiansund Hospital	Kristiansund	Møre Og Romsdal
Norway	Lovisenberg Diakonale Sykehus	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Hofseth Biocare ASA	Møre og Romsdal Hospital Trust

Country where clinical trial is conducted

Norway, 

Outcome

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.