NCT05066477

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Hofseth Biocare ASA · Industry
• Sex: Female
• Age: 50 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Osteopenia
• Osteopenia of the Elderly

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-09-22
• Primary completion: 2025-06-12
• Completion: 2025-06-12
• First posted: 2021-10-04
• Last updated: 2025-09-23

Locations

3 sites across 1 country: Norway