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

NCT05066477 | Completed

• 1 other identifier: CALGO-OST
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Osteopenia; Osteopenia of the Elderly

Keywords

bone meal; bone mass; bone mineral density; bone mass density; salmon bone meal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Mean change in Bone Mass Density (BMD) of the lumbar spine (L1-L4) at Month 12, and Month 24.

  Baseline, 12 Months, and 24 Months

• Mean change in Bone Mass Density (BMD) of the distal forearm at Month 12, and Month 24.

  Baseline, 12 Months, and 24 Months

• Change in serum levels of markers of bone formation at Month 6, Month 12, and Month 24.

  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.

  Baseline and 24 Months

• Difference in number of Adverse Events between the study groups.

  3 Months, 6 Months, 12 Months, 18 Months, 24 Months

Study Arms (2)

CalGo (Salmon bone meal)

ACTIVE COMPARATOR

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

Maltodextrin

PLACEBO COMPARATOR

4 capsules daily of maltodextrin is taken per orally. Each capsule contains 500 mg of maltodextrin. Once daily dosing. Duration: 2 years.

Other: Placebo

Interventions

CalGo DIETARY_SUPPLEMENT

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.

CalGo (Salmon bone meal)

Placebo OTHER

Pure maltodextrin

Maltodextrin

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hofseth Biocare ASA: lead
• Møre og Romsdal Hospital Trust: collaborator

Study Sites (3)

Hofseth Biocare ASA

Ålesund, Møre og Romsdal, 6005, Norway

Location

Kristiansund Hospital

Kristiansund, Møre og Romsdal, 6508, Norway

Location

Lovisenberg Diakonale Sykehus

Oslo, 0456, Norway

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Øystein B Lian, MD, PhD

  Møre og Romsdal Hospital Trust (Helse Møre og Romsdal), Kristiansund Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: October 4, 2021
• Study Start: September 22, 2021
• Primary Completion: June 12, 2025
• Study Completion: June 12, 2025
• Last Updated: September 23, 2025

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

NO (3)