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

Primary Purpose

Osteopenia, Osteopenia of the Elderly

Status

Active

Phase

Not Applicable

Locations

Norway

Study Type

Interventional

Intervention

CalGo

Placebo

About this trial

This is an interventional prevention trial for Osteopenia focused on measuring bone meal, bone mass, bone mineral density, bone mass density, salmon bone meal

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.
Use of drugs known to affect bone metabolism, including:
- Glucocorticoids
- Thyroid hormones
- Hormone replacement therapy
- 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.

Sites / Locations

Kristiansund Hospital
Hofseth Biocare ASA
Lovisenberg Diakonale Sykehus

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

CalGo (Salmon bone meal)

Maltodextrin

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

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).

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).

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.

Full Information

NCT ID

NCT05066477

First Posted

September 22, 2021

Last Updated

September 25, 2023

Sponsor

Hofseth Biocare ASA

Collaborators

Møre og Romsdal Hospital Trust

1. Study Identification

Unique Protocol Identification Number

NCT05066477

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

September 22, 2021 (Actual)

Primary Completion Date

July 3, 2025 (Anticipated)

Study Completion Date

July 3, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hofseth Biocare ASA

Collaborators

Møre og Romsdal Hospital Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteopenia, Osteopenia of the Elderly

Keywords

bone meal, bone mass, bone mineral density, bone mass density, salmon bone meal

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CalGo (Salmon bone meal)

Arm Type

Active Comparator

Arm Description

Arm Title

Maltodextrin

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

CalGo

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Pure maltodextrin

Primary Outcome Measure Information:

Title

Mean change in Bone Mass Density (BMD) of the femoral neck at Month 12, and Month 24.

Description

Change in BMD of the femoral neck is assessed based on dual-energy X-ray absorptiometry T-scores.

Time Frame

Baseline, 12 Months, and 24 Months.

Secondary Outcome Measure Information:

Title

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

Description

Change in BMD of the lumbar spine segments L1-L4 is assessed based on dual-energy X-ray absorptiometry T-scores.

Time Frame

Baseline, 12 Months, and 24 Months

Title

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

Description

Change in BMD of the distal forearm (distal radius) is assessed based on dual-energy X-ray absorptiometry T-scores.

Time Frame

Baseline, 12 Months, and 24 Months

Title

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

Description

Serum markers of bone formation are analyzed in frozen serum samples from participants.

Time Frame

Baseline, 6 Months, 12 Months, and 24 Months.

Title

Change from Baseline in self-assessed quality of life on the EuroQol-5 Dimensions-3 Levels (EQ-5D-3L) instrument at Month 24.

Description

Time Frame

Baseline and 24 Months

Title

Difference in number of Adverse Events between the study groups.

Description

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).

Time Frame

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

Title

Difference in number of fractures between the two study groups.

Description

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).

Time Frame

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

Title

Difference in urine calcium in a spot urine sample between the two study groups.

Description

Amount of calcium will be measured in spot urine samples from participants.

Time Frame

Baseline, 12 Months, and 24 Months.

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Øystein B Lian, MD, PhD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kristiansund Hospital

City

Kristiansund

State/Province

Møre Og Romsdal

ZIP/Postal Code

6508

Country

Norway

Facility Name

Hofseth Biocare ASA

City

Ålesund

State/Province

Møre Og Romsdal

ZIP/Postal Code

6005

Country

Norway

Facility Name

Lovisenberg Diakonale Sykehus

City

Oslo

ZIP/Postal Code

0456

Country

Norway

12. IPD Sharing Statement

Plan to Share IPD

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

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