OsteopeniaNCT05066477
A Clinical Trial Investigating the Effect of Salmon Bone Meal on Bone Mass Among Osteopenic Women
A study testing CalGo in people with Osteopenia and Osteopenia of the Elderly, run by Hofseth Biocare ASA at 3 sites in Norway.
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. Read more about this study
- Who is it for?
- Ages 50 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteopenia, Osteopenia of the Elderly
- What is being tested?
- CalGo
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 3 sitesNorway
- Study dates
- 22 Sep 2021to 12 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
Norway3 sites
Hofseth Biocare ASA
Ålesund, Møre og Romsdal, 6005
Kristiansund Hospital
Kristiansund, Møre og Romsdal, 6508
Lovisenberg Diakonale Sykehus
Oslo, 0456
About this study
Official title: A Randomized, Double-blind Clinical Trial Investigating the Efficacy of Salmon Bone Meal on Bone Mineral Density Among Perimenopausal Osteopenic Women
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.
Read the 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
- Being tested
- CalGo, Placebo
- Keywords
- bone meal, bone mass, bone mineral density, bone mass density, salmon bone meal
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CalGoDietary 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.
PlaceboOther
Pure maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Change in BMD of the lumbar spine segments L1-L4 is assessed based on dual-energy X-ray absorptiometry T-scores.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: Baseline, 12 Months, and 24 Months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study start22 Sep 2021
- Primary completion12 Jun 2025
- Study completion12 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hofseth Biocare ASA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Møre og Romsdal Hospital Trust
- Responsible party
- Sponsor
- Investigators
- Øystein B Lian, MD, PhD, Principal investigator, Møre og Romsdal Hospital Trust (Helse Møre og Romsdal), Kristiansund Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05066477
- Sponsor's protocol ID
- CALGO-OST
- Status last verified
- Sep 2023
- First submitted
- 22 Sep 2021
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind Clinical Trial Investigating the Efficacy of Salmon Bone Meal on Bone Mineral Density Among Perimenopausal Osteopenic Women
- ClinicalTrials.gov ID
- NCT05066477
- Acronym / sponsor ID
- CALGO-OST
- Conditions
- Osteopenia, Osteopenia of the Elderly
- Keywords
- bone meal, bone mass, bone mineral density, bone mass density, salmon bone meal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Hofseth Biocare ASAIndustry (pharma, biotech, devices)
- Collaborators
- Møre og Romsdal Hospital Trust
- Study start
- 22 Sep 2021 (actual)
- Primary completion
- 12 Jun 2025 (actual)
- Study completion
- 12 Jun 2025 (actual)
- First posted
- 4 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CalGo (Salmon bone meal) | Active comparator | Dietary Supplement: CalGo4 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. |
| Maltodextrin | Placebo comparator | Other: Placebo4 capsules daily of maltodextrin is taken per orally. Each capsule contains 500 mg of maltodextrin. Once daily dosing. Duration: 2 years. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (17 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CalGoCalGo 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. | Dietary supplement | CalGo (Salmon bone meal) |
| PlaceboPure maltodextrin | Other | Maltodextrin |
Primary outcome
Mean change in Bone Mass Density (BMD) of the femoral neck at Month 12, and Month 24.
Time frame: Baseline, 12 Months, and 24 Months.
Change in BMD of the femoral neck is assessed based on dual-energy X-ray absorptiometry T-scores.
7 secondary outcomes
Mean change in Bone Mass Density (BMD) of the lumbar spine (L1-L4) at Month 12, and Month 24.
Time frame: Baseline, 12 Months, and 24 Months
Mean change in Bone Mass Density (BMD) of the distal forearm at Month 12, and Month 24.
Time frame: Baseline, 12 Months, and 24 Months
Change in serum levels of markers of bone formation at Month 6, Month 12, and Month 24.
Time frame: 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.
Time frame: Baseline and 24 Months
Difference in number of Adverse Events between the study groups.
Time frame: 3 Months, 6 Months, 12 Months, 18 Months, 24 Months
Difference in number of fractures between the two study groups.
Time frame: 3 Months, 6 Months, 12 Months, 18 Months, 24 Months
Difference in urine calcium in a spot urine sample between the two study groups.
Time frame: Baseline, 12 Months, and 24 Months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Øystein B Lian, MD, PhD principal investigator
Møre og Romsdal Hospital Trust (Helse Møre og Romsdal), Kristiansund Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CalGo in people with Osteopenia and Osteopenia of the Elderly, run by Hofseth Biocare ASA at 3 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in Bone Mass Density (BMD) of the femoral neck at Month 12, and Month 24. (time frame: Baseline, 12 Months, and 24 Months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.