Clinical trial NCT05066477: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Osteopenia
Osteopenia of the Elderly
Keywords: bone meal
bone mass
bone mineral density
bone mass density
salmon bone meal
Lead sponsor: Hofseth Biocare ASA
Sponsor class: INDUSTRY
Collaborators: name: Møre og Romsdal Hospital Trust
First posted: 2021-10-04
Enrollment: 80
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Mean change in Bone Mass Density (BMD) of the femoral neck at Month 12, and Month 24.
timeFrame: Baseline, 12 Months, and 24 Months.
Secondary outcomes:
measure: Mean change in Bone Mass Density (BMD) of the lumbar spine (L1-L4) at Month 12, and Month 24.
timeFrame: Baseline, 12 Months, and 24 Months
measure: Mean change in Bone Mass Density (BMD) of the distal forearm at Month 12, and Month 24.
timeFrame: Baseline, 12 Months, and 24 Months
measure: Change in serum levels of markers of bone formation at Month 6, Month 12, and Month 24.
timeFrame: Baseline, 6 Months, 12 Months, and 24 Months.
measure: Change from Baseline in self-assessed quality of life on the EuroQol-5 Dimensions-3 Levels (EQ-5D-3L) instrument at Month 24.
timeFrame: Baseline and 24 Months
measure: Difference in number of Adverse Events between the study groups.
timeFrame: 3 Months, 6 Months, 12 Months, 18 Months, 24 Months
measure: Difference in number of fractures between the two study groups.
timeFrame: 3 Months, 6 Months, 12 Months, 18 Months, 24 Months
measure: Difference in urine calcium in a spot urine sample between the two study groups.
timeFrame: Baseline, 12 Months, and 24 Months.
Other outcomes:
Locations:
city: Kristiansund
country: Norway
facility: Kristiansund Hospital
state: Møre Og Romsdal
city: Ålesund
country: Norway
facility: Hofseth Biocare ASA
state: Møre Og Romsdal
city: Oslo
country: Norway
facility: Lovisenberg Diakonale Sykehus
Study officials:
affiliation: Møre og Romsdal Hospital Trust (Helse Møre og Romsdal), Kristiansund Hospital
name: Øystein B Lian, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: