Clinical trial NCT04040010: The Effects of Bovine Colostrum in Bone Metabolism in Humans
Official title: The Effects of Bovine Colostrum in Bone Metabolism in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteopenia
Osteoporosis
Keywords: bone metabolism
Postmenopausal women
bone markers
bovine colostrum
DXA
Lead sponsor: University of Thessaly
Sponsor class: OTHER
Collaborators: name: European Commission
First posted: 2019-07-31
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: PREVENTION

Brief summary: Osteoporosis constitutes a major public health concern. For instance, in European Union 1 in 3 women and at least 1 in 6 men will suffer an osteoporotic fracture during their lifespan. The burden of osteoporosis is estimated to raise 25% by 2025. Worldwide, by 2050, the incidence of osteoporotic fractures is expected to increase 240% in women and 310% in men compared to 1990. The aforementioned estimates might indicate the existence of some gaps related to current products on the market for prevention and treatment of osteoporosis. Actually, the use of the approved pharmacological agents for osteoporosis have been decreasing in European Union and worldwide. Patients are becoming increasingly reluctant to take medicines; even those with severe osteoporosis are refusing treatment. Recent published reports on the matter revealed that patients fear the side effects of current pharmacological agents. Actually, therapy with bisphosphonates, the most prescribed medication for the treatment of postmenopausal, glucocorticoid-induced and male osteoporosis has been associated with severe side effects as osteonecrosis of the jaw and atypical femoral fractures.

Colostrum, a milky substance produced by mammals, known to be responsible for the development of the immune and skeleton systems of the offspring, has on its constituent's lactoferrin (LF). This multi-functional protein has been shown to affect both bone resorbing and bone formation pathways. The safety and tolerance on the use of bovine colostrum in humans (children and adults) have been well documented; it has a 'Generally Recognized As Safe' status from the United States Food and Drug Administration. Allergies and lactose intolerance, which are main shortcomings of milk consumption, have not been reported in relation to colostrum. Actually, human colostrum and bovine colostrum share the same bioactive components, but bovine sources are more potent than that of human. In accordance, bovine colostrum supplementation has been used in several therapeutic applications as gastrointestinal disorders, allergies and autoimmune diseases, viral and bacterial illnesses, and HIV-associated immunomodulation HIV. However, the effectiveness of bovine colostrum (as a whole and not only LF) to reduce bone losses has not been considered yet. Therefore, this study aims at analyzing the effects of bovine colostrum in diminishing bone mass losses in humans.

Detailed description: Postmenopausal women (without any bone condition), osteopenia and osteoporosis patients (female and male) will be invited to join the study. Participants enrolling the project will be first measured on the following parameters: 1) general characteristics (age, sex, medical history); 2) bone mass parameters through Dual-energy X-ray absorptiometry (DXA); 3) bone formation and resorption markers (alkaline phosphatase, osteocalcin, N-telopeptides and urine deoxypyridinoline). After measuring the aforementioned parameters, consenting participants will be randomized into the following groups: Group 1: postmenopausal women taking colostrum supplementation; Group 2: postmenopausal women taking placebo; Group 3: osteopenia patients taking colostrum supplementation; Group 4: osteopenia patients taking placebo; Group 5: osteoporosis patients taking colostrum supplementation; Group 6: osteoporosis patients taking placebo. Power calculations (90% power, 0.05%) were performed in order to calculate the sample size needed in each group (considering stratification according to group, a minimum of 7 participants in each group are needed). Following 5 months intervention, participants will be re-assessed on the following parameters: 1) general characteristics (age, sex, medical history); 2) bone mass parameters through Dual-energy X-ray absorptiometry (DXA); 3) bone formation and resorption markers (alkaline phosphatase, osteocalcin, N-telopeptides and urine deoxypyridinoline).

Eligibility criteria: Inclusion Criteria:

* Postmenopausal women (no menses for the last year at least);
* Osteoporosis patients (female): T-score\<-2.5 at the femoral neck (or other anatomical site);
* Osteoporosis patients (male): T-score\<-2.5 at the femoral neck (or other anatomical site)
* Osteopenia patients (female): T-score\<-1.0 at the femoral neck (or other anatomical site);
* Osteopenia patients (male): T-score\<-1.0 at the femoral neck (or other anatomical site)
* Patients taking drugs/ supplements for osteoporosis will be accepted in the study after going through a wash-up period

Exclusion Criteria:

* Women with irregular menses (i.e. with no established menopause)
* Patients taking medications for other diseases known to interfere with bone metabolism
* Patients with other chronic diseases (e.g. diabetes)

Primary outcomes:
measure: Change of alkaline phosphatase (μg/L)
timeFrame: Change from baseline of alkaline phosphatase at five months
measure: Change of osteocalcin (μg/L)
timeFrame: Change from baseline of osteocalcin at five months
measure: Change of deoxypyridinoline (mmol/L)
timeFrame: Change from baseline of deoxypyridinoline at five months
measure: Change of C-terminal telopeptide (CTX) (pg/mL)
timeFrame: Change from baseline of C-terminal telopeptide at five months
measure: Change of bone mineral density (g/cm2)
timeFrame: Change from baseline of bone mineral density at five months
measure: Change of bone mineral content (gr)
timeFrame: Change from baseline of bone mineral content at five months
Secondary outcomes:
Other outcomes:
Locations:
city: Tríkala
country: Greece
facility: FAME Lab, Department of Exercise Science, University of Thessaly
state: Thessaly
Study officials:
References: