The Effects of Bovine Colostrum in Bone Metabolism in Humans

Petros Dinas

Status: Completed

Conditions: Osteoporosis; Osteopenia

Treatments: Dietary Supplement: Colostrum supplementation for bone loss

Study type: Interventional

Funder types: Other

Identifiers

NCT04040010

3. Colostrum & bone

Details and patient eligibility

About

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.

Full 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).

Enrollment: 60 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 6 patient groups, including a placebo group

Postmenopausal women colostrum supplement

Experimental group

Treatment:

Dietary Supplement: Colostrum supplementation for bone loss

Osteoporosis patients colostrum supplement

Experimental group

Treatment:

Dietary Supplement: Colostrum supplementation for bone loss

Osteopenia patients colostrum supplement

Experimental group

Treatment:

Dietary Supplement: Colostrum supplementation for bone loss

Postmenopausal women placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Colostrum supplementation for bone loss

Osteoporosis patients placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Colostrum supplementation for bone loss

Osteopenia patients placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Colostrum supplementation for bone loss