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临床试验/NCT04040010
NCT04040010已完成不适用

The Effects of Bovine Colostrum in Bone Metabolism in Humans

Petros Dinas2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Change of bone mineral content (gr)

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Care Provider)

入排标准

性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

结局指标

主要结局

Change of bone mineral content (gr)

时间窗: Change from baseline of bone mineral content at five months

The bone mineral content (gr) will be analyzed via Dual-energy X-ray absorptiometry scan

Change of deoxypyridinoline (mmol/L)

时间窗: Change from baseline of deoxypyridinoline at five months

The deoxypyridinoline (mmol/L) will be analyzed via human serum samples using an appropriate ELISA kit

Change of C-terminal telopeptide (CTX) (pg/mL)

时间窗: Change from baseline of C-terminal telopeptide at five months

The C-terminal telopeptide (CTX) (pg/mL) will be analyzed via human serum samples using an appropriate ELISA kit

Change of alkaline phosphatase (μg/L)

时间窗: Change from baseline of alkaline phosphatase at five months

The alkaline phosphatase (μg/L) will be analyzed via human serum samples using an appropriate ELISA kit

Change of osteocalcin (μg/L)

时间窗: Change from baseline of osteocalcin at five months

The osteocalcin (μg/L) will be analyzed via human serum samples using an appropriate ELISA kit

Change of bone mineral density (g/cm2)

时间窗: Change from baseline of bone mineral density at five months

The bone mineral density (g/cm2) will be analyzed via Dual-energy X-ray absorptiometry scan

次要结局

未报告次要终点

研究者

发起方
Petros Dinas
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Petros Dinas

Senior Researcher in human physiology

University of Thessaly

研究点 (2)

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