Efficacy and Safety of Calcium From Fish Bone in Volunteers With Osteopenia
试验速览
- 阶段
- 不适用
- 入组人数
- 48
- 主要终点
- Bone mineral density score
研究概览
简要总结
The aims of this study are to explore efficacy and safety of calcium from fish bone in volunteers with osteopenia. The volunteers are divided into 2 groups which are calcium from fish bone treatment group and calcium carbonate treatment group. Both groups received the calciums everyday for 6 months. Bone mineral density, blood examination, physical examination, adverse events, and satisfaction are evaluated before and after treatment.
详细描述
The aims of this study are to explore efficacy and safety of calcium from fish bone in volunteers with osteopenia. The volunteers are divided into 2 groups which are calcium from fish bone treatment group and calcium carbonate treatment group. Both groups received the calciums everyday for 6 months. Bone mineral density is analyzed before and after treatment. Osteocalcin, total procollagen type-1 N-terminal propeptide (P1NP), beta-crosslaps, parathyroid hormone (PTH), calcium, phosphate level, vitamin D level (Serum 25(OH)D), albumin, aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase (ALP), creatinine (Cr), blood urea nitrogen (BUN), and complete blood count (CBC) are assessed before and after taking for 3 and 6 months. Physical performance and food diary are also tested and records. Moreover, adverse effects including skin allergy, gastrointestinal abnormality, respiratory abnormality are evaluated. Satisfaction is asked after treatment.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male age more than 70 years or female age more than 65 years or all age volunteers that have at least 1 risk factors which are menopause before 45 years, menopause with the height reduction (more than 4 cm), body mass index less than 20 kg/mm2, bone fracture history, taking some medicine that has an effect on bone density reduction, have disease that has an effect on bone density reduction, Father and mother have bone fracture history, fracture risk assessment tool (FRAX) in intermediate risk, osteoporosis self-assessment tool for asian (OSTA) score, khon kaen osteoporosis study (KKOS) score in intermediate risk or higher intermediate risk
- •Bone mineral density between -1 to -2.5
- •No osteosclerosis
- •Can read and write
- •Willing to be volunteer
排除标准
- •Allergic to calcium, magnesium, phosphorus, zinc, collagen, and osteocalcin
- •Taking calcium or vitamin D with in 14 days before the study start
- •Taking osteosclerosis' medicine
- •Have uncontrolled diseases
- •Pregnancy and lactation
- •Participating in other study
结局指标
主要结局
Bone mineral density score
时间窗: 6 months
Bone mineral density score is measured using dual energy x-ray absorptiometry scanner (DEXA scanner). It shows in term of T-score. The outcomes are compared bone mineral density score of calcium from fish bone group to calcium carbonate group.
次要结局
- Blood urea nitrogen level(6 months)
- Vitamin D level(6 months)
- Blood calcium level(6 months)
- Parathyroid hormone (PTH) level(6 months)
- Short physical performance battery score(6 months)
- Grip strength(6 months)
- Satisfaction level(6 months)
- Osteocalcin level(6 months)
- Blood phosphate level(6 months)
- Pain score(6 months)
- Gastrointestinal tract abnormality(6 months)
- Total procollagen type-1 N-terminal propeptide (P1NP) level(6 months)
- Beta-crosslaps level(6 months)
- Liver function level(6 months)
- Creatinine level(6 months)
- Skin allergic reactions(6 months)
- Respiratory tract abnormality(6 months)
研究者
Pornanong Aramwit, Pharm.D., Ph.D
Professor
Chulalongkorn University