Clinical trial NCT05381168: Calcium From Fish Bone in Volunteers With Osteopenia
Official title: Efficacy and Safety of Calcium From Fish Bone in Volunteers With Osteopenia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteopenia
Keywords: osteopenia
calcium
fish bone
efficacy
safety
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2022-05-19
Enrollment: 48
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The volunteers are divided into 2 groups which are calcium from fish bone treatment group and calcium carbonate treatment group. Both groups receive the calciums every day for 6 months.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Bone mineral density score
timeFrame: 6 months
Secondary outcomes:
measure: Osteocalcin level
timeFrame: 6 months
measure: Total procollagen type-1 N-terminal propeptide (P1NP) level
timeFrame: 6 months
measure: Beta-crosslaps level
timeFrame: 6 months
measure: Parathyroid hormone (PTH) level
timeFrame: 6 months
measure: Blood calcium level
timeFrame: 6 months
measure: Blood phosphate level
timeFrame: 6 months
measure: Vitamin D level
timeFrame: 6 months
measure: Liver function level
timeFrame: 6 months
measure: Creatinine level
timeFrame: 6 months
measure: Blood urea nitrogen level
timeFrame: 6 months
measure: Pain score
timeFrame: 6 months
measure: Short physical performance battery score
timeFrame: 6 months
measure: Grip strength
timeFrame: 6 months
measure: Skin allergic reactions
timeFrame: 6 months
measure: Respiratory tract abnormality
timeFrame: 6 months
measure: Gastrointestinal tract abnormality
timeFrame: 6 months
measure: Satisfaction level
timeFrame: 6 months
Other outcomes:
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