Effects of Osteo-F on bone health
- Conditions
- Diseases of the musculoskeletal system and connective tissue
- Registration Number
- KCT0006718
- Lead Sponsor
- BOIN BIO Convergence
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 120
1) Menopausal women over 45 years of age
2) A woman who do not take menopause-related drugs or estrogen
3) A person who agrees to participate in the study voluntarily and sign the informed consents
1) A person who diagnosed with or undergoing treatment for osteoporosis
2) A person who suffering from diseases that affect bone metabolism (thyroid or parathyroid disease, Cushing's syndrome, diabetes, kidney disease, ovarian cancer, etc.)
3) A person who has received hormone replacement therapy (steroids, female hormones, thyroid hormones) within the last 3 months
4) A person who has continuously taken osteoporosis-related Western medicines, herbal medicines, or bone health-related health functional foods (calcium, vitamin D preparations, etc.) within the last 3 months
5) Patients with uncontrolled high blood pressure despite taking medication
6) Underweight or Obesity (BMI < 18.5 kg/m2 or BMI = 30.0 kg/m2)
7) A person who has a history of vertebral compression fractures or who have had spinal surgery
8) Rheumatoid disease, asthma, AIDS patients
9) Respiratory disease (chronic obstructive pulmonary disease), heart disease, chronic renal failure
10) A person who has gallbladder disease or gastrointestinal disease (gastrectomy, inflammatory bowel disease, malabsorption), gout, or porphyria
11) A persons with mental disorders such as schizophrenia, alcoholism, and drug addiction
12) Renal dysfunction (creatinine rise more than 1.5 times the upper limit of normal), liver dysfunction (increase of more than 2.5 times the upper limit of normal for AST and ALT), malignancy, and other diseases that the investigator considers inappropriate for this study
13) A person with allergy or hypersensitivity to ingredients of investigational product.
14) A person who have been diagnosed with or treated for cancer within the past 5 years
15) A person who have had surgery within the last 6 months
16) A person who has participated in other clinical studies within 1 month prior to the screening visit
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Dual-energy X-ray absorptiometry(DXA)
- Secondary Outcome Measures
Name Time Method Bone health related indicators(Osteocalcin, Calcium, Phosphorus, ALP, Bone-specific alkaline Phosphatase(BSALP), C-terminal telopeptide of type 1collagen, Vitamin D, parathyroid hormone(PTH));Muscle function related indicators(hand grip,skeletal muscle index(SMI), Skeletal muscle mass, Appendicular skeletal muscle mass(ASM)/weight * 100);Muscle function related blood indicators( Creatinine, Creatine Kinase(CK), Lactate dehydrogenase(LDH))