Osteopenia Osteopenia
Conditions
Interventions
Isoflavone-based herbal product for one year,Placebo for one year
Experimental Drug,Placebo Comparator Drug
Isoflavone-based herbal product,Placebo
Sponsors
Chiang Mai University
Winona International, Co., Ltd.
Eligibility
Sex/Gender
Female
Age
50 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Postmenopausal women aged 50 to 80 years 2. Postmenopause with a minimum of 12 months of amenorrhea 3. Serum follicle-stimulating hormone level more than 30 IU/L 4. Bone mineral density with T-scores between -1.0 and -2.5 standard deviations 5. Body mass index not exceeding 29.9 kg/m2 6. Generally good health 7. Ability to provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Presence of any severe co-morbidity(ies), or uncontrolled medical condition(s); 2. Presence of any uncontrolled medical condition(s), or medical illness(es); 3. Presence of any condition(s) affecting bone metabolism; 4. Recent history of skeleton fracture(s); 5. Use of any medication(s) that may significantly influence bone metabolism; 6. Treating with anti-osteoporotic agents (except for calcium or vitamin D); 7. Receipt of estrogen therapy or other forms of hormone replacement therapy; 8. Undergoing radiographic contrast or nuclear medicine studies; 9. Hypersensitivity or allergy to the investigational product; 10. Any medical condition(s) in which the ingredients of the investigational product are contraindicated; 11. Any condition(s) that impairs swallowing or ingestion of the investigational product; 12. History of alcoholism; 13. Current heavy smoking or recent substance use; 14. Use of any dietary supplement(s) or other products that affect bone metabolism; 15. Concurrent participation in another clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone mineral density 0 and 12 months DEXA,Bone turnover markers (e.g., beta-crosslaps, P1NP, osteocalcin) 0, 3, 6, 12 month ELISA and/or biochemistry lab | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life 0, 1, 3, 6, 9, 12 month Questionnaire,Safety lab (e.g., CBC, AST, ALT, Cr, Electrolytes) 0, 1, 3, 6, 9, 12 month Biochemistry central lab,Adverse events 1, 3, 6, 9, 12 month History taking and physical examination,Satisfaction 1, 3, 6, 9, 12 month Questionnaire,Body composition (exploratory) 0, 12 month DEXA or BIA,Equol status (exploratory) 0 or 1 month, and 12 month LC-MS/MS,Serum lipid profile (exploratory) 0, 3, 6 ,12 month Central lab,Serum vitamin D 0, 3, 6, 9, 12 month Biochemistry lab | — |
Countries
Thailand
Contacts
Public ContactNut Koonrungsesomboon
Faculty of Medicine, Chiang Mai University
Outcome results
None listed