None listed
Conditions
Interventions
Dietary Supplement : Subjects will be randomized to receive LAEC or placebo. Subjects will orally self-adminster LAEC or placebo 4 tablets per day for 40weeks.
Sponsors
Dongwoodang
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) female subjects at least more than 45years of age inclusive with menopause a. have no orrhea for 12months b. have last orrhea since 6months ago and FSH > 40mlU/mL c. have both ovariectomy since 6weeks d. have hysterectomy and FSH > 40mlU/mL 2) have Osteopenia by DXA(Dual energy X-ray absorptiometry) 3) BMI of 18.5-35.0kg/m2 4) Subjects who agree the particpation in the trial and submit informed and consent before the beginning of the trial.
Exclusion criteria
Exclusion criteria: 1)The Patients with severe vitamin D which have more than 200IU per day or Calcium before 2weeks from visit2 2)The Patients with severe Bisphosphonate 3)AST(aspartate transaminase), ALT(alanine transaminase) = 2 times the upper limit of normal. 4)eGFR(Estimated glomerular filtration rate) value =60 mL/min/1.73 m2 5)The Patients who had atraumatic fracture or have lumbarcompression fracture 6)Subjects which in the opinion investigator could affect preclude evluation of response
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DXA(lumbar, femur neck, total hip) | — |
Secondary
| Measure | Time frame |
|---|---|
| bone metabolism index(BALP, Osteocalcin, Calcium, urine-NTX, urine Ca/Creatinine ratio, 25(OH)D) | — |
Countries
Korea, Republic of
Contacts
Public ContactNam Seok Joo
Ajou University
Outcome results
None listed