Efficacy and safety of Lycium Chinese extract complex on women with osteopenia; A 40week, Randomized, Double-blind, Placebo-Controlled Clinical Trial

Not Applicable

Recruiting

• Conditions: Diseases of the musculo-skeletal system and connective tissue

• Registration Number: KCT0002576
• Lead Sponsor: Dongwoodang

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 100

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

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

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
DXA(lumbar, femur neck, total hip)

Secondary Outcome Measures

Name	Time	Method
bone metabolism index(BALP, Osteocalcin, Calcium, urine-NTX, urine Ca/Creatinine ratio, 25(OH)D)