NCT00860964

A Study of Prevention and Treatment of Postmenopausal Osteoporosis in Chinese Women

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 221 (actual)
• Sponsor: Peking Union Medical College · Academic / Other
• Sex: Female
• Age: 40 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The purpose of this trial is to study the efficacy and safety of low dose of estradiol valerate in the prevention and treatment of postmenopausal osteoporosis.

Detailed description

Research purposes: To assess the Impact of hormone therapy on quality of life in early post-menopausal women; To assess the Impact of hormone therapy on cardiovascular system in early post-menopausal women; To assess the Impact of hormone therapy on cognitive function in early post-menopausal women; To assess the Impact of hormone therapy on osteoporosis in early post-menopausal women. Study Design: The clinical trial research was divided into 2 groups. Treatment group given estradiol valerate 1mg/d, periodic application of medroxyprogesterone 6mg/d for 10 days, calcium 900mg/d, VitD200iu/d and exercise(Brisk walking every day 2 times, continued for 10 minutes each time). Control group given placebo, calcium,VitD and exercise were same with treatment group.

Conditions

• Osteoporosis

Interventions

Type	Name	Description
DRUG	Placebo	Placebo, calcium 900mg/d, VitD200iu/d and exercise
DRUG	estradiol valerate	estradiol valerate 1mg/d,medroxyprogesterone 6mg/d for 10 days,calcium 900mg/d, VitD200iu/d and exercise

Timeline

• Start date: 1998-02-01
• Primary completion: 2003-02-01
• Completion: 2006-12-01
• First posted: 2009-03-13
• Last updated: 2009-03-17