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

Phase 4

Completed

• Conditions: Osteoporosis
• Interventions: Drug: Placebo; Drug: estradiol valerate

• Registration Number: NCT00860964
• Lead Sponsor: Peking Union Medical College

Brief 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.

Study Timeline

• Study Start: 1998-02
• Primary Completion: 2003-02
• Study Completion: 2006-12
• Status Verified: 2009-03
• Study First Submitted: 2009-03-12
• Study First Submitted QC: 2009-03-12
• Study First Posted: 2009-03-13
• Last Update Submitted: 2009-03-16
• Last Update Posted: 2009-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 221

Inclusion Criteria

All patients meet the criteria:

1. Patients with informed consent.
2. Breast Cancer inform possible danger.
3. Physical and mental health.

Menopausal transition meet the criteria:

1. Age between 40 ~ 55 years old.
2. Women with Menopause syndrome or menstrual disorders.
3. The second to fourth lumbar spine bone mineral density to normal.

Early postmenopause meet the criteria:

1. Age between 45 ~ 60 years old.
2. Spontaneous amenorrhea for more than six months and less than 5 years.
3. The second to fourth lumbar spine bone mineral density was between -1 and -2.5 Standard deviation Compared with normal young women.

Exclusion Criteria

1. Tobacco or alcohol abuser.
2. History of various malignant diseases.
3. Women with Serious chronic diseases, such as liver and kidney dysfunction.
4. Women Suffering from endocrine diseases, such as Thyroid disease, Parathyroid disease,Adrenal disease and Osteomalacia.
5. Women with Long-term application of drugs, such as Antiepileptic drug, Adrenocorticotropic hormone, Diuretics and Heparin.
6. Women had used estrogen or calcitonin in the past 6 months.
7. Women has added higher than the physiological requirements VitD.
8. Who had taken bisphosphonates or sodium fluoride in the past 1 year.
9. Women had been taking Chinese medicines or other unregistered food in past 3 months.
10. Women with one of the following medical history or disease: Thrombophlebitis, estrogen-related thrombosis or thromboembolism, Cerebrovascular accident, with known or suspected estrogen-dependent tumor, undiagnosed vaginal bleeding, Cervical Pap smear graded at 3 or more, Serious uterine disorders, Serious breast disorders, Serious gallbladder disease, Severe hypertension and Hypercholesterolemia
11. Secondary osteoporosis.
12. Participants' lumbar spine anatomy(at least L1~L4) is not suitable to do dual-energy X-ray absorptiometry measured, such as obvious scoliosis, bone injury and Orthopedic surgery Sequelae.
13. Doctor consider inappropriate to participate in because of other diseases.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
estradiol valerate	estradiol valerate	-

Primary Outcome Measures

Name	Time	Method
Bone mineral density	60 months

Secondary Outcome Measures

Name	Time	Method
ALT, Cr, TG, TC, HDL-C, LDL-C, Body Composition, Breast Ultrasound, Pelvic ultrasound	60 months