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

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00860964
• Other study ID #: CMB 97-667
• Status: Completed
• Phase: Phase 4
• First received: March 12, 2009
• Last updated: March 16, 2009
• Start date: February 1998
• Est. completion date: December 2006

Study information

• Verified date: March 2009
• Source: Peking Union Medical College
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 221
• Est. completion date: December 2006
• Est. primary completion date: February 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal

Intervention

Drug:
• Placebo
Placebo, calcium 900mg/d, VitD200iu/d and exercise
• estradiol valerate
estradiol valerate 1mg/d,medroxyprogesterone 6mg/d for 10 days,calcium 900mg/d, VitD200iu/d and exercise

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone mineral density		60 months	No
Secondary	ALT, Cr, TG, TC, HDL-C, LDL-C, Body Composition, Breast Ultrasound, Pelvic ultrasound		60 months	Yes