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

March 16, 2009 updated by: Peking Union Medical College
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

221

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo, calcium 900mg/d, VitD200iu/d and exercise
Experimental: estradiol valerate
Drug: estradiol valerate
estradiol valerate 1mg/d,medroxyprogesterone 6mg/d for 10 days,calcium 900mg/d, VitD200iu/d and exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bone mineral density
Time Frame: 60 months
60 months

Secondary Outcome Measures

Outcome Measure
Time Frame
ALT, Cr, TG, TC, HDL-C, LDL-C, Body Composition, Breast Ultrasound, Pelvic ultrasound
Time Frame: 60 months
60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College

Investigators

  • Principal Investigator: Shou Q Lin, PhD, Gynecological endocrinology & women's health centre of Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 1998

Primary Completion (Actual)

February 1, 2003

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

March 12, 2009

First Submitted That Met QC Criteria

March 12, 2009

First Posted (Estimate)

March 13, 2009

Study Record Updates

Last Update Posted (Estimate)

March 17, 2009

Last Update Submitted That Met QC Criteria

March 16, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMB 97-667

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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