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

Primary Purpose

Osteoporosis

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Placebo
estradiol valerate
Sponsored by
Peking Union Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoporosis focused on measuring estradiol valerate, Medroxyprogesterone, menopause, Lipid, Bone mineral density, Body Composition

Eligibility Criteria

40 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    Placebo

    estradiol valerate

    Arm Description

    Outcomes

    Primary Outcome Measures

    Bone mineral density

    Secondary Outcome Measures

    ALT, Cr, TG, TC, HDL-C, LDL-C, Body Composition, Breast Ultrasound, Pelvic ultrasound

    Full Information

    First Posted
    March 12, 2009
    Last Updated
    March 16, 2009
    Sponsor
    Peking Union Medical College
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00860964
    Brief Title
    A Study of Prevention and Treatment of Postmenopausal Osteoporosis in Chinese Women
    Official Title
    A Study of Prevention and Treatment of Postmenopausal Osteoporosis in Chinese Women
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    February 1998 (undefined)
    Primary Completion Date
    February 2003 (Actual)
    Study Completion Date
    December 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Peking Union Medical College

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoporosis
    Keywords
    estradiol valerate, Medroxyprogesterone, menopause, Lipid, Bone mineral density, Body Composition

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    221 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Title
    estradiol valerate
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo, calcium 900mg/d, VitD200iu/d and exercise
    Intervention Type
    Drug
    Intervention Name(s)
    estradiol valerate
    Intervention Description
    estradiol valerate 1mg/d,medroxyprogesterone 6mg/d for 10 days,calcium 900mg/d, VitD200iu/d and exercise
    Primary Outcome Measure Information:
    Title
    Bone mineral density
    Time Frame
    60 months
    Secondary Outcome Measure Information:
    Title
    ALT, Cr, TG, TC, HDL-C, LDL-C, Body Composition, Breast Ultrasound, Pelvic ultrasound
    Time Frame
    60 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: All patients meet the criteria: Patients with informed consent. Breast Cancer inform possible danger. Physical and mental health. Menopausal transition meet the criteria: Age between 40 ~ 55 years old. Women with Menopause syndrome or menstrual disorders. The second to fourth lumbar spine bone mineral density to normal. Early postmenopause meet the criteria: Age between 45 ~ 60 years old. Spontaneous amenorrhea for more than six months and less than 5 years. The second to fourth lumbar spine bone mineral density was between -1 and -2.5 Standard deviation Compared with normal young women. Exclusion Criteria: Tobacco or alcohol abuser. History of various malignant diseases. Women with Serious chronic diseases, such as liver and kidney dysfunction. Women Suffering from endocrine diseases, such as Thyroid disease, Parathyroid disease,Adrenal disease and Osteomalacia. Women with Long-term application of drugs, such as Antiepileptic drug, Adrenocorticotropic hormone, Diuretics and Heparin. Women had used estrogen or calcitonin in the past 6 months. Women has added higher than the physiological requirements VitD. Who had taken bisphosphonates or sodium fluoride in the past 1 year. Women had been taking Chinese medicines or other unregistered food in past 3 months. 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 Secondary osteoporosis. 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. Doctor consider inappropriate to participate in because of other diseases.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Shou Q Lin, PhD
    Organizational Affiliation
    Gynecological endocrinology & women's health centre of Peking Union Medical College Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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

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