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CompletedNCT00860964Updated Mar 17, 2009

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

A Phase 4 interventional study of Placebo and estradiol valerate in Osteoporosis, sponsored by Peking Union Medical College. Completed. Open to female participants aged 40 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-03-17.

Sponsored by Peking Union Medical College · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
221
Allocation
Randomized
Ages
40 Years to 60 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Osteoporosis

Keywords

  • estradiol valerate
  • Medroxyprogesterone
  • menopause
  • Lipid
  • Bone mineral density
  • Body Composition
03

In context

Osteoporosis

1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.

This study's enrollment of 221 is above the median of 95 across 1,133 interventional studies indexed under Osteoporosis.

Browse Osteoporosis studies →

Lead sponsor

Peking Union Medical College is the lead sponsor of 58 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
221 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Drug: Placebo

  • Experimental
    estradiol valerate

    Drug: estradiol valerate

Interventions

  • DrugPlacebo

    Placebo, calcium 900mg/d, VitD200iu/d and exercise

  • Drugestradiol valerate

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

06

What researchers measure

Primary outcomes

  1. Bone mineral density

    Time frame: 60 months

Secondary outcomes

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

    Time frame: 60 months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00860964
Lead sponsor
Peking Union Medical College
First posted
Mar 13, 2009
Start date
Feb 1998
Primary completion
Feb 2003
Completion
Dec 2006
Last update
Mar 17, 2009

Study contacts

Shou Q Lin, PhD
principal investigator · Gynecological endocrinology & women's health centre of Peking Union Medical College Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2009. You cannot join it, but the record below documents what was studied.

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