NCT00860964

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
221

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 1998

Longer than P75 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 1998

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2003

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

March 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 13, 2009

Completed
Last Updated

March 17, 2009

Status Verified

March 1, 2009

Enrollment Period

5 years

First QC Date

March 12, 2009

Last Update Submit

March 16, 2009

Conditions

Osteoporosis

Keywords

estradiol valerateMedroxyprogesteronemenopauseLipidBone mineral densityBody Composition

Outcome Measures

Primary Outcomes (1)

  • Bone mineral density

    60 months

Secondary Outcomes (1)

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

    60 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

estradiol valerate

EXPERIMENTAL
Drug: estradiol valerate

Interventions

PlaceboDRUG

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

Placebo
estradiol valerateDRUG

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

estradiol valerate

Eligibility Criteria

Age40 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoporosis

Interventions

Estradiol

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

EstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Shou Q Lin, PhD

    Gynecological endocrinology & women's health centre of Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 12, 2009

First Posted

March 13, 2009

Study Start

February 1, 1998

Primary Completion

February 1, 2003

Study Completion

December 1, 2006

Last Updated

March 17, 2009

Record last verified: 2009-03