OsteoporosisPhase 4NCT00860964
A Study of Prevention and Treatment of Postmenopausal Osteoporosis in Chinese Women
A Phase 4 study testing estradiol valerate in people with Osteoporosis, run by Peking Union Medical College.
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. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- estradiol valerate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 221 participants
- Where
- No sites listed yet
- Study dates
- Feb 1998to Dec 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
About this study
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.
- Conditions
- Osteoporosis
- Being tested
- Placebo, estradiol valerate
- Keywords
- estradiol valerate, Medroxyprogesterone, menopause, Lipid, Bone mineral density, Body Composition
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo, calcium 900mg/d, VitD200iu/d and exercise
estradiol valerateDrug
estradiol valerate 1mg/d,medroxyprogesterone 6mg/d for 10 days,calcium 900mg/d, VitD200iu/d and exercise
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| estradiol valerate | Experimental | Not described Receives: Drug: estradiol valerate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mineral density
Measured: 60 months
Secondary outcomes (1)
ALT, Cr, TG, TC, HDL-C, LDL-C, Body Composition, Breast Ultrasound, Pelvic ultrasound
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2009 (estimated)
- Study startFeb 1998
- Primary completionFeb 2003
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College
- Sponsor type
- University, hospital or other
- Investigators
- Shou Q Lin, PhD, Principal investigator, Gynecological endocrinology & women's health centre of Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00860964
- Sponsor's protocol ID
- CMB 97-667
- Status last verified
- Mar 2009
- First submitted
- 12 Mar 2009
- Last updated
- 17 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Prevention and Treatment of Postmenopausal Osteoporosis in Chinese Women
- ClinicalTrials.gov ID
- NCT00860964
- Acronym / sponsor ID
- CMB 97-667
- Conditions
- Osteoporosis
- Keywords
- estradiol valerate, Medroxyprogesterone, menopause, Lipid, Bone mineral density, Body Composition
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- Peking Union Medical CollegeUniversity, hospital or other
- Study start
- Feb 1998
- Primary completion
- Feb 2003 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 13 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| estradiol valerate | Experimental | Drug: estradiol valerate |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Patients with informed consent.
- Breast Cancer inform possible danger.
- Physical and mental health.
- Age between 40 ~ 55 years old.
- Women with Menopause syndrome or menstrual disorders.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo, calcium 900mg/d, VitD200iu/d and exercise | Drug | Placebo |
| estradiol valerateestradiol valerate 1mg/d,medroxyprogesterone 6mg/d for 10 days,calcium 900mg/d, VitD200iu/d and exercise | Drug | estradiol valerate |
Primary outcome
Bone mineral density
Time frame: 60 months
1 secondary outcome
ALT, Cr, TG, TC, HDL-C, LDL-C, Body Composition, Breast Ultrasound, Pelvic ultrasound
Time frame: 60 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shou Q Lin, PhD principal investigator
Gynecological endocrinology & women's health centre of Peking Union Medical College Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing estradiol valerate in people with Osteoporosis, run by Peking Union Medical College.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone mineral density (time frame: 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2009.