Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2025-12-24 @ 10:54 PM
NCT ID:
NCT00626769
Eligibility Criteria:
Inclusion Criteria:
* Good general health
* Have not had a menstrual period in the preceding year
* Had not undergone surgically induced menopause
* Had a follicle-stimulating hormone level \> 50 IU/liter and a serum 17 beta-estradiol level ≤ 100 pmol/liter
* Established osteopenia (-1\<T-score\<-2.5 SD)
Exclusion Criteria:
* Clinical or laboratory evidence of confounding systemic diseases, such as cardiovascular, hepatic, or renal disorders
* Coagulopathy, use of oral or transdermal estrogen, progestin, androgen or other steroids
* Biphosphonates, cholesterol-lowering therapy or cardiovascular medications in the preceding six months
* Smoking habit of more than two cigarettes per day
* Previous treatment with any drug that could affect the skeleton in the preceding year
* A family history of estrogen-dependent cancer
* BMD at femoral neck \> 0.795 g/cm2; this BMD value corresponds to a T score of -1 standard deviation
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
49 Years
Maximum Age:
67 Years
Study:
NCT00626769
Study Brief:
Protocol Section:
NCT00626769