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:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2025-12-25 @ 2:36 AM
NCT ID:
NCT00960934
Eligibility Criteria:
Inclusion Criteria:
* Postmenopausal for at least 5 years
* No history of fragility fracture, unless participant is not willing to take marketed osteoporosis therapy or is not a candidate for marketed osteoporosis therapy
* Agrees not to use medications for osteoporosis except medications associated with the study
* Areal bone mineral density (BMD) T-score \<-2.5 at one or more of the following 4 BMD sites: total hip, femoral neck, trochanter, or lumbar spine and is ≥ -3.5 at all 4 BMD sites. Participants unwilling to take or ineligible for marketed osteoporosis therapy may have one or more areal BMD T-scores of \< -3.5
Exclusion Criteria:
* Unable to undergo dual-energy X-ray absorptiometry (DXA) scan due to obesity (ie, weight \>250 lbs)
* Use of oral bisphosphonates in the 6 months prior to study screening, for more than 3 months in the past 2 years, or lifetime use of more than 6 months
* Use of intravenous bisphosphonates, strontium, or growth hormone at any time
* Use of phenytoin or heparin within 2 weeks prior to Visit 1; use of raloxifene within 6 months prior to Visit 1
* Use of pioglitazone or rosiglitazone at study screening
* Use of estrogen ± progestin, in any form other than vaginal or topical application, for 6 months prior to Study Visit 1
* Prior total thyroidectomy
* Human immunodeficiency virus (HIV)- positive or acquired immune deficiency syndrome (AIDS)-related illness
* History of malignant cancer within 5 years of study screening, except for certain skin or cervical cancers
* History of Paget's disease and/or kidney stones
* An active user of any illicit drug
* History of or active alcohol abuse
* Participated in an investigational drug study within the past 30 days
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
45 Years
Maximum Age:
85 Years
Study:
NCT00960934
Study Brief:
Protocol Section:
NCT00960934