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 @ 3:38 AM
Ignite Modification Date:
2025-12-25 @ 3:38 AM
NCT ID:
NCT01551602
Eligibility Criteria:
Inclusion Criteria:
* Healthy postmenopausal ethnic Japanese women; At least 45 years of age at the time consent is obtained; and Give voluntary consent in writing with a sufficient understanding of the study.
Exclusion Criteria:
* Clinical abnormality identified in the laboratory tests
* Weight \< 40.0 kg
* Body mass index \< 17.5 or \>=30.5
* History of disease of the kidneys, liver, heart, brain, or other organ that makes them ineligible as subjects
* Previously received radiation treatment potentially affecting bone
* Systolic blood pressure \< 90 mmHg
* QTc exceeds 470 msec in a 12-lead electrocardiography
* Serum calcium level exceeding 10.4 mg/dL
* History of contact dermatitis or skin disease potentially compromising study evaluation
* Used drugs which impact bone metabolism in the 8-week period preceding investigational product administration
* Used a bisphosphonate;
* Used a teriparatide product;
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
45 Years
Study:
NCT01551602
Study Brief:
Protocol Section:
NCT01551602