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 @ 6:47 PM
Ignite Modification Date:
2025-12-24 @ 6:47 PM
NCT ID:
NCT01604057
Eligibility Criteria:
Inclusion Criteria:
* Postmenopausal Females Age ≥ 45 years.
* Weight \> 45 kg and \< 90 kg
* Normal nasal examination at baseline.
* Low bone mass at lumbar spine, total hip or femoral neck (BMD T-score of ≤ - 1.5 or lower) or a recent (within 5 years of baseline) history of fragility fracture (excluding fractures of hands, feet, face and/or skull) and a T-score of -1.0 or lower at lumbar spine, total hip or femoral neck
Exclusion Criteria:
* Serious Medical Condition
* History of diseases which affect bone metabolism other than postmenopausal osteoporosis such as Paget's disease, any secondary causes of osteoporosis, hypoparathyroidism, or hyperparathyroidism
* Have a history of cancer within the past 5 years, except for basal cell carcinoma
* Have hypocalcemia or hypercalcemia from any cause or have a recent history of kidney stones or pre-existing hypercalciuria;
* Have used any of the mostly commonly prescribed osteoporosis medications within 3 months of starting the investigational product, or for more than 1 month at any time within 6 months prior to starting investigational product
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
45 Years
Study:
NCT01604057
Study Brief:
Protocol Section:
NCT01604057