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 @ 4:30 AM
Ignite Modification Date:
2025-12-25 @ 4:30 AM
NCT ID:
NCT00489918
Eligibility Criteria:
Inclusion Criteria:
* Healthy postmenopausal women age 50 years or older
* At least three lumbar vertebrae (L1-L4) must be evaluable by dual energy x-ray absorptiometry (DXA) for bone mineral densitometry that is, without fracture or significant degenerative disease, as determined by the central imaging facility
* Have osteoporosis defined as: Either a T-score of ≤ -2.5 at the lumbar spine, femoral neck, or total hip, AND a T-score of at least \< -1.0 at the lumbar spine; or A T-score of ≤ -2.0 at the lumbar spine, femoral neck, or total hip, AND at least one vertebral fracture;
Exclusion Criteria:
* Active hepatitis;
* Active pancreatitis;
* Unstable cardiac disease;
* Unstable pulmonary disease;
* Celiac disease;
* Hyper- or hypo-parathyroidism;
* Hyperthyroidism;
* Cushing's disease;
* Osteomalacia;
* Paget's disease;
* Osteogenesis imperfecta;
* Known blood disorders;
* History of kidney stones;
* Impaired renal function;
* Autoimmune diseases;
* Bone metastases or a history of skeletal malignancies;
* Cancer history that includes any cancer within the previous 5 years, with the exception of squamous or basal cell carcinoma of the skin in which the lesions were fully resected with clear margins described in a written report by a pathologist, and the patient has had no recurrence of lesions for at least 1 year from the time of original resection;
* Any condition or disease that may interfere with the ability to have or the evaluation of a DXA scan, for example, severe osteoarthritis of the spine, spinal fusion, pedicle screws, history of vertebroplasty, or degenerative disease that results in insufficient number of evaluable lumbar vertebrae, or \>1 lumbar vertebral fracture in L1-L4;
* More than 4 vertebral fractures in T4-L4;
* Bilateral hip replacements;
* Use of fluoride (e.g. fluoride therapy for osteoporosis) or strontium at any time;
* Have received methotrexate or immunomodulatory agents with antiproliferative activity;
* With known dermatological disorders that would interfere with the study procedures or assessments, or with a history of contact dermatitis;
* With known allergy or sensitivity to tapes, adhesives, PTH, teriparatide or its analogs, or components of the Macroflux® systems;
* Who, in the opinion of the investigator, should not participate in the study, or may not be capable of following the study schedule for any reason; and
* Unwillingness or inability to abide by the requirements of the study.
* Have received any intravenous (IV) administered bisphosphonates in the past 24 months, or \>2 doses of IV administered bisphosphonates total;
* Use of oral bisphosphonates before randomization, including investigational bisphosphonates, unless: \<6 months of treatment and off for 6 months, or 6-12 months of treatment and off for 2 years, or \>12 months of treatment and off for 5 years;
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
50 Years
Study:
NCT00489918
Study Brief:
Protocol Section:
NCT00489918