Clinical Drug Experience Knowledgebase

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;