Dose Ranging Study - Macroflux Parathyroid Hormone (PTH) in Postmenopausal Women With Osteoporosis

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;