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

A Dose Ranging Study of the Effects of Macroflux® PTH Compared With Macroflux® Placebo and FORTEO® in Postmenopausal Women With Osteoporosis

A Multi-center study to determine effects of various doses of Macroflux Parathryroid Hormone (PTH) in women with osteoporosis

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;