Dose Ranging Study - Macroflux Parathyroid Hormone (PTH) in Postmenopausal Women With Osteoporosis
Condition: Osteoporosis
MeSH terms: Osteoporosis
Intervention: teriparatide; teriparatide
Intervention description: Macroflux® patch applied to the abdomen for 30 minutes daily; FORTEO® injection administered subcutaneously (SC) either to the abdomen or thigh
Intervention MeSH terms: Teriparatide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 165.0
Sex: Female
Minimum age: 50 Years
Healthy volunteers: No

Summary:

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

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;