A Multi-center study to determine effects of various doses of Macroflux PTH in women with
osteoporosis
Minimum age: 50 Years.
Maximum age: N/A.
Gender(s): Female.
Inclusion Criteria:
- Healthy postmenopausal women age 50 years or older
- At least three lumbar vertebrae (L1-L4) must be evaluable by DXA for BMD 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;