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

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zosano Pharma Corporation; Zosano Pharma Inc.
• Treatments: Teriparatide

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;