Overview

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;