Dose Ranging Study - Macroflux PTH in Postmenopausal Women With Osteoporosis

Condition(s) targeted: Osteoporosis

Intervention: teriparatide (Drug); teriparatide (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Zosano Pharma Inc.

Official(s) and/or principal investigator(s):
Thorsten von Stein, MD, Ph.D, Study Director, Affiliation: Zosano Pharma Inc.

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

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: To determine the effect of 3 doses of Macroflux® human parathyroid hormone (1-34) (PTH) administered for 24 weeks on lumbar spine bone mineral density (BMD) compared to Macroflux® placebo.

Secondary outcome:

To determine the systemic and topical safety of 3 doses of Macroflux® PTH, self administered daily for 24 weeks in postmenopausal women with osteoporosis compared to Macroflux® placebo and FORTEO®;

To compare the pharmacokinetics of 3 doses of Macroflux® PTH to FORTEO®

To evaluate the effect of three doses of Macroflux® PTH on total hip, femoral neck and forearm BMD relative to placebo and FORTEO®

To determine the effect of 3 doses of Macroflux® PTH administered on serum procollagen 1 N-terminal propeptide (P1NP) and serum C-terminal cross-linking telopeptide of type 1 collagen (CTX)compared to Macroflux® placebo

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

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;

Starting date: June 2007
Last updated: May 7, 2009