Dose Ranging Study - Macroflux PTH in Postmenopausal Women With Osteoporosis

This study has been completed.
Sponsor:
Information provided by:
Zosano Pharma Inc.
ClinicalTrials.gov Identifier:
NCT00489918
First received: June 19, 2007
Last updated: May 7, 2009
Last verified: May 2009
  Purpose

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


Condition Intervention Phase
Osteoporosis
Drug: teriparatide
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Dose Ranging Study of the Effects of Macroflux® PTH Compared With Macroflux® Placebo and FORTEO® in Postmenopausal Women With Osteoporosis

Resource links provided by NLM:


Further study details as provided by Zosano Pharma Inc.:

Primary Outcome Measures:
  • 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. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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®; [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • To compare the pharmacokinetics of 3 doses of Macroflux® PTH to FORTEO® [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • To evaluate the effect of three doses of Macroflux® PTH on total hip, femoral neck and forearm BMD relative to placebo and FORTEO® [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • 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 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 165
Study Start Date: June 2007
Study Completion Date: August 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Macroflux® placebo
Macroflux® placebo patch
Drug: teriparatide
Macroflux® patch applied to the abdomen for 30 minutes daily
Other Name: PTH(1-34)
Experimental: Macroflux® 20 mcg
Macroflux® 20 mcg patch
Drug: teriparatide
Macroflux® patch applied to the abdomen for 30 minutes daily
Other Name: PTH(1-34)
Experimental: Macroflux® 30 mcg
Macroflux® 30 mcg patch
Drug: teriparatide
Macroflux® patch applied to the abdomen for 30 minutes daily
Other Name: PTH(1-34)
Experimental: Macroflux® 40 mcg
Macroflux® 40 mcg patch
Drug: teriparatide
Macroflux® patch applied to the abdomen for 30 minutes daily
Other Name: PTH(1-34)
Active Comparator: FORTEO®
FORTEO® 20 mcg injection
Drug: teriparatide
FORTEO® injection administered subcutaneously (SC) either to the abdomen or thigh
Other Name: FORTEO®

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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;
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00489918

Sponsors and Collaborators
Zosano Pharma Inc.
Investigators
Study Director: Thorsten von Stein, MD, Ph.D Zosano Pharma Inc.
  More Information

No publications provided by Zosano Pharma Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mostafa Elhamy, Associate Director, Clinical Operations, Zosano Pharma
ClinicalTrials.gov Identifier: NCT00489918     History of Changes
Other Study ID Numbers: CP-2006-001
Study First Received: June 19, 2007
Last Updated: May 7, 2009
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Mexico: Ministry of Health

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Teriparatide
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014