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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014