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

June 19, 2007
May 7, 2009
June 2007
April 2008   (final data collection date for primary outcome measure)
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 ]
Not Provided
Complete list of historical versions of study NCT00489918 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Dose Ranging Study - Macroflux PTH in Postmenopausal Women With Osteoporosis
A Dose Ranging Study of the Effects of Macroflux® PTH Compared With Macroflux® Placebo and FORTEO® in Postmenopausal Women With Osteoporosis

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Osteoporosis
  • Drug: teriparatide
    Macroflux® patch applied to the abdomen for 30 minutes daily
    Other Name: PTH(1-34)
  • Drug: teriparatide
    FORTEO® injection administered subcutaneously (SC) either to the abdomen or thigh
    Other Name: FORTEO®
  • Placebo Comparator: Macroflux® placebo
    Macroflux® placebo patch
    Intervention: Drug: teriparatide
  • Experimental: Macroflux® 20 mcg
    Macroflux® 20 mcg patch
    Intervention: Drug: teriparatide
  • Experimental: Macroflux® 30 mcg
    Macroflux® 30 mcg patch
    Intervention: Drug: teriparatide
  • Experimental: Macroflux® 40 mcg
    Macroflux® 40 mcg patch
    Intervention: Drug: teriparatide
  • Active Comparator: FORTEO®
    FORTEO® 20 mcg injection
    Intervention: Drug: teriparatide
Cosman F, Lane NE, Bolognese MA, Zanchetta JR, Garcia-Hernandez PA, Sees K, Matriano JA, Gaumer K, Daddona PE. Effect of transdermal teriparatide administration on bone mineral density in postmenopausal women. J Clin Endocrinol Metab. 2010 Jan;95(1):151-8. Epub 2009 Oct 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
165
August 2008
April 2008   (final data collection date for primary outcome measure)

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;
Female
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00489918
CP-2006-001
No
Mostafa Elhamy, Associate Director, Clinical Operations, Zosano Pharma
Zosano Pharma Inc.
Not Provided
Study Director: Thorsten von Stein, MD, Ph.D Zosano Pharma Inc.
Zosano Pharma Inc.
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP