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Efficacy & Safety of ViaDerm-hPTH(1-34) Compared to Forteo SC in Postmenopausal Women With Osteoporosis

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by:
TransPharma Medical
ClinicalTrials.gov Identifier:
NCT00535860
First received: September 25, 2007
Last updated: July 9, 2009
Last verified: July 2009

September 25, 2007
July 9, 2009
April 2008
March 2009   (final data collection date for primary outcome measure)
Change from baseline to endpoint 96 days in procollagen 1 N-terminal propeptide (P1NP) [ Time Frame: Baseline, 96 days ] [ Designated as safety issue: No ]
The change in anabolic marker from baseline to end of the study. [ Time Frame: 3 months ]
Complete list of historical versions of study NCT00535860 on ClinicalTrials.gov Archive Site
  • Change from baseline in C-terminal telopeptide of type I collagen (CTX-1.) [ Time Frame: Baseline, 96 days ] [ Designated as safety issue: No ]
  • hPTH (1-34) Pharmacokinetic AUC of ViaDerm-hPTH (1-34) and teriparatide SC. [ Time Frame: Baseline, 96 days ] [ Designated as safety issue: No ]
  • Ratio of hPTH (1-34) AUC of transdermal treatment and subcutaneous injection [ Time Frame: Baseline, 96 days ] [ Designated as safety issue: No ]
  • Ratio of hPTH (1-34) Cmax of transdermal treatment and subcutaneous injection [ Time Frame: Baseline, 96 days ] [ Designated as safety issue: No ]
  • hPTH (1-34) Pharmacokinetic Cmax of ViaDerm-hPTH (1-34) and teriparatide SC. [ Time Frame: Baseline, 96 Days ] [ Designated as safety issue: No ]
  • Percentage of patients with serum total calcium above the upper limit of normal range [ Time Frame: Over 96 days ] [ Designated as safety issue: Yes ]
  • Percentage of patients with serum total calcium more than 1 mg/dl above the upper limit of normal range [ Time Frame: Over 96 days ] [ Designated as safety issue: Yes ]
  • Number of participants with hPTH (1-34) specific antibody immune response [ Time Frame: Baseline, 96 days ] [ Designated as safety issue: Yes ]
  • Draize score for erythema and edema [ Time Frame: Over 96 Days ] [ Designated as safety issue: Yes ]
  • Visual Analog Scale (VAS) pain assessment [ Time Frame: Over 96 days ] [ Designated as safety issue: Yes ]
•The change in resorption biomarker from baseline to end of study. •hPTH (1-34) Pharmacokinetic parameters of ViaDerm-hPTH (1-34) and Forteo SC at baseline and end of treatment. [ Time Frame: 3 months ]
Not Provided
Not Provided
 
Efficacy & Safety of ViaDerm-hPTH(1-34) Compared to Forteo SC in Postmenopausal Women With Osteoporosis
A Multicenter, Randomized, Parallel Study to Assess the Clinical Efficacy, Safety, and Tolerability of ViaDerm-hPTH (1-34) in Comparison to Subcutaneous Injection of Forteo in Postmenopausal Women With Osteoporosis

The purpose of this study is to assess the clinical efficacy, safety, and tolerability of ViaDerm-shPTH [1-34] transdermal delivery in comparison to subcutaneous injection of rhPTH[1-34] following 3-month treatment in postmenopausal women with Osteoporosis

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Osteoporosis
Drug: Teriparatide
Daily for 96 days
Other Names:
  • Forteo
  • Forsteo
  • LY333334
  • Experimental: 50 mcg
    ViaDerm transdermal delivery
    Intervention: Drug: Teriparatide
  • Experimental: 80 mcg
    Add Via-Derm transdermal delivery
    Intervention: Drug: Teriparatide
  • Active Comparator: 20 mcg
    Subcutaneous injection
    Intervention: Drug: Teriparatide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
104
March 2009
March 2009   (final data collection date for primary outcome measure)

Main Inclusive Criteria:

  • Post-menopausal women aged between 55 to 85 years (inclusive)
  • Posterior-Anterior lumbar vertebral and/or femoral neck BMD T-score by DXA ≤-2.5 SD.
  • Have normal serum PTH, thyroid stimulating hormone (TSH) (only for patients treated with thyroid hormone), and prolactin values.

Main Exclusive Criteria:

  • Subjects who have a clinical significant or unstable medical or surgical condition that may preclude safe and complete study participation
  • Current diagnoses of disorders known to affect bone metabolism including hyperthyroidism, hyperparathyroidism, osteomalacia, or Paget's disease
  • Prior osteoporosis treatment with fluoride or strontium at any time; or any IV treatment with bisphosphonates in the past or oral bisphosphonate for more than 1 month in the past 24 months prior to randomization.
  • Any condition or disease that may interfere with the ability to have, or to evaluate a DXA scan
Female
55 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   Hungary,   Israel
 
NCT00535860
CS 82-000-04, I2Y-MC-GHFE
No
Efrat Kochba, TransPharma Medical Ltd.
TransPharma Medical
Eli Lilly and Company
Study Director: Efrat Kochba, MD TransPharma-Medical Ltd.
TransPharma Medical
July 2009

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