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

Sponsor
TransPharma Medical (Industry)
Overall Status
Completed
CT.gov ID
NCT00535860
Collaborator
Eli Lilly and Company (Industry)
104
Enrollment
10
Locations
3
Arms
11
Duration (Months)
10.4
Patients Per Site
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
104 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Apr 1, 2008
Actual Primary Completion Date :
Mar 1, 2009
Actual Study Completion Date :
Mar 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: 50 mcg

ViaDerm transdermal delivery

Drug: Teriparatide
Daily for 96 days
Other Names:
  • Forteo
  • Forsteo
  • LY333334

    		•
    Experimental: 80 mcg

    Add Via-Derm transdermal delivery

    Drug: Teriparatide
    Daily for 96 days
    Other Names:
  • Forteo
  • Forsteo
  • LY333334

    		•
    Active Comparator: 20 mcg

    Subcutaneous injection

    Drug: Teriparatide
    Daily for 96 days
    Other Names:
  • Forteo
  • Forsteo
  • LY333334

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change from baseline to endpoint 96 days in procollagen 1 N-terminal propeptide (P1NP) [Baseline, 96 days]

    Secondary Outcome Measures

    1. Change from baseline in C-terminal telopeptide of type I collagen (CTX-1.) [Baseline, 96 days]

    2. hPTH (1-34) Pharmacokinetic AUC of ViaDerm-hPTH (1-34) and teriparatide SC. [Baseline, 96 days]

    3. Ratio of hPTH (1-34) AUC of transdermal treatment and subcutaneous injection [Baseline, 96 days]

    4. Ratio of hPTH (1-34) Cmax of transdermal treatment and subcutaneous injection [Baseline, 96 days]

    5. hPTH (1-34) Pharmacokinetic Cmax of ViaDerm-hPTH (1-34) and teriparatide SC. [Baseline, 96 Days]

    6. Percentage of patients with serum total calcium above the upper limit of normal range [Over 96 days]

    7. Percentage of patients with serum total calcium more than 1 mg/dl above the upper limit of normal range [Over 96 days]

    8. Number of participants with hPTH (1-34) specific antibody immune response [Baseline, 96 days]

    9. Draize score for erythema and edema [Over 96 Days]

    10. Visual Analog Scale (VAS) pain assessment [Over 96 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    55 Years to 85 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Osteocentrum FN Hradec Kralove Czech Republic
    2 Osteocentrum 3 .Interni Klinika 1. LFUK a VFN Prague Czech Republic
    3 Drug Research Center Balatonfured Hungary
    4 Semmelweis University Department of Orthopedic Budapest Hungary
    5 Kenezy Gyula Hospital Department of Rheumatology Debrecen Hungary
    6 Szent Andras Hospital-Heviz Heviz Hungary
    7 Szent Ferenc Hospital Department of Rheumatology Miskolc Hungary
    8 Hillel Yafe Medical Center - Endocrinology dep Hadera Israel
    9 Rambam Medical Center Haifa Israel
    10 Hadassah Medical Center Osteoporosis Center Jerusalem Israel

    Sponsors and Collaborators

    • TransPharma Medical
    • Eli Lilly and Company

    Investigators

    • Study Director: Efrat Kochba, MD, TransPharma-Medical Ltd.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00535860
    Other Study ID Numbers:
    • CS 82-000-04
    • I2Y-MC-GHFE
    First Posted:
    Sep 26, 2007
    Last Update Posted:
    Jul 10, 2009
    Last Verified:
    Jul 1, 2009
    Keywords provided by , ,
    Osteoporosis
    Transdermal
    hPTH(1-34)
    Additional relevant MeSH terms:
    Osteoporosis
    Teriparatide

    Study Results

    No Results Posted as of Jul 10, 2009