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

July 9, 2009 updated by: TransPharma Medical

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Hradec Kralove, Czech Republic
        • Osteocentrum FN
      • Prague, Czech Republic
        • Osteocentrum 3 .Interni Klinika 1. LFUK a VFN
  • Hungary
      • Balatonfured, Hungary
        • Drug Research Center
      • Budapest, Hungary
        • Semmelweis University Department of Orthopedic
      • Debrecen, Hungary
        • Kenezy Gyula Hospital Department of Rheumatology
      • Heviz, Hungary
        • Szent Andras Hospital-Heviz
      • Miskolc, Hungary
        • Szent Ferenc Hospital Department of Rheumatology
  • Israel
      • Hadera, Israel
        • Hillel Yafe Medical Center - Endocrinology dep
      • Haifa, Israel
        • Rambam Medical Center
      • Jerusalem, Israel
        • Hadassah Medical Center Osteoporosis Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 50 mcg
ViaDerm transdermal delivery
Drug: Teriparatide
Daily for 96 days
Other Names:
  • Forteo
  • LY333334
  • Forsteo
Experimental: 80 mcg
Add Via-Derm transdermal delivery
Drug: Teriparatide
Daily for 96 days
Other Names:
  • Forteo
  • LY333334
  • Forsteo
Active Comparator: 20 mcg
Subcutaneous injection
Drug: Teriparatide
Daily for 96 days
Other Names:
  • Forteo
  • LY333334
  • Forsteo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline to endpoint 96 days in procollagen 1 N-terminal propeptide (P1NP)
Time Frame: Baseline, 96 days
Baseline, 96 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in C-terminal telopeptide of type I collagen (CTX-1.)
Time Frame: Baseline, 96 days
Baseline, 96 days
hPTH (1-34) Pharmacokinetic AUC of ViaDerm-hPTH (1-34) and teriparatide SC.
Time Frame: Baseline, 96 days
Baseline, 96 days
Ratio of hPTH (1-34) AUC of transdermal treatment and subcutaneous injection
Time Frame: Baseline, 96 days
Baseline, 96 days
Ratio of hPTH (1-34) Cmax of transdermal treatment and subcutaneous injection
Time Frame: Baseline, 96 days
Baseline, 96 days
hPTH (1-34) Pharmacokinetic Cmax of ViaDerm-hPTH (1-34) and teriparatide SC.
Time Frame: Baseline, 96 Days
Baseline, 96 Days
Percentage of patients with serum total calcium above the upper limit of normal range
Time Frame: Over 96 days
Over 96 days
Percentage of patients with serum total calcium more than 1 mg/dl above the upper limit of normal range
Time Frame: Over 96 days
Over 96 days
Number of participants with hPTH (1-34) specific antibody immune response
Time Frame: Baseline, 96 days
Baseline, 96 days
Draize score for erythema and edema
Time Frame: Over 96 Days
Over 96 Days
Visual Analog Scale (VAS) pain assessment
Time Frame: Over 96 days
Over 96 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TransPharma Medical

Collaborators

Eli Lilly and Company

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

September 25, 2007

First Submitted That Met QC Criteria

September 25, 2007

First Posted (Estimate)

September 26, 2007

Study Record Updates

Last Update Posted (Estimate)

July 10, 2009

Last Update Submitted That Met QC Criteria

July 9, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CS 82-000-04
  • I2Y-MC-GHFE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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