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
  Purpose

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 Intervention Phase
Osteoporosis
Drug: Teriparatide
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by TransPharma Medical:

Primary Outcome Measures:
  • Change from baseline to endpoint 96 days in procollagen 1 N-terminal propeptide (P1NP) [ Time Frame: Baseline, 96 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 104
Study Start Date: April 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00535860

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

No publications provided

Responsible Party: Efrat Kochba, TransPharma Medical Ltd.
ClinicalTrials.gov Identifier: NCT00535860     History of Changes
Other Study ID Numbers: CS 82-000-04, I2Y-MC-GHFE
Study First Received: September 25, 2007
Last Updated: July 9, 2009
Health Authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research
European Union: European Medicines Agency
Czech Republic: State Institute for Drug Control
Hungary: National Institute of Pharmacy

Keywords provided by TransPharma Medical:
Osteoporosis
Transdermal
hPTH(1-34)

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 April 16, 2014