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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 16, 2014