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

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:

MedlinePlus related topics: Osteoporosis

Drug Information available for: Teriparatide Teriparatide acetate

U.S. FDA Resources

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 May 19, 2013