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

Phase 2

Completed

• Conditions: Osteoporosis
• Interventions: Drug: Teriparatide

• Registration Number: NCT00535860
• Lead Sponsor: TransPharma Medical

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-09-25
• Study First Submitted QC: 2007-09-25
• Study First Posted: 2007-09-26
• Study Start: 2008-04
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Status Verified: 2009-07
• Last Update Submitted: 2009-07-09
• Last Update Posted: 2009-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 104

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
50 mcg	Teriparatide	ViaDerm transdermal delivery
80 mcg	Teriparatide	Add Via-Derm transdermal delivery
20 mcg	Teriparatide	Subcutaneous injection

Primary Outcome Measures

Name	Time	Method
Change from baseline to endpoint 96 days in procollagen 1 N-terminal propeptide (P1NP)	Baseline, 96 days

Secondary Outcome Measures

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

Trial Locations

Locations (10)

Osteocentrum 3 .Interni Klinika 1. LFUK a VFN; 🇨🇿 Prague, Czech Republic

Hillel Yafe Medical Center - Endocrinology dep; 🇮🇱 Hadera, Israel

Osteocentrum FN; 🇨🇿 Hradec Kralove, Czech Republic

Szent Ferenc Hospital Department of Rheumatology; 🇭🇺 Miskolc, Hungary

Semmelweis University Department of Orthopedic; 🇭🇺 Budapest, Hungary

Drug Research Center; 🇭🇺 Balatonfured, Hungary

Hadassah Medical Center Osteoporosis Center; 🇮🇱 Jerusalem, Israel

Kenezy Gyula Hospital Department of Rheumatology; 🇭🇺 Debrecen, Hungary

Szent Andras Hospital-Heviz; 🇭🇺 Heviz, Hungary

Rambam Medical Center; 🇮🇱 Haifa, Israel