Efficacy & Safety of ViaDerm-hPTH(1-34) Compared to Forte... | NCT00535860

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

NCT00535860

Sponsor

TransPharma Medical

Status

Completed

Last Update Posted

Jul 10, 2009Estimated

Enrollment

104Actual

Phase

Phase 2

Conditions

Osteoporosis

Interventions

Teriparatide

Countries

Czechia
Hungary
Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
I2Y-MC-GHFE

Status Module

Record Verification Date

Jul 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2008

Primary Completion Date

Mar 2009Actual

Completion Date

Mar 2009Actual

First Submitted Date

Sep 25, 2007

First Submission Date that Met QC Criteria

Sep 25, 2007

First Posted Date

Sep 26, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 9, 2009

Last Update Posted Date

Jul 10, 2009Estimated

Name	Class
Eli Lilly and Company	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

104Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
50 mcg	Experimental	ViaDerm transdermal delivery	Drug: Teriparatide
80 mcg	Experimental	Add Via-Derm transdermal delivery	Drug: Teriparatide
20 mcg	Active Comparator	Subcutaneous injection	Drug: Teriparatide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Teriparatide	Drug	Daily for 96 days	20 mcg 50 mcg 80 mcg

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Efrat Kochba, MD	TransPharma-Medical Ltd.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Osteocentrum FN		Hradec Králové			Czechia
Osteocentrum 3 .Interni Klinika 1. LFUK a VFN

Condition Browse Module

MeSH Terms

ID	Term
D010024	Osteoporosis

Ancestor Terms

ID	Term
D001851	Bone Diseases, Metabolic
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019379	Teriparatide

Ancestor Terms

ID	Term
D010281	Parathyroid Hormone
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists

Browse Leaves

Not provided

Browse Branches

Not provided