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

Primary Purpose

Osteoporosis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Teriparatide
Sponsored by
TransPharma Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis focused on measuring Osteoporosis, Transdermal, hPTH(1-34)

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Osteocentrum FN
  • Osteocentrum 3 .Interni Klinika 1. LFUK a VFN
  • Drug Research Center
  • Semmelweis University Department of Orthopedic
  • Kenezy Gyula Hospital Department of Rheumatology
  • Szent Andras Hospital-Heviz
  • Szent Ferenc Hospital Department of Rheumatology
  • Hillel Yafe Medical Center - Endocrinology dep
  • Rambam Medical Center
  • Hadassah Medical Center Osteoporosis Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

50 mcg

80 mcg

20 mcg

Arm Description

ViaDerm transdermal delivery

Add Via-Derm transdermal delivery

Subcutaneous injection

Outcomes

Primary Outcome Measures

Change from baseline to endpoint 96 days in procollagen 1 N-terminal propeptide (P1NP)

Secondary Outcome Measures

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

Full Information

First Posted
September 25, 2007
Last Updated
July 9, 2009
Sponsor
TransPharma Medical
Collaborators
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00535860
Brief Title
Efficacy & Safety of ViaDerm-hPTH(1-34) Compared to Forteo SC in Postmenopausal Women With Osteoporosis
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
TransPharma Medical
Collaborators
Eli Lilly and Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
Osteoporosis, Transdermal, hPTH(1-34)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
50 mcg
Arm Type
Experimental
Arm Description
ViaDerm transdermal delivery
Arm Title
80 mcg
Arm Type
Experimental
Arm Description
Add Via-Derm transdermal delivery
Arm Title
20 mcg
Arm Type
Active Comparator
Arm Description
Subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Teriparatide
Other Intervention Name(s)
Forteo, Forsteo, LY333334
Intervention Description
Daily for 96 days
Primary Outcome Measure Information:
Title
Change from baseline to endpoint 96 days in procollagen 1 N-terminal propeptide (P1NP)
Time Frame
Baseline, 96 days
Secondary Outcome Measure Information:
Title
Change from baseline in C-terminal telopeptide of type I collagen (CTX-1.)
Time Frame
Baseline, 96 days
Title
hPTH (1-34) Pharmacokinetic AUC of ViaDerm-hPTH (1-34) and teriparatide SC.
Time Frame
Baseline, 96 days
Title
Ratio of hPTH (1-34) AUC of transdermal treatment and subcutaneous injection
Time Frame
Baseline, 96 days
Title
Ratio of hPTH (1-34) Cmax of transdermal treatment and subcutaneous injection
Time Frame
Baseline, 96 days
Title
hPTH (1-34) Pharmacokinetic Cmax of ViaDerm-hPTH (1-34) and teriparatide SC.
Time Frame
Baseline, 96 Days
Title
Percentage of patients with serum total calcium above the upper limit of normal range
Time Frame
Over 96 days
Title
Percentage of patients with serum total calcium more than 1 mg/dl above the upper limit of normal range
Time Frame
Over 96 days
Title
Number of participants with hPTH (1-34) specific antibody immune response
Time Frame
Baseline, 96 days
Title
Draize score for erythema and edema
Time Frame
Over 96 Days
Title
Visual Analog Scale (VAS) pain assessment
Time Frame
Over 96 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Efrat Kochba, MD
Organizational Affiliation
TransPharma-Medical Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Osteocentrum FN
City
Hradec Kralove
Country
Czech Republic
Facility Name
Osteocentrum 3 .Interni Klinika 1. LFUK a VFN
City
Prague
Country
Czech Republic
Facility Name
Drug Research Center
City
Balatonfured
Country
Hungary
Facility Name
Semmelweis University Department of Orthopedic
City
Budapest
Country
Hungary
Facility Name
Kenezy Gyula Hospital Department of Rheumatology
City
Debrecen
Country
Hungary
Facility Name
Szent Andras Hospital-Heviz
City
Heviz
Country
Hungary
Facility Name
Szent Ferenc Hospital Department of Rheumatology
City
Miskolc
Country
Hungary
Facility Name
Hillel Yafe Medical Center - Endocrinology dep
City
Hadera
Country
Israel
Facility Name
Rambam Medical Center
City
Haifa
Country
Israel
Facility Name
Hadassah Medical Center Osteoporosis Center
City
Jerusalem
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

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

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