NCT00535860

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2008

Shorter than P25 for phase_2

Geographic Reach
3 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 26, 2007

Completed
6 months until next milestone

Study Start

First participant enrolled

April 1, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

July 10, 2009

Status Verified

July 1, 2009

Enrollment Period

11 months

First QC Date

September 25, 2007

Last Update Submit

July 9, 2009

Conditions

Osteoporosis

Keywords

OsteoporosisTransdermalhPTH(1-34)

Outcome Measures

Primary Outcomes (1)

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

    Baseline, 96 days

Secondary Outcomes (10)

  • 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

  • +5 more secondary outcomes

Study Arms (3)

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

TeriparatideDRUG

Daily for 96 days

Also known as: Forteo, Forsteo, LY333334
20 mcg50 mcg80 mcg

Eligibility Criteria

Age55 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (10)

Osteocentrum FN

Hradec Králové, Czechia

Location

Osteocentrum 3 .Interni Klinika 1. LFUK a VFN

Prague, Czechia

Location

Drug Research Center

Balatonfüred, Hungary

Location

Semmelweis University Department of Orthopedic

Budapest, Hungary

Location

Kenezy Gyula Hospital Department of Rheumatology

Debrecen, Hungary

Location

Szent Andras Hospital-Heviz

Hévíz, Hungary

Location

Szent Ferenc Hospital Department of Rheumatology

Miskolc, Hungary

Location

Hillel Yafe Medical Center - Endocrinology dep

Hadera, Israel

Location

Rambam Medical Center

Haifa, Israel

Location

Hadassah Medical Center Osteoporosis Center

Jerusalem, Israel

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

Teriparatide

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Parathyroid HormonePeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Efrat Kochba, MD

    TransPharma-Medical Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 25, 2007

First Posted

September 26, 2007

Study Start

April 1, 2008

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

July 10, 2009

Record last verified: 2009-07

Locations

IL(3)CZ(2)HU(5)