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

Osteoporosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00535860
• Other study ID #: CS 82-000-04
• Secondary ID: I2Y-MC-GHFE
• Status: Completed
• Phase: Phase 2
• First received: September 25, 2007
• Last updated: July 9, 2009
• Start date: April 2008
• Est. completion date: March 2009

Study information

• Verified date: July 2009
• Source: TransPharma Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: The Israel National Institute for Health Policy Research and Health Services ResearchEuropean Union: European Medicines AgencyCzech Republic: State Institute for Drug ControlHungary: National Institute of Pharmacy
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• Teriparatide
Daily for 96 days

Locations

Country	Name	City	State
Czech Republic	Osteocentrum FN	Hradec Kralove
Czech Republic	Osteocentrum 3 .Interni Klinika 1. LFUK a VFN	Prague
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
Israel	Hillel Yafe Medical Center - Endocrinology dep	Hadera
Israel	Rambam Medical Center	Haifa
Israel	Hadassah Medical Center Osteoporosis Center	Jerusalem

Sponsors (2)

Lead Sponsor	Collaborator
TransPharma Medical	Eli Lilly and Company

Countries where clinical trial is conducted

Czech Republic,  Hungary,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to endpoint 96 days in procollagen 1 N-terminal propeptide (P1NP)		Baseline, 96 days	No
Secondary	Change from baseline in C-terminal telopeptide of type I collagen (CTX-1.)		Baseline, 96 days	No
Secondary	hPTH (1-34) Pharmacokinetic AUC of ViaDerm-hPTH (1-34) and teriparatide SC.		Baseline, 96 days	No
Secondary	Ratio of hPTH (1-34) AUC of transdermal treatment and subcutaneous injection		Baseline, 96 days	No
Secondary	Ratio of hPTH (1-34) Cmax of transdermal treatment and subcutaneous injection		Baseline, 96 days	No
Secondary	hPTH (1-34) Pharmacokinetic Cmax of ViaDerm-hPTH (1-34) and teriparatide SC.		Baseline, 96 Days	No
Secondary	Percentage of patients with serum total calcium above the upper limit of normal range		Over 96 days	Yes
Secondary	Percentage of patients with serum total calcium more than 1 mg/dl above the upper limit of normal range		Over 96 days	Yes
Secondary	Number of participants with hPTH (1-34) specific antibody immune response		Baseline, 96 days	Yes
Secondary	Draize score for erythema and edema		Over 96 Days	Yes
Secondary	Visual Analog Scale (VAS) pain assessment		Over 96 days	Yes