DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: TransPharma Medical
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Osteoporosis

Intervention: Teriparatide (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: TransPharma Medical

Official(s) and/or principal investigator(s):
Efrat Kochba, MD, Study Director, Affiliation: TransPharma-Medical Ltd.

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

Clinical Details

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

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

Secondary outcome:

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

Eligibility

Minimum age: 55 Years. Maximum age: 85 Years. Gender(s): Female.

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

Locations and Contacts

Osteocentrum FN, Hradec Kralove, Czech Republic

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

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, Hungary

Hillel Yafe Medical Center - Endocrinology dep, Hadera, Israel

Rambam Medical Center, Haifa, Israel

Hadassah Medical Center Osteoporosis Center, Jerusalem, Israel

Additional Information

Starting date: April 2008
Last updated: July 9, 2009

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017