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
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