Clinical trial NCT00535860: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoporosis
Keywords: Osteoporosis
Transdermal
hPTH(1-34)
Lead sponsor: TransPharma Medical
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2007-09-26
Enrollment: 104
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Change from baseline to endpoint 96 days in procollagen 1 N-terminal propeptide (P1NP)
timeFrame: Baseline, 96 days
Secondary outcomes:
measure: Change from baseline in C-terminal telopeptide of type I collagen (CTX-1.)
timeFrame: Baseline, 96 days
measure: hPTH (1-34) Pharmacokinetic AUC of ViaDerm-hPTH (1-34) and teriparatide SC.
timeFrame: Baseline, 96 days
measure: Ratio of hPTH (1-34) AUC of transdermal treatment and subcutaneous injection
timeFrame: Baseline, 96 days
measure: Ratio of hPTH (1-34) Cmax of transdermal treatment and subcutaneous injection
timeFrame: Baseline, 96 days
measure: hPTH (1-34) Pharmacokinetic Cmax of ViaDerm-hPTH (1-34) and teriparatide SC.
timeFrame: Baseline, 96 Days
measure: Percentage of patients with serum total calcium above the upper limit of normal range
timeFrame: Over 96 days
measure: Percentage of patients with serum total calcium more than 1 mg/dl above the upper limit of normal range
timeFrame: Over 96 days
measure: Number of participants with hPTH (1-34) specific antibody immune response
timeFrame: Baseline, 96 days
measure: Draize score for erythema and edema
timeFrame: Over 96 Days
measure: Visual Analog Scale (VAS) pain assessment
timeFrame: Over 96 days
Other outcomes:
Locations:
city: Hradec Kralove
country: Czech Republic
facility: Osteocentrum FN
city: Prague
country: Czech Republic
facility: Osteocentrum 3 .Interni Klinika 1. LFUK a VFN
city: Balatonfured
country: Hungary
facility: Drug Research Center
city: Budapest
country: Hungary
facility: Semmelweis University Department of Orthopedic
city: Debrecen
country: Hungary
facility: Kenezy Gyula Hospital Department of Rheumatology
city: Heviz
country: Hungary
facility: Szent Andras Hospital-Heviz
city: Miskolc
country: Hungary
facility: Szent Ferenc Hospital Department of Rheumatology
city: Hadera
country: Israel
facility: Hillel Yafe Medical Center - Endocrinology dep
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Medical Center Osteoporosis Center
Study officials:
affiliation: TransPharma-Medical Ltd.
name: Efrat Kochba, MD
role: STUDY_DIRECTOR
References: