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

TransPharma Medical104 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

104

Conditions

Osteoporosis

Interventions

TeriparatideDRUG

Daily for 96 days

Eligibility

Sex: FEMALEMin age: 55 YearsMax age: 85 Years

Medical Language ↔ Plain English

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 (10)

Osteocentrum FN

Hradec Králové, Czechia

Osteocentrum 3 .Interni Klinika 1. LFUK a VFN

Prague, Czechia

Drug Research Center

Balatonfüred, Hungary

Semmelweis University Department of Orthopedic

Outcomes

Primary Outcomes

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

Time frame: Baseline, 96 days

Secondary Outcomes

Change from baseline in C-terminal telopeptide of type I collagen (CTX-1.)

Time frame: Baseline, 96 days

hPTH (1-34) Pharmacokinetic AUC of ViaDerm-hPTH (1-34) and teriparatide SC.

Time frame: Baseline, 96 days

Ratio of hPTH (1-34) AUC of transdermal treatment and subcutaneous injection

Time frame: Baseline, 96 days

Ratio of hPTH (1-34) Cmax of transdermal treatment and subcutaneous injection

Time frame: Baseline, 96 days

hPTH (1-34) Pharmacokinetic Cmax of ViaDerm-hPTH (1-34) and teriparatide SC.

Time frame: Baseline, 96 Days

Percentage of patients with serum total calcium above the upper limit of normal range

Time frame: Over 96 days

Percentage of patients with serum total calcium more than 1 mg/dl above the upper limit of normal range

Time frame: Over 96 days

Number of participants with hPTH (1-34) specific antibody immune response

Time frame: Baseline, 96 days

Draize score for erythema and edema

Time frame: Over 96 Days

Visual Analog Scale (VAS) pain assessment

Data from ClinicalTrials.gov

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