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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Osteoporosis

Intervention / Treatment
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* Drug: Teriparatide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 50 mcg<br>ViaDerm transdermal delivery | Drug: Teriparatide<br>* Daily for 96 days<br>* Other names: LY333334;|
| Experimental: 80 mcg<br>Add Via-Derm transdermal delivery | Drug: Teriparatide<br>* Daily for 96 days<br>* Other names: LY333334;|
| Active Comparator: 20 mcg<br>Subcutaneous injection | Drug: Teriparatide<br>* Daily for 96 days<br>* Other names: LY333334;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to endpoint 96 days in procollagen 1 N-terminal propeptide (P1NP) |  | Baseline, 96 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in C-terminal telopeptide of type I collagen (CTX-1.) |  | Baseline, 96 days | 
| hPTH (1-34) Pharmacokinetic AUC of ViaDerm-hPTH (1-34) and teriparatide SC. |  | Baseline, 96 days | 
| Ratio of hPTH (1-34) AUC of transdermal treatment and subcutaneous injection |  | Baseline, 96 days | 
| Ratio of hPTH (1-34) Cmax of transdermal treatment and subcutaneous injection |  | Baseline, 96 days | 
| hPTH (1-34) Pharmacokinetic Cmax of ViaDerm-hPTH (1-34) and teriparatide SC. |  | Baseline, 96 Days | 
| Percentage of patients with serum total calcium above the upper limit of normal range |  | Over 96 days | 
| Percentage of patients with serum total calcium more than 1 mg/dl above the upper limit of normal range |  | Over 96 days | 
| Number of participants with hPTH (1-34) specific antibody immune response |  | Baseline, 96 days | 
| Draize score for erythema and edema |  | Over 96 Days | 
| Visual Analog Scale (VAS) pain assessment |  | Over 96 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoporosis, Transdermal, hPTH(1-34)