Osteoporosis
Conditions
Keywords
Osteoporosis, Transdermal, hPTH(1-34)
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
Interventions
DRUGTeriparatide
Daily for 96 days
Sponsors
Eli Lilly and Company
TransPharma Medical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
55 Years to 85 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to endpoint 96 days in procollagen 1 N-terminal propeptide (P1NP) | Baseline, 96 days |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Change from baseline in C-terminal telopeptide of type I collagen (CTX-1.) | Baseline, 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 |
| Percentage of patients with serum total calcium above the upper limit of normal range | Over 96 days |
Countries
Czechia, Hungary, Israel
Outcome results
None listed