The primary purpose of this study is to help answer the following research questions: 1. How teriparatide given using a skin patch (transferred through the skin using the ViaDerm Teriparatide System) compares to teriparatide injected under the skin with a needle (pen injector) affects your bone density (how solid or porous your bones are). 2. The safety of the teriparatide skin patch and any side effects that might be associated with it.
Teriparatide 20 micrograms (mcg) per day is currently only available as a subcutaneous (SQ) injection and many patients with severe osteoporosis for whom anabolic therapy with teriparatide is appropriate are either unwilling or physically unable to self-inject. The purpose of this Phase 2 study is to identify a transdermal dose or doses that will be comparable to the teriparatide 20 mcg SQ dose from a pharmacodynamic (PD) and safety standpoint for use in future Phase 3 studies.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
233
Administered subcutaneously once daily for 12 months
Administered transdermally, applied once daily for 6 hours over 12 months
Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 12 Months
Bone mineral density (BMD) of the lumbar spine was assessed by dual energy X-ray absorptiometry (DXA). BMD values are corrected data and have been standardized across the machine types (Hologic and Lunar). Analyses were performed using ANCOVA model and least square (LS) means were adjusted for baseline BMD values as a covariate and pooled site and treatment as fixed effects.
Time frame: Baseline, 12 Months
Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 6 Months
Bone mineral density (BMD) of the lumbar spine was assessed by dual energy X-ray absorptiometry (DXA). BMD values are corrected data and have been standardized across the machine types (Hologic and Lunar). Analyses were performed using ANCOVA model with the baseline value as a covariate and pooled site and treatment as fixed effects.
Time frame: Baseline, 6 Months
Time Course Change of BMD Response at the Lumbar Spine
To assess the time course of the treatment, the BMD data of the lumbar spine was assessed by dual energy X-ray absorptiometry (DXA) and analyzed using a mixed model repeated measures (MMRM) method, with the repeated measure occurring at each visit (for example, 6 and 12 month). BMD values are corrected data and have been standardized across the machine types (Hologic and Lunar).
Time frame: Baseline to 6 Months and 12 Months
Percent Change From Baseline in Procollagen Type 1 N-Terminal Propeptide (P1NP)
Procollagen Type 1 N-Terminal Propeptide (P1NP) is a marker of bone formation.
Time frame: Baseline, 1 Month, 3 Months, 6 Months, 12 Months
Percent Change From Baseline of C-Terminal Telopeptide (CTX)
C-terminal telopeptide is a marker of bone resorption.
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Buenos Aires, Argentina
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Pärnu, Estonia
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Tallinn, Estonia
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Tartu, Estonia
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Balatonfüred, Hungary
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Budapest, Hungary
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Debrecen, Hungary
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Esztergom, Hungary
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Győr, Hungary
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Szombathely, Hungary
...and 8 more locations
Time frame: Baseline, 1 Month, 3 Months, 6 Months, 12 Months
Percent Change From Baseline in Serum Procollagen Type 1 C-Propeptide (P1CP) at 1 Month
Procollagen Type 1 N-Terminal Propeptide (P1NP) is a marker of bone formation.
Time frame: Baseline, 1 Month
Convenience/Ease of Use Questionnaire (CEUQ)
CEUQ consists of 5 sections and 16 questions using a 5-point Likert scale designed to collect measures for ease of use (S1), convenience of use (S2), confidence of use (S3), fear of use (S4), and overall satisfaction with therapy (S5). CEUQ is not a validated instrument.
Time frame: baseline up to 12 months
Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours
Serum calcium adjusted for serum albumin levels is calculated using the following formula: Total Calcium + \[(40 - albumin) x 0.02\]. Analysis for serum calcium and albumin adjusted serum calcium were collected at predose, 4 hours (h) post-dose (PD) and 6 h PD at baseline and 12 months (mon).
Time frame: Baseline, 12 Months
Change From Baseline in Urine Calcium Excretion at 6 and 12 Months
Time frame: Baseline, 6 Months, 12 Months
Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon)
Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) measured at pre-dose and 30 minutes (min) and 2 hours (hr) post-dose in both the supine and standing position.
Time frame: Pre-Dose, 30 minutes, 2 hours Post-Dose at Baseline and 12 Months
Change From Pre-dose to Postdose in Supine and Standing Heart Rate at Baseline (BL) and 12 Months (Mon).
Time frame: Pre-dose, 30 minutes, 2 hours at Baseline and 12 Months
Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels
Participants were tested for anti-recombinant teriparatide and anti-synthetic teriparatide titers. Either none were detected (ND) or antibodies were determined to be present if the teriparatide specific antibody titers were at least 1:8 (titer 1:8).
Time frame: Baseline and 1, 3, 12, and 13 Months (mon)
Pharmacokinetics Parameters: Area Under the Curve (AUC)
Due to high intra-subject variability, data was not analyzed for this outcome measure.
Time frame: Baseline, 1 Month, 3 Months, and 12 Months
Pharmacokinetics Parameters: Maximal Concentration (Cmax)
Due to high intra-subject variability, data was not analyzed for this outcome measure.
Time frame: Baseline, 1 Month, 3 Months, 12 Months
DRAIZE Edema Assessment at Baseline Through 13 Month Follow-up
Severity of edema was categorized based on a 5 point scale: 0=no edema, 4=severe edema (defined as an area raised more than 1 millimeter and extending beyond area of exposure)
Time frame: 13 Month follow-up
DRAIZE Erythema Assessment at Baseline Through 13 Month Follow-up
Severity of erythema was categorized based on a 5 point scale: 0=no erythema, 4=severe erythema (defined as beet red to eschar)
Time frame: 13 Month follow-up