Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| I2Y-MC-GHFA(c) | Other Identifier | Eli Lilly and Company |
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| TransPharma Medical | INDUSTRY |
Not provided
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Not provided
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The primary purpose of this study is to help answer the following research questions:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 20 mcg Subcutaneous Teriparatide | Active Comparator | Received 20 micrograms (mcg) subcutaneously once daily in an unblinded manner. |
|
| 30 mcg Transdermal Teriparatide | Experimental | Received 30 micrograms (mcg) teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level. |
|
| 50 mcg Transdermal Teriparatide | Experimental | Received 50 micrograms (mcg) teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level. |
|
| 80 mcg Transdermal Teriparatide | Experimental | Received 80 micrograms (mcg) teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Subcutaneous Teriparatide | Drug | Administered subcutaneously once daily for 12 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Treatment with:
Not provided
Not provided
Not provided
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Not provided
| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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 | C1128AAF |
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| ID | Title | Description |
|---|---|---|
| FG000 | 20 Mcg Subcutaneous Teriparatide | Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner. |
| FG001 | 30 Mcg Transdermal Teriparatide | Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level. |
| FG002 | 50 Mcg Transdermal Teriparatide | Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level. |
| FG003 | 80 Mcg Transdermal Teriparatide | Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 20 Mcg Subcutaneous Teriparatide | Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner. |
| BG001 | 30 Mcg Transdermal Teriparatide |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All participants who received at least 1 dose of drug and had at least 1 baseline and post-baseline lumbar spine BMD measure. Analysis was performed using intention-to-treat (ITT) principle, last observation carried forward method and ANCOVA model. | Posted | Least Squares Mean | 90% Confidence Interval | percentage change in BMD | Baseline, 12 Months |
|
Not provided
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 20 Mcg Subcutaneous Teriparatide | Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haemorrhagic anaemia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
Not provided
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D010281 | Parathyroid Hormone |
| D019379 | Teriparatide |
| ID | Term |
|---|---|
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
Not provided
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Not provided
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| Transdermal Teriparatide | Drug | Administered transdermally, applied once daily for 6 hours over 12 months |
|
|
| 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). | 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. | 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. | 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. | 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. | 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). | Baseline, 12 Months |
| Change From Baseline in Urine Calcium Excretion at 6 and 12 Months | 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. | 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). | 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). | 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. | 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. | 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) | 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) | 13 Month follow-up |
| Argentina |
| 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. | Pärnu | 80010 | Estonia |
| 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. | Tallinn | 10138 | Estonia |
| 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. | Tartu | 50410 | Estonia |
| 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. | Balatonfüred | 8230 | 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. | Budapest | 1036 | 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 | 4043 | 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. | Esztergom | 2500 | 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 | 9023 | 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 | H-9700 | 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. | Tatabánya | 2800 | 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. | Guadalajara | 44158 | Mexico |
| 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. | Mexico City | 03300 | Mexico |
| 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. | Monterrey | 64460 | Mexico |
| 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. | Bucharest | 011025 | Romania |
| 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. | Cluj-Napoca | 400006 | Romania |
| 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. | Lasi | 700111 | Romania |
| 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. | Timișoara | 300736 | Romania |
| Lost to Follow-up |
|
| Physician Decision |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Sponsor decision |
|
| Inclusion/exclusion criteria not met |
|
Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
| BG002 | 50 Mcg Transdermal Teriparatide | Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level. |
| BG003 | 80 Mcg Transdermal Teriparatide | Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 30 Mcg Transdermal Teriparatide | Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level. |
| OG002 | 50 Mcg Transdermal Teriparatide | Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level. |
| OG003 | 80 Mcg Transdermal Teriparatide | Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level. |
|
|
|
| Secondary | 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. | All participants who received at least 1 dose of drug and had at least 1 baseline and post-baseline lumbar spine BMD measure. Analysis was performed using intent-to-treat principal, last observation carried forward method and ANCOVA model. | Posted | Least Squares Mean | 90% Confidence Interval | percentage change in BMD | Baseline, 6 Months |
|
|
|
|
| Secondary | 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). | All participants who received at least 1 dose of drug, had at least 1 baseline and post-baseline lumbar spine BMD measure. Analysis was performed using ITT principal. | Posted | Least Squares Mean | 90% Confidence Interval | percentage change in BMD | Baseline to 6 Months and 12 Months |
|
|
|
|
| Secondary | 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. | All randomized participants who received at least one dose of study drug. The intent-to-treat principle was applied. | Posted | Mean | Standard Deviation | percentage change in P1NP | Baseline, 1 Month, 3 Months, 6 Months, 12 Months |
|
|
|
|
| Secondary | Percent Change From Baseline of C-Terminal Telopeptide (CTX) | C-terminal telopeptide is a marker of bone resorption. | All randomized participants who received at least one dose of study drug. The intent-to-treat principle was applied. | Posted | Mean | Standard Deviation | percentage change in CTX | Baseline, 1 Month, 3 Months, 6 Months, 12 Months |
|
|
|
|
| Secondary | 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. | All randomized participants who received at least one dose of study drug. The intent-to-treat principle was applied. | Posted | Median | Standard Deviation | percentage change in P1CP | Baseline, 1 Month |
|
|
|
|
| Secondary | 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. | All randomized participants who received at least 1 dose of study drug and had CEUQ assessment. Last observation was carried forward, unless the last observation was also the first completed questionnaire. | Posted | Number | participants | baseline up to 12 months |
|
|
|
| Secondary | 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). | All randomized participants who received at least 1 dose of study drug and had serum calcium measurements or adjusted serum calcium measurements at the indicated timepoint. | Posted | Mean | Standard Deviation | millimole/Liter (mmol/L) | Baseline, 12 Months |
|
|
|
| Secondary | Change From Baseline in Urine Calcium Excretion at 6 and 12 Months | All randomized participants who received at least 1 dose of study drug and had urine calcium measurements at the indicated timepoint. | Posted | Mean | Standard Deviation | millimole/day (mmol/day) | Baseline, 6 Months, 12 Months |
|
|
|
| Secondary | 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. | All randomized participants who received at least 1 dose of study drug and had predose and postdose blood pressure measurements at the indicated timepoint and body position. | Posted | Mean | Standard Deviation | mmHg | Pre-Dose, 30 minutes, 2 hours Post-Dose at Baseline and 12 Months |
|
|
|
| Secondary | Change From Pre-dose to Postdose in Supine and Standing Heart Rate at Baseline (BL) and 12 Months (Mon). | All randomized participants who received at least 1 dose of study drug and had predose and postdose heart rate measurements at the indicated timepoint and body position. | Posted | Mean | Standard Deviation | beats per minute (bpm) | Pre-dose, 30 minutes, 2 hours at Baseline and 12 Months |
|
|
|
| Secondary | 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). | All randomized participants who received at least one dose of study drug and had antibody results. | Posted | Number | participants | Baseline and 1, 3, 12, and 13 Months (mon) |
|
|
|
| Secondary | Pharmacokinetics Parameters: Area Under the Curve (AUC) | Due to high intra-subject variability, data was not analyzed for this outcome measure. | Due to high intra-subject variability, zero participants were analyzed on this outcome measure. | Posted | Baseline, 1 Month, 3 Months, and 12 Months |
|
|
| Secondary | Pharmacokinetics Parameters: Maximal Concentration (Cmax) | Due to high intra-subject variability, data was not analyzed for this outcome measure. | Due to high intra-subject variability, zero participants were analyzed for this outcome measure. | Posted | Baseline, 1 Month, 3 Months, 12 Months |
|
|
| Secondary | 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) | All randomized participants who received at least 1 dose of study drug and had edema measurements at 13 months. | Posted | Number | participants | 13 Month follow-up |
|
|
|
| Secondary | 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) | All randomized participants who received at least 1 dose of study drug and had erythema measurements at 13 months. | Posted | Number | participants | 13 Month follow-up |
|
|
|
| 2 |
| 57 |
| 30 |
| 57 |
| EG001 | 30 Mcg Transdermal Teriparatide | Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level. | 2 | 56 | 33 | 56 |
| EG002 | 50 Mcg Transdermal Teriparatide | Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level. | 1 | 54 | 30 | 54 |
| EG003 | 80 Mcg Transdermal Teriparatide | Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level. | 5 | 64 | 39 | 64 |
| Colonic polyp | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Diverticulum intestinal | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Lobar pneumonia | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
|
| Metastatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA 14.1 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA 14.1 | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA 14.1 | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA 14.1 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Application site discolouration | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
|
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
|
| Subcutaneous haematoma | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
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| Sciatica | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
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| Hypercalciuria | Renal and urinary disorders | MedDRA 14.1 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
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| Intra-abdominal haematoma | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
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Not provided
| D009750 |
| Nutritional and Metabolic Diseases |
| D000602 | Amino Acids, Peptides, and Proteins |
Analyses were performed using ANCOVA model with the baseline value as a covariate and pooled site and treatment as fixed effects. |
| <0.001 |
| Difference in Least Square Means |
| -3.87 |
| 2-Sided |
| 90 |
| -5.006 |
| -2.727 |
| No |
| Superiority or Other |
| ANCOVA | Analyses were performed using ANCOVA model with the baseline value as a covariate and pooled site and treatment as fixed effects. | <0.001 | Difference in Least Square Means | -3.56 | 2-Sided | 90 | -4.652 | -2.464 | No | Superiority or Other |
| 12 months (n=52, 48, 45, 50) |
|
| Mixed Models Analysis |
MMRM Model: Percentage change in BMD = treatment+baseline+pooled site+visit+treatment*visit interaction. Repeat measure occurred at each visit. |
| <0.001 |
p-value is for change in BMD at 6 months |
| Difference in Least Square Means |
| -3.94 |
| Standard Error of the Mean |
| 0.692 |
| 2-Sided |
| 90 |
| -5.086 |
| -2.800 |
| No |
| Superiority or Other |
| Mixed Models Analysis | MMRM Model: Percentage change in BMD = treatment+baseline+pooled site+visit+treatment*visit interaction. Repeat measure occurred at each visit. | <0.001 | p-value is for change in BMD at 6 months | Difference in Least Square Means | -3.53 | Standard Error of the Mean | 0.665 | 2-Sided | 90 | -4.627 | -2.430 | No | Superiority or Other |
| Mixed Models Analysis | MMRM Model: Percentage change in BMD = treatment+baseline+pooled site+visit+treatment*visit interaction. Repeat measure occurred at each visit. | <0.001 | p-value is for change in BMD at 12 months | Difference in Least Square Means | -7.50 | Standard Error of the Mean | 0.818 | 2-Sided | 90 | -8.856 | -6.151 | No | Superiority or Other |
| Mixed Models Analysis | MMRM Model: Percentage change in BMD = treatment+baseline+pooled site+visit+treatment*visit interaction. Repeat measure occurred at each visit. | 0.001 | p-value for change in BMD at 12 months | Difference in Least Square Means | -7.46 | Standard Error of the Mean | 0.830 | 2-Sided | 90 | -8.835 | -6.091 | No | Superiority or Other |
| Mixed Models Analysis | MMRM Model: Percentage change in BMD = treatment+baseline+pooled site+visit+treatment*visit interaction. Repeat measure occurred at each visit. | 0.001 | p-value is for change in BMD at 12 months | Difference in Least Square Means | -6.19 | Standard Error of the Mean | 0.802 | 2-Sided | 90 | -7.510 | -4.860 | No | Superiority or Other |
| 3 months (n=50, 51, 49, 59) |
|
| 6 months (n=48, 49, 48, 56) |
|
| 12 months (n=47, 46, 43, 49) |
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| <0.001 |
| 95 |
| No |
| Superiority or Other |
| Wilcoxon Rank Sum Test | Pairwise comparison p-value at 1 month. | <0.001 | 95 | No | Superiority or Other |
| Wilcoxon Rank Sum Test | Pairwise comparison p-value at 3 months. | <0.001 | 95 | No | Superiority or Other |
| Wilcoxon Rank Sum Test | Pairwise comparison p-value at 3 months. | <0.001 | 95 | No | Superiority or Other |
| Wilcoxon Rank Sum Test | Pairwise comparison p-value at 3 months. | 0.003 | 95 | No | Superiority or Other |
| Wilcoxon Rank Sum Test | Pairwise comparison p-value at 6 months. | <0.001 | 95 | No | Superiority or Other |
| Wilcoxon Rank Sum Test | Pairwise comparison p-value at 6 months. | <0.001 | 95 | No | Superiority or Other |
| Wilcoxon Rank Sum Test | Pairwise comparison p-value at 6 months. | 0.029 | 95 | No | Superiority or Other |
| Wilcoxon Rank Sum Test | Pairwise comparison p-value at 12 months. | <0.001 | 95 | No | Superiority or Other |
| Wilcoxon Rank Sum Test | Pairwise comparison p-value at 12 months. | <0.001 | 95 | No | Superiority or Other |
| Wilcoxon Rank Sum Test | Pairwise comparison p-value at 12 months. | 0.047 | 95 | No | Superiority or Other |
| 3 months (n=50, 51, 49, 59) |
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| 6 months (n=48, 49, 48, 56) |
|
| 12 months (n=47, 46, 43, 49) |
|
| 0.406 |
| 95 |
| No |
| Superiority or Other |
| Wilcoxon Rank Sum Test | Pairwise comparison p-value at 1 month. | 0.312 | 95 | No | Superiority or Other |
| Wilcoxon Rank Sum Test | Pairwise comparison p-value at 3 months. | <0.001 | 95 | No | Superiority or Other |
| Wilcoxon Rank Sum Test | Pairwise comparison p-value at 3 months. | <0.001 | 95 | No | Superiority or Other |
| Wilcoxon Rank Sum Test | Pairwise comparison p-value at 3 months. | 0.952 | 95 | No | Superiority or Other |
| Wilcoxon Rank Sum Test | Pairwise comparison p-value at 6 months. | <0.001 | 95 | No | Superiority or Other |
| Wilcoxon Rank Sum Test | Pairwise comparison p-value at 6 months. | 0.011 | 95 | No | Superiority or Other |
| Wilcoxon Rank Sum Test | Pairwise comparison p-value at 6 months. | 0.997 | 95 | No | Superiority or Other |
| Wilcoxon Rank Sum Test | Pairwise comparison p-value at 12 months. | 0.003 | 95 | No | Superiority or Other |
| Wilcoxon Rank Sum Test | Pairwise comparison p-value at 12 months. | 0.112 | 95 | No | Superiority or Other |
| Wilcoxon Rank Sum Test | Pairwise comparison p-value at 12 months. | 0.988 | 95 | No | Superiority or Other |
| <0.001 |
| 95 |
| No |
| Superiority or Other |
| Wilcoxon Rank Sum Test | Pairwise comparison p-value at 1 month. | <0.001 | 95 | No | Superiority or Other |
| S1-Somewhat Disagree |
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| S1-Neutral |
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| S1-Somewhat Agree |
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| S1-Strongly Agree |
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| S2-Strongly Disagree |
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| S2-Somewhat Disagree |
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| S2-Neutral |
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| S2-Somewhat Agree |
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| S2-Strongly Agree |
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| S3-Not Confident |
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| S3-Somewhat Not Confident |
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| S3-Neutral |
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| S3-Somewhat Confident |
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| S3-Very Confident |
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| S4-Extremely Fearful |
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| S4-Somewhat Fearful |
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| S4-Neutral |
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| S4-Somewhat Not Fearful |
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| S4-Not Fearful |
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| S5-Very Dissatisfied |
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| S5-Somewhat Dissatisfied |
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| S5-Neutral |
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| S5-Somewhat Satisfied |
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| S5-Very Satisfied |
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| Baseline- 4 h PD; no adjustment (n=55,53,51,63) |
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| Baseline- 6 h PD; no adjustment (n=52,51,48,59) |
|
| 12 mon-predose; no adjustment (n=52,47,45,50) |
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| 12 mon-4 h PD; no adjustment (n=51,46,44,51) |
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| 12 mon-6 h PD; no adjustment (n=50,45,44,51) |
|
| baseline-predose albumin adjusted (n=53,53,50,60) |
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| baseline-4 h PD; albumin adjusted (n=52,52,50,61) |
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| baseline-6 h PD; albumin adjusted (n=49,50,47,57) |
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| 12 mon- predose albumin adjusted (n=52,47,45,50) |
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| 12 mon- 4 h PD; albumin adjusted (n=51,46,44,51) |
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| 12 mon-6 h PD; albumin adjusted (n=52,47,45,50) |
|
| 6 months (n=54, 50, 49, 56) |
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| 12 months (n=51, 47, 41, 51) |
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| BL, supine, SBP, 2 h (n=56,56,53,63) |
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| BL, supine, DBP, 30 min (n=56,54,51,62) |
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| BL, supine, DBP, 2 h (n=56,56,53,63) |
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| 12mon, supine, SBP, 30min (n=51,47,44,51) |
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| 12mon, supine, SBP, 2 h (n=51,47,44,51) |
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| 12mon, supine, DBP, 30min (n=52,48,45,51) |
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| 12mon, supine, DBP, 2 h (n=51,47,44,51) |
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| BL, standing, SBP, 30 min (n=56,54,51,62) |
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| BL, standing, SBP, 2 h (n=56,56,53,64) |
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| BL, standing, DBP, 30 min (n=56,54,51,62) |
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| BL, standing, DBP, 2 h (n=56,56,53,64) |
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| 12mon, standing, SBP, 30min(n=51,47,44,51) |
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| 12mon, standing, SBP, 2 h (n=51,47,44,51) |
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| 12mon, standing, DBP, 30 min(n=51,47,44,51 |
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| 12mon, standing, DBP, 2 h (n=51,47,44,51) |
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| BL, supine, 2 h (n=56,56,53,63) |
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| BL, standing, 30 min (n=56,54,51,62) |
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| BL, standing, 2 h (n=56,56,53,64) |
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| 12 mon, supine, 30 min (n=51,47,44,51) |
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| 12 mon, supine, 2 h (n=51,47,44,51) |
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| 12 mon, standing, 30 min (n=51,47,44,51) |
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| 12 mon, standing, 2 h (n=51,47,44,51) |
|
| Baseline:anti-recombinant titer 1:8(n=57,54,53,64) |
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| 1 mon:anti-recombinant ND (n=54,54,51,62) |
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| 1 mon:anti-recombinant titer 1:8 (n=54,54,51,62 |
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| 3 mon:anti-recombinant ND (n=55,52,51,61) |
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| 3 mon:anti-recombinant titer 1:8 (n=55,52,51,6 |
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| 12 mon:anti-recombinant ND (n=52,48,45,51) |
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| 12 mon:anti-recombinant titer 1:8 (n=52,48,45,51) |
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| 13 mon:anti-recombinant ND (n=50,46,44,50) |
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| 13 mon:anti-recombinant titer 1:8 (n=50,46,44,50) |
|
| Baseline:anti-synthetic ND (n=57,54,53,64) |
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| Baseline:anti-synthetic titer 1:8 (n=57,54,53,64) |
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| 1 mon:anti-synthetic ND (N=54,54,51,62) |
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| 1 mon:anti-synthetic titer 1:8 (N=54,54,51,62) |
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| 3 mon:anti-synthetic ND (n=55,52,51,61) |
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| 3 mon:anti-synthetic titer 1:8 (n=55,52,51,61) |
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| 12 mon:anti-synthetic ND (n=52,48,45,51) |
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| 12 mon:anti-synthetic titer 18 (n=52,48,45,51) |
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| 13 mon:anti-synthetic ND (n=50,46,44,50) |
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| 13 mon:anti-synthetic titer 1:8 (n=50,46,44,50) |
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| 1=very slight edema to 4=severe edema |
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| 1=very slight erythema to 4=severe erythema |
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