Trial · NCT01011556
A Study for the Transdermal Application of Teriparatide
NCT01011556, Phase 2, Completed, Eli Lilly and Company; results first posted 2012-10-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study for the Transdermal Application of Teriparatide. Trials, record NCT01011556. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01011556
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study for the Transdermal Application of Teriparatide
- NCT number
- NCT01011556
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 233 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Osteoporosis
- Interventions
- Subcutaneous Teriparatide, Transdermal Teriparatide
- First posted
- 2009-11-11
- Last updated
- 2012-10-23
- Results first posted
- 2012-10-23
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 12 Months | Baseline, 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. |
| Secondary | Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 6 Months | Baseline, 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. |
| Secondary | Time Course Change of BMD Response at the Lumbar Spine | Baseline to 6 Months and 12 Months | 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). |
| Secondary | Percent Change From Baseline in Procollagen Type 1 N-Terminal Propeptide (P1NP) | Baseline, 1 Month, 3 Months, 6 Months, 12 Months | Procollagen Type 1 N-Terminal Propeptide (P1NP) is a marker of bone formation. |
| Secondary | Percent Change From Baseline of C-Terminal Telopeptide (CTX) | Baseline, 1 Month, 3 Months, 6 Months, 12 Months | C-terminal telopeptide is a marker of bone resorption. |
| Secondary | Percent Change From Baseline in Serum Procollagen Type 1 C-Propeptide (P1CP) at 1 Month | Baseline, 1 Month | Procollagen Type 1 N-Terminal Propeptide (P1NP) is a marker of bone formation. |
| Secondary | Convenience/Ease of Use Questionnaire (CEUQ) | baseline up to 12 months | 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. |
| Secondary | Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours | Baseline, 12 Months | 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). |
| Secondary | Change From Baseline in Urine Calcium Excretion at 6 and 12 Months | 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) | Pre-Dose, 30 minutes, 2 hours Post-Dose at Baseline and 12 Months | 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. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 12 Months | Baseline, 12 Months | 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. | percentage change in BMD | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 6 Months | Baseline, 6 Months | 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. | percentage change in BMD | LEAST_SQUARES_MEAN |
| SECONDARY | Time Course Change of BMD Response at the Lumbar Spine | Baseline to 6 Months and 12 Months | 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. | percentage change in BMD | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Procollagen Type 1 N-Terminal Propeptide (P1NP) | Baseline, 1 Month, 3 Months, 6 Months, 12 Months | All randomized participants who received at least one dose of study drug. The intent-to-treat principle was applied. | percentage change in P1NP | MEAN |
| SECONDARY | Percent Change From Baseline of C-Terminal Telopeptide (CTX) | Baseline, 1 Month, 3 Months, 6 Months, 12 Months | All randomized participants who received at least one dose of study drug. The intent-to-treat principle was applied. | percentage change in CTX | MEAN |
| SECONDARY | Percent Change From Baseline in Serum Procollagen Type 1 C-Propeptide (P1CP) at 1 Month | Baseline, 1 Month | All randomized participants who received at least one dose of study drug. The intent-to-treat principle was applied. | percentage change in P1CP | MEDIAN |
| SECONDARY | Convenience/Ease of Use Questionnaire (CEUQ) | baseline up to 12 months | 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. | participants | NUMBER |
| SECONDARY | Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours | Baseline, 12 Months | 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. | millimole/Liter (mmol/L) | MEAN |
| SECONDARY | Change From Baseline in Urine Calcium Excretion at 6 and 12 Months | Baseline, 6 Months, 12 Months | All randomized participants who received at least 1 dose of study drug and had urine calcium measurements at the indicated timepoint. | millimole/day (mmol/day) | MEAN |
| SECONDARY | Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon) | Pre-Dose, 30 minutes, 2 hours Post-Dose at Baseline and 12 Months | 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. | mmHg | MEAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group404
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 12 Months | 20 Mcg Subcutaneous Teriparatide | 7.80 | 90% Confidence Interval 6.867 to 8.730 | percentage change in BMD | |
| Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 12 Months | 30 Mcg Transdermal Teriparatide | 0.63 | 90% Confidence Interval -0.321 to 1.578 | percentage change in BMD | |
| Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 12 Months | 50 Mcg Transdermal Teriparatide | 0.32 | 90% Confidence Interval -0.657 to 1.287 | percentage change in BMD | |
| Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 12 Months | 80 Mcg Transdermal Teriparatide | 1.63 | 90% Confidence Interval 0.739 to 2.519 | percentage change in BMD | |
| Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 6 Months | 20 Mcg Subcutaneous Teriparatide | 4.74 | 90% Confidence Interval 3.953 to 5.537 | percentage change in BMD | |
| Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 6 Months | 30 Mcg Transdermal Teriparatide | 0.16 | 90% Confidence Interval -0.661 to 0.983 | percentage change in BMD | |
| Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 6 Months | 50 Mcg Transdermal Teriparatide | 0.88 | 90% Confidence Interval 0.051 to 1.705 | percentage change in BMD | |
| Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 6 Months | 80 Mcg Transdermal Teriparatide | 1.19 | 90% Confidence Interval 0.418 to 1.957 | percentage change in BMD | |
| Time Course Change of BMD Response at the Lumbar Spine | 20 Mcg Subcutaneous Teriparatide | 6 months (n=54, 52, 51, 58) | 4.72 | 90% Confidence Interval 3.927 to 5.516 | percentage change in BMD |
| Time Course Change of BMD Response at the Lumbar Spine | 30 Mcg Transdermal Teriparatide | 6 months (n=54, 52, 51, 58) | 0.19 | 90% Confidence Interval -0.630 to 1.019 | percentage change in BMD |
1 to 10 of 404Source ClinicalTrials.gov
See all 404 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 20 Mcg Subcutaneous Teriparatide | 58 | |
| Overall Study | STARTED | 30 Mcg Transdermal Teriparatide | 56 | |
| Overall Study | STARTED | 50 Mcg Transdermal Teriparatide | 55 | |
| Overall Study | STARTED | 80 Mcg Transdermal Teriparatide | 64 | |
| Overall Study | Received at Least 1 Dose of Study Drug | 20 Mcg Subcutaneous Teriparatide | 57 | |
| Overall Study | Received at Least 1 Dose of Study Drug | 30 Mcg Transdermal Teriparatide | 56 | |
| Overall Study | Received at Least 1 Dose of Study Drug | 50 Mcg Transdermal Teriparatide | 54 | |
| Overall Study | Received at Least 1 Dose of Study Drug | 80 Mcg Transdermal Teriparatide | 64 | |
| Overall Study | COMPLETED | 20 Mcg Subcutaneous Teriparatide | 52 | |
| Overall Study | COMPLETED | 30 Mcg Transdermal Teriparatide | 48 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events220
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | 20 Mcg Subcutaneous Teriparatide | 0 | 57 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | 30 Mcg Transdermal Teriparatide | 2 | 56 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | 50 Mcg Transdermal Teriparatide | 1 | 54 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | 80 Mcg Transdermal Teriparatide | 0 | 64 | 0 |
| other | Ear pain | Ear and labyrinth disorders | 20 Mcg Subcutaneous Teriparatide | 2 | 57 | 2 |
| other | Ear pain | Ear and labyrinth disorders | 30 Mcg Transdermal Teriparatide | 0 | 56 | 0 |
| other | Ear pain | Ear and labyrinth disorders | 50 Mcg Transdermal Teriparatide | 1 | 54 | 1 |
| other | Ear pain | Ear and labyrinth disorders | 80 Mcg Transdermal Teriparatide | 0 | 64 | 0 |
| other | Hypothyroidism | Endocrine disorders | 20 Mcg Subcutaneous Teriparatide | 0 | 57 | 0 |
| other | Hypothyroidism | Endocrine disorders | 30 Mcg Transdermal Teriparatide | 2 | 56 | 2 |
1 to 10 of 220Source ClinicalTrials.gov
See all 220 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 20 Mcg Subcutaneous Teriparatide | ||
| Total, all-cause mortality | 30 Mcg Transdermal Teriparatide | ||
| Total, all-cause mortality | 50 Mcg Transdermal Teriparatide | ||
| Total, all-cause mortality | 80 Mcg Transdermal Teriparatide | ||
| Total, other adverse events | 20 Mcg Subcutaneous Teriparatide | 30 | 57 |
| Total, other adverse events | 30 Mcg Transdermal Teriparatide | 33 | 56 |
| Total, other adverse events | 50 Mcg Transdermal Teriparatide | 30 | 54 |
| Total, other adverse events | 80 Mcg Transdermal Teriparatide | 39 | 64 |
| Total, serious adverse events | 20 Mcg Subcutaneous Teriparatide | 2 | 57 |
| Total, serious adverse events | 30 Mcg Transdermal Teriparatide | 2 | 56 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01011556
GET https://conductscience.org/api/trials/v1/NCT01011556/results?page=2