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A Study for the Transdermal Application of Teriparatide

This study has been completed.
Sponsor:
Collaborator:
TransPharma Medical
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01011556
First received: November 9, 2009
Last updated: September 21, 2012
Last verified: September 2012
History of Changes
Results First Received: September 21, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Osteoporosis
Interventions: Drug: Subcutaneous Teriparatide
Drug: Transdermal Teriparatide

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
20 Mcg Subcutaneous Teriparatide Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.
30 Mcg Transdermal Teriparatide Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
50 Mcg Transdermal Teriparatide Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
80 Mcg Transdermal Teriparatide Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.

Participant Flow:   Overall Study
    20 Mcg Subcutaneous Teriparatide     30 Mcg Transdermal Teriparatide     50 Mcg Transdermal Teriparatide     80 Mcg Transdermal Teriparatide  
STARTED     58     56     55     64  
Received at Least 1 Dose of Study Drug     57     56     54     64  
COMPLETED     52     48     45     51  
NOT COMPLETED     6     8     10     13  
Adverse Event                 1                 3                 2                 1  
Lost to Follow-up                 1                 0                 0                 0  
Physician Decision                 1                 0                 0                 1  
Protocol Violation                 0                 1                 0                 0  
Withdrawal by Subject                 1                 2                 4                 4  
Sponsor decision                 0                 1                 1                 2  
Inclusion/exclusion criteria not met                 2                 1                 3                 5  



  Baseline Characteristics
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Reporting Groups
  Description
20 Mcg Subcutaneous Teriparatide Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.
30 Mcg Transdermal Teriparatide Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
50 Mcg Transdermal Teriparatide Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
80 Mcg Transdermal Teriparatide Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
Total Total of all reporting groups

Baseline Measures
    20 Mcg Subcutaneous Teriparatide     30 Mcg Transdermal Teriparatide     50 Mcg Transdermal Teriparatide     80 Mcg Transdermal Teriparatide     Total  
Number of Participants  
[units: participants]
 		  57     56     54     64     231  
Age  
[units: years]
Mean ± Standard Deviation 		  63.9  ± 7.2     65.0  ± 8.3     67.6  ± 8.4     65.1  ± 7.2     65.4  ± 7.8  
Gender  
[units: participants]
 		         
Female     57     56     54     64     231  
Male     0     0     0     0     0  
Race/Ethnicity, Customized  
[units: participants]
 		         
Hispanic or Latino     14     15     14     17     60  
Latin American     0     2     1     0     3  
Mexican     7     6     5     6     24  
Not Hispanic or Latino     33     32     32     40     137  
South American     1     1     1     0     3  
Spaniard     2     0     1     1     4  
Region of Enrollment  
[units: participants]
 		         
Estonia     4     1     6     4     15  
Hungary     21     25     23     25     94  
Mexico     7     6     5     6     24  
Argentina     17     17     16     18     68  
Romania     8     7     4     11     30  



  Outcome Measures
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1.  Primary:   Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 12 Months   [ Time Frame: Baseline, 12 Months ]
  Show Outcome Measure 1

2.  Secondary:   Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 6 Months   [ Time Frame: Baseline, 6 Months ]
  Show Outcome Measure 2

3.  Secondary:   Time Course Change of BMD Response at the Lumbar Spine   [ Time Frame: Baseline to 6 Months and 12 Months ]
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4.  Secondary:   Percent Change From Baseline in Procollagen Type 1 N-Terminal Propeptide (P1NP)   [ Time Frame: Baseline, 1 Month, 3 Months, 6 Months, 12 Months ]
  Show Outcome Measure 4

5.  Secondary:   Percent Change From Baseline of C-Terminal Telopeptide (CTX)   [ Time Frame: Baseline, 1 Month, 3 Months, 6 Months, 12 Months ]
  Show Outcome Measure 5

6.  Secondary:   Percent Change From Baseline in Serum Procollagen Type 1 C-Propeptide (P1CP) at 1 Month   [ Time Frame: Baseline, 1 Month ]
  Show Outcome Measure 6

7.  Secondary:   Convenience/Ease of Use Questionnaire (CEUQ)   [ Time Frame: baseline up to 12 months ]
  Show Outcome Measure 7

8.  Secondary:   Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours   [ Time Frame: Baseline, 12 Months ]
  Show Outcome Measure 8

9.  Secondary:   Change From Baseline in Urine Calcium Excretion at 6 and 12 Months   [ Time Frame: Baseline, 6 Months, 12 Months ]
  Show Outcome Measure 9

10.  Secondary:   Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon)   [ Time Frame: Pre-Dose, 30 minutes, 2 hours Post-Dose at Baseline and 12 Months ]
  Show Outcome Measure 10

11.  Secondary:   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 ]
  Show Outcome Measure 11

12.  Secondary:   Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels   [ Time Frame: Baseline and 1, 3, 12, and 13 Months (mon) ]
  Show Outcome Measure 12

13.  Secondary:   Pharmacokinetics Parameters: Area Under the Curve (AUC)   [ Time Frame: Baseline, 1 Month, 3 Months, and 12 Months ]
  Show Outcome Measure 13

14.  Secondary:   Pharmacokinetics Parameters: Maximal Concentration (Cmax)   [ Time Frame: Baseline, 1 Month, 3 Months, 12 Months ]
  Show Outcome Measure 14

15.  Secondary:   DRAIZE Edema Assessment at Baseline Through 13 Month Follow-up   [ Time Frame: 13 Month follow-up ]
  Show Outcome Measure 15

16.  Secondary:   DRAIZE Erythema Assessment at Baseline Through 13 Month Follow-up   [ Time Frame: 13 Month follow-up ]
  Show Outcome Measure 16


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979


No publications provided


Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01011556     History of Changes
Other Study ID Numbers: 12641, I2Y-MC-GHFA(c)
Study First Received: November 9, 2009
Results First Received: September 21, 2012
Last Updated: September 21, 2012
Health Authority: Hungary: National Institute of Pharmacy
Estonia: The State Agency of Medicine
Romania: National Medicines Agency
Mexico: Federal Commission for Sanitary Risks Protection
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica