A Study of Teriparatide in Japanese Osteoporosis Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01430104
First received: September 6, 2011
Last updated: January 7, 2013
Last verified: November 2012
Results First Received: November 27, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Osteoporosis
Interventions: Drug: Teriparatide
Drug: Aspara-CA 600 mg
Drug: Alfarol 1.0 µg

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide Aspara-CA (600 milligrams [mg]) and Alfarol (1.0 microgram [µg]) were administered orally once daily after the planned Teriparatide dose during the 14-day Lead-in Period and after the Teriparatide dose during the 28-day Treatment Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.

Participant Flow for 2 periods

Period 1:   14-Day Lead-In Period
    600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide  
STARTED     30  
COMPLETED     30  
NOT COMPLETED     0  

Period 2:   28-Day Teriparatide Treatment Period
    600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide  
STARTED     29 [1]
Received at Least 1 Dose of Teriparatide     29  
COMPLETED     28  
NOT COMPLETED     1  
Adverse Event                 1  
[1] 1 participant withdrew from the study after completing the 14-day Lead-in Period.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide Aspara-CA (600 milligrams [mg]) and Alfarol (1.0 microgram [µg]) were administered orally once daily after the planned Teriparatide dose during the 14-day Lead-in Period and after the Teriparatide dose during the 28-day Treatment Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.

Baseline Measures
    600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide  
Number of Participants  
[units: participants]
  29  
Age  
[units: years]
Mean ± Standard Deviation
  70  ± 4.4  
Gender  
[units: participants]
 
Female     29  
Male     0  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     0  
Not Hispanic or Latino     29  
Unknown or Not Reported     0  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     29  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     0  
White     0  
More than one race     0  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
Japan     29  
Number of Participants with Urine Calcium Excreted Over 0.3 Grams per Day (g/day) [1]
[units: participants]
 
Urine calcium excreted >0.3 g/day     0  
Urine calcium excreted ≤0.3 g/day     29  
Mean Urine Calcium Excreted [2]
[units: grams per day (g/day)]
Mean ± Standard Deviation
  0.12  ± 0.05  
[1] Baseline calcium measures were assessed over a 24-hour period on the last day of the 14-day Lead-in Period (Day -1), after participants had been receiving Aspara-CA and Alfarol supplements, to determine the total urine calcium excreted per day.
[2] Baseline calcium measures were assessed on the last day of the 14-day Lead-in Period (Day -1), after participants had been receiving Aspara-CA and Alfarol supplements. One participant was excluded from the analysis because the participant accidentally dropped the urine collection sample during baseline (N=28).



  Outcome Measures
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1.  Primary:   Number of Participants With Serum Calcium Level Over 11.0 Milligrams Per Deciliter (mg/dL)   [ Time Frame: Day 28 (16 and 24 hours postdose) ]

2.  Secondary:   Number of Participants With Serum Calcium Level Over 11.0 Milligrams Per Deciliter (mg/dL) and 13.5 mg/dL, Respectively at Any Time Postbaseline   [ Time Frame: Day 1 up to Day 28 (Teriparatide Treatment Period) ]

3.  Secondary:   Mean Serum Calcium Levels   [ Time Frame: Baseline (Day -1 of 14-day Lead-in Period) and Day 1 and Day 7 and Day 14 and Day 28 at 0 hours (h), 2 h, 4 h, 6 h, 16 h, and 24 h postdose (28-day Teriparatide Treatment Period) ]

4.  Secondary:   Change From Baseline in Serum Calcium   [ Time Frame: Baseline (Day -1 of the 14-day Lead-in Period), Day 1, Day 7, Day 14, Day 28 at 0 hours (h), 2 h, 4 h, 6 h, 16 h, and 24 h postdose (28-day Teriparatide Treatment Period) ]

5.  Secondary:   Number of Participants With Daily Urine Calcium Excreted Over 0.3 Grams Per Day (g/Day) at Any Time Postbaseline   [ Time Frame: Day 1 up to Day 28 (28-day Teriparatide Treatment Period) ]

6.  Secondary:   Mean Daily Urine Calcium Excreted   [ Time Frame: Day 1 and Day 7 and Day 14 and Day 28 (28-day Teriparatide Treatment Period) ]

7.  Secondary:   Change From Baseline in Daily Urine Calcium Excreted   [ Time Frame: Day 1, Day 7, Day 14, Day 28 (28-day Teriparatide Treatment Period) ]

8.  Secondary:   Concentrations of Serum 25-Hydroxy-Vitamin D   [ Time Frame: Day 1 (Predose, 28-day Teriparatide Treatment Period) and Day 8 and Day 15 and Day 29 (Follow-up Period) and Day 35 (Follow-up Period) ]

9.  Secondary:   Concentrations of Serum 1,25-Hydroxy-2-Vitamin D3   [ Time Frame: Day 1 (Predose, 28-day Teriparatide Treatment Period) and Day 8 and Day 15 and Day 29 (Follow-up Period) and Day 35 (Follow-up Period) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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.


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: NCT01430104     History of Changes
Other Study ID Numbers: 14454, B3D-JE-GHDT
Study First Received: September 6, 2011
Results First Received: November 27, 2012
Last Updated: January 7, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare