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A Study of Teriparatide in Japanese Osteoporosis Patients

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ClinicalTrials.gov Identifier: NCT01430104
Recruitment Status : Completed
First Posted : September 7, 2011
Results First Posted : December 28, 2012
Last Update Posted : January 14, 2013
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Osteoporosis
Interventions Drug: Teriparatide
Drug: Aspara-CA 600 mg
Drug: Alfarol 1.0 µg
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide
Hide Arm/Group Description 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.
Period Title: 14-Day Lead-In Period
Started 30
Completed 30
Not Completed 0
Period Title: 28-Day Teriparatide Treatment Period
Started 29 [1]
Received at Least 1 Dose of Teriparatide 29
Completed 28
Not Completed 1
Reason Not Completed
Adverse Event             1
[1]
1 participant withdrew from the study after completing the 14-day Lead-in Period.
Arm/Group Title 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 29
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 29 participants
70  (4.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants
Female
29
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
29
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants
American Indian or Alaska Native
0
   0.0%
Asian
29
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
0
   0.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 29 participants
29
Number of Participants with Urine Calcium Excreted Over 0.3 Grams per Day (g/day)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 29 participants
Urine calcium excreted >0.3 g/day 0
Urine calcium excreted ≤0.3 g/day 29
[1]
Measure Description: 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.
Mean Urine Calcium Excreted   [1] 
Mean (Standard Deviation)
Unit of measure:  Grams per day (g/day)
Number Analyzed 29 participants
0.12  (0.05)
[1]
Measure Description: 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).
1.Primary Outcome
Title Number of Participants With Serum Calcium Level Over 11.0 Milligrams Per Deciliter (mg/dL)
Hide Description Total serum calcium concentration adjusted by serum albumin concentration. Corrected calcium (mg/dL) = total serum calcium concentration (mg/dL) + 4.0 - serum albumin concentration (grams per deciliter [g/dL]). Postdose refers to after Teriparatide dose.
Time Frame Day 28 (16 and 24 hours postdose)
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least 1 dose of Teriparatide and had either a 16-hour or 24-hour postdose serum calcium assessment on Day 28 were included in the analysis.
Arm/Group Title 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide
Hide Arm/Group Description:
Aspara-CA (600 milligrams [mg]) and Alfarol (1.0 microgram [µg]) were administered orally once daily after the Teriparatide dose during the 28-day Treatment Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.
Overall Number of Participants Analyzed 28
Measure Type: Number
Unit of Measure: participants
16 hours postdose 0
24 hours postdose 0
2.Secondary Outcome
Title 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
Hide Description Total serum calcium concentration adjusted by serum albumin concentration. Corrected calcium (mg/dL) = total serum calcium concentration (mg/dL) + 4.0 - serum albumin concentration (grams per deciliter [g/dL]). Serum calcium levels presented are for any time postdose on any day during the 28-day Teriparatide Treatment Period.
Time Frame Day 1 up to Day 28 (Teriparatide Treatment Period)
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least 1 dose of Teriparatide and had at least 1 postdose serum calcium assessment were included in the analysis.
Arm/Group Title 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide
Hide Arm/Group Description:
Aspara-CA (600 milligrams [mg]) and Alfarol (1.0 microgram [µg]) were administered orally once daily after the Teriparatide dose during the 28-day Treatment Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.
Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: participants
Serum Calcium > 11.0 mg/dL 0
Serum Calcium > 13.5 mg/dL 0
3.Secondary Outcome
Title Mean Serum Calcium Levels
Hide Description Daily profiles of corrected mean serum calcium levels were determined for each participant. Corrected calcium (milligram per deciliter [mg/dL]) = total serum calcium concentration (mg/dL) + 4.0 - serum albumin concentration (grams per deciliter [g/dL]). The Least Squares (LS) means were adjusted for Day, Timepoint, Day*Timepoint, and random error. At baseline, participants received only Aspara-CA and Alfarol supplements and the timepoints were based on the times before Aspara-CA and Alfarol administration (predose) and after Aspara-CA and Alfarol administration (postdose). During the 28-day Teriparatide Treatment Period, timepoints were based on before Teriparatide administration (predose) and after Teriparatide administration (postdose).
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)
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least 1 dose of Teriparatide, completed all protocol requirements, and had at least 1 postdose serum calcium assessment were included in the analysis.
Arm/Group Title 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 29
Least Squares Mean (90% Confidence Interval)
Unit of Measure: mg/dL
Baseline: 0 h predose
9.00
(8.92 to 9.07)
Baseline: 2 h postdose
9.11
(9.03 to 9.19)
Baseline: 4 h postdose
8.98
(8.91 to 9.05)
Baseline: 6 h postdose
8.92
(8.86 to 8.98)
Baseline: 16 h postdose
8.97
(8.90 to 9.03)
Baseline: 24 h postdose
8.74
(8.67 to 8.81)
Day 1: 0 h predose
8.74
(8.67 to 8.81)
Day 1: 2 h postdose
9.17
(9.10 to 9.24)
Day 1: 4 h postdose
9.16
(9.09 to 9.24)
Day 1: 6 h postdose
9.14
(9.07 to 9.21)
Day 1: 16 h postdose
8.85
(8.79 to 8.91)
Day 1: 24 h postdose
8.70
(8.64 to 8.77)
Day 7: 0 h predose (n=28)
9.02
(8.95 to 9.09)
Day 7: 2 h postdose (n=28)
9.41
(9.33 to 9.48)
Day 7: 4 h postdose (n=28)
9.43
(9.35 to 9.51)
Day 7: 6 h postdose (n=28)
9.36
(9.29 to 9.42)
Day 7: 16 h postdose (n=28)
9.02
(8.96 to 9.09)
Day 7: 24 h postdose (n=28)
8.82
(8.75 to 8.89)
Day 14: 0 h predose (n=28)
8.99
(8.91 to 9.06)
Day 14: 2 h postdose (n=28)
9.35
(9.28 to 9.43)
Day 14: 4 h postdose (n=28)
9.39
(9.31 to 9.46)
Day 14: 6 h postdose (n=28)
9.29
(9.22 to 9.36)
Day 14: 16 h postdose (n=28)
9.03
(8.96 to 9.09)
Day 14: 24 h postdose (n=28)
8.89
(8.82 to 8.96)
Day 28: 0 h predose (n=28)
8.98
(8.91 to 9.05)
Day 28: 2 h postdose (n=28)
9.41
(9.33 to 9.48)
Day 28: 4 h postdose (n=28)
9.42
(9.34 to 9.50)
Day 28: 6 h postdose (n=28)
9.33
(9.26 to 9.39)
Day 28: 16 h postdose (n=28)
9.04
(8.98 to 9.11)
Day 28: 24 h postdose (n=28)
8.85
(8.78 to 8.92)
4.Secondary Outcome
Title Change From Baseline in Serum Calcium
Hide Description Corrected calcium (milligram per deciliter [mg/dL]) = total serum calcium concentration (mg/dL) + 4.0 - serum albumin concentration (grams per deciliter [g/dL]). The Least Squares (LS) means were controlled for Day, Timepoint, Day*Timepoint, and random error. Postdose refers to after Teriparatide dose.
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)
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who complied received at least 1 dose of Teriparatide, completed all protocol requirements, and had at least 1 postdose serum calcium assessment were included in the analysis.
Arm/Group Title 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide
Hide Arm/Group Description:
Aspara-CA (600 milligrams [mg]) and Alfarol (1.0 microgram [µg]) were administered orally once daily after the Teriparatide planned dose during 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.
Overall Number of Participants Analyzed 29
Least Squares Mean (90% Confidence Interval)
Unit of Measure: mg/dL
Change from Baseline Day 1: 0 h predose
-0.255
(-0.317 to -0.194)
Change from Baseline at Day 1: 2 h postdose
0.059
(-0.006 to 0.123)
Change from Baseline at Day 1: 4 h postdose
0.183
(0.113 to 0.252)
Change from Baseline at Day 1: 6 h postdose
0.221
(0.163 to 0.278)
Change from Baseline at Day 1: 16 h postdose
-0.117
(-0.172 to -0.062)
Change from Baseline at Day 1: 24 h postdose
-0.038
(-0.092 to 0.016)
Change from Baseline at Day 7: 0 h predose, n=28
0.018
(-0.045 to 0.080)
Change from Baseline at Day 7: 2 h postdose, n=28
0.286
(0.220 to 0.351)
Change from Baseline at Day 7: 4 h postdose, n=28
0.450
(0.379 to 0.521)
Change from Baseline at Day 7: 6 h postdose, n=28
0.436
(0.377 to 0.494)
Change from Baseline at Day 7: 16 h postdose, n=28
0.061
(0.005 to 0.117)
Change from Baseline at Day 7: 24 h postdose, n=28
0.068
(0.013 to 0.123)
Change from Baseline at Day 14: 0 h predose, n=28
-0.018
(-0.080 to 0.045)
Change from Baseline at Day 14: 2 h postdose, n=28
0.232
(0.166 to 0.298)
Change from Baseline at Day 14: 4 h postdose, n=28
0.404
(0.333 to 0.474)
Change from Baseline at Day 14: 6 h postdose, n=28
0.368
(0.309 to 0.426)
Change from Baseline at Day 14: 16 h postdose,n=28
0.068
(0.012 to 0.124)
Change from Baseline at Day 14: 24 h postdose,n=28
0.143
(0.088 to 0.198)
Change from Baseline at Day 28: 0 h predose, n=28
-0.021
(-0.084 to 0.041)
Change from Baseline at Day 28: 2 h postdose, n=28
0.286
(0.220 to 0.351)
Change from Baseline at Day 28: 4 h postdose, n=28
0.436
(0.365 to 0.506)
Change from Baseline at Day 28: 6 h postdose, n=28
0.404
(0.345 to 0.462)
Change from Baseline at Day 28: 16 h postdose,n=28
0.082
(0.026 to 0.138)
Change from Baseline at Day 28: 24 h postdose,n=28
0.104
(0.049 to 0.159)
5.Secondary Outcome
Title Number of Participants With Daily Urine Calcium Excreted Over 0.3 Grams Per Day (g/Day) at Any Time Postbaseline
Hide Description Urine calcium levels presented are for any day during the 28-day Teriparatide Treatment Period.
Time Frame Day 1 up to Day 28 (28-day Teriparatide Treatment Period)
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least 1 dose of Teriparatide and had at least 1 postdose urine calcium assessment were included in the analysis.
Arm/Group Title 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide
Hide Arm/Group Description:
Aspara-CA (600 milligrams [mg]) and Alfarol (1.0 microgram [µg]) were administered orally once daily after the Teriparatide dose during the 28-day Treatment Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.
Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: participants
0
6.Secondary Outcome
Title Mean Daily Urine Calcium Excreted
Hide Description [Not Specified]
Time Frame Day 1 and Day 7 and Day 14 and Day 28 (28-day Teriparatide Treatment Period)
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least 1 dose of Teriparatide and had at least 1 postdose urine calcium assessment were included in the analysis.
Arm/Group Title 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide
Hide Arm/Group Description:
Aspara-CA (600 milligrams [mg]) and Alfarol (1.0 microgram [µg]) were administered orally once daily after the Teriparatide dose during the 28-day Treatment Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.
Overall Number of Participants Analyzed 28
Mean (Standard Deviation)
Unit of Measure: grams per day (g/day)
Day 1 0.13  (0.05)
Day 7 (N=27) 0.14  (0.05)
Day 14 (N=27) 0.13  (0.05)
Day 28 (N=27) 0.13  (0.05)
7.Secondary Outcome
Title Change From Baseline in Daily Urine Calcium Excreted
Hide Description [Not Specified]
Time Frame Day 1, Day 7, Day 14, Day 28 (28-day Teriparatide Treatment Period)
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least 1 dose of Teriparatide, had a baseline urine calcium assessment, and at least 1 postdose urine calcium assessment were included in the analysis.
Arm/Group Title 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide
Hide Arm/Group Description:
Aspara-CA (600 milligrams [mg]) and Alfarol (1.0 microgram [µg]) were administered orally once daily after the Teriparatide dose during the 28-day Treatment Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.
Overall Number of Participants Analyzed 28
Mean (Standard Deviation)
Unit of Measure: grams per day (g/day)
Change from Baseline at Day 1 0.01  (0.02)
Change from Baseline at Day 7 (N=27) 0.02  (0.03)
Change from Baseline at Day 14 (N=27) 0.01  (0.04)
Change from Baseline at Day 28 (N=27) 0.01  (0.04)
8.Secondary Outcome
Title Concentrations of Serum 25-Hydroxy-Vitamin D
Hide Description [Not Specified]
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)
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least 1 dose of Teriparatide and had at least 1 postdose serum 25-Hydroxy-Vitamin D assessment were included in the analysis.
Arm/Group Title 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide
Hide Arm/Group Description:
Aspara-CA (600 milligrams [mg]) and Alfarol (1.0 microgram [µg]) were administered orally once daily after the Teriparatide dose during the 28-day Treatment Period and after the planned Teriparatide dose during the 7-day Follow-up Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.
Overall Number of Participants Analyzed 29
Mean (Standard Deviation)
Unit of Measure: nanogram per milliliter (ng/mL)
Day 1 23.0  (5.4)
Day 8 (N=28) 22.1  (6.2)
Day 15 (N=28) 21.5  (6.6)
Day 29 (N=28) 20.1  (8.0)
Day 35 (N=28) 21.6  (7.2)
9.Secondary Outcome
Title Concentrations of Serum 1,25-Hydroxy-2-Vitamin D3
Hide Description [Not Specified]
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)
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least 1 dose of Teriparatide and had at least 1 postdose serum 1,25-Hydroxy-Vitamin D3 assessment were included in the analysis.
Arm/Group Title 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide
Hide Arm/Group Description:
Aspara-CA (600 milligrams [mg]) and Alfarol (1.0 microgram [µg]) were administered orally once daily after the Teriparatide dose during the 28-day Treatment Period and after the planned Teriparatide dose during the 7-day Follow-up Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.
Overall Number of Participants Analyzed 29
Mean (Standard Deviation)
Unit of Measure: picogram per milliliter (pg/mL)
Day 1 54.0  (16.9)
Day 8 (N=28) 105.3  (35.2)
Day 15 (N=28) 108.5  (40.2)
Day 29 (N=28) 98.1  (32.0)
Day 35 (N=28) 53.9  (22.3)
Time Frame Adverse events data were collected during the 28-day Teriparatide Treatment Period and the 7-day Follow-up Period.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide
Hide Arm/Group Description Aspara-CA (600 milligrams [mg]) and Alfarol (1.0 microgram [µg]) were administered orally once daily after the Teriparatide dose during the 28-day Treatment Period and the 7-day Follow-up Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.
All-Cause Mortality
600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide
Affected / at Risk (%) # Events
Total   0/29 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide
Affected / at Risk (%) # Events
Total   5/29 (17.24%)    
Ear and labyrinth disorders   
Vertigo positional  1  1/29 (3.45%)  1
Gastrointestinal disorders   
Diarrhoea  1  1/29 (3.45%)  1
Infections and infestations   
Cystitis  1  1/29 (3.45%)  1
Nasopharyngitis  1  1/29 (3.45%)  1
Musculoskeletal and connective tissue disorders   
Back pain  1  1/29 (3.45%)  1
Respiratory, thoracic and mediastinal disorders   
Rhinorrhoea  1  1/29 (3.45%)  1
Skin and subcutaneous tissue disorders   
Rash  1  1/29 (3.45%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01430104    
Other Study ID Numbers: 14454
B3D-JE-GHDT ( Other Identifier: Eli Lilly and Company )
First Submitted: September 6, 2011
First Posted: September 7, 2011
Results First Submitted: November 27, 2012
Results First Posted: December 28, 2012
Last Update Posted: January 14, 2013