Trial Outcomes & Findings for A Study of Teriparatide in Japanese Osteoporosis Patients (NCT NCT01430104)
NCT ID: NCT01430104
Last Updated: 2013-01-14
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
30 participants
Primary outcome timeframe
Day 28 (16 and 24 hours postdose)
Results posted on
2013-01-14
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
14-Day Lead-In Period
STARTED
|
30
|
|
14-Day Lead-In Period
COMPLETED
|
30
|
|
14-Day Lead-In Period
NOT COMPLETED
|
0
|
|
28-Day Teriparatide Treatment Period
STARTED
|
29
|
|
28-Day Teriparatide Treatment Period
Received at Least 1 Dose of Teriparatide
|
29
|
|
28-Day Teriparatide Treatment Period
COMPLETED
|
28
|
|
28-Day Teriparatide Treatment Period
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
28-Day Teriparatide Treatment Period
Adverse Event
|
1
|
Baseline Characteristics
A Study of Teriparatide in Japanese Osteoporosis Patients
Baseline characteristics by cohort
| Measure |
600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide
n=29 Participants
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.
|
|---|---|
|
Age Continuous
|
70 years
STANDARD_DEVIATION 4.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
29 participants
n=5 Participants
|
|
Number of Participants with Urine Calcium Excreted Over 0.3 Grams per Day (g/day)
Urine calcium excreted >0.3 g/day
|
0 participants
n=5 Participants
|
|
Number of Participants with Urine Calcium Excreted Over 0.3 Grams per Day (g/day)
Urine calcium excreted ≤0.3 g/day
|
29 participants
n=5 Participants
|
|
Mean Urine Calcium Excreted
|
0.12 grams per day (g/day)
STANDARD_DEVIATION 0.05 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 28 (16 and 24 hours postdose)Population: 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.
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.
Outcome measures
| Measure |
600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide
n=28 Participants
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.
|
|---|---|
|
Number of Participants With Serum Calcium Level Over 11.0 Milligrams Per Deciliter (mg/dL)
16 hours postdose
|
0 participants
0
|
|
Number of Participants With Serum Calcium Level Over 11.0 Milligrams Per Deciliter (mg/dL)
24 hours postdose
|
0 participants
|
SECONDARY outcome
Timeframe: Day 1 up to Day 28 (Teriparatide Treatment Period)Population: 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.
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.
Outcome measures
| Measure |
600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide
n=29 Participants
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.
|
|---|---|
|
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
Serum Calcium > 13.5 mg/dL
|
0 participants
|
|
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
Serum Calcium > 11.0 mg/dL
|
0 participants
|
SECONDARY outcome
Timeframe: 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)Population: 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.
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).
Outcome measures
| Measure |
600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide
n=29 Participants
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.
|
|---|---|
|
Mean Serum Calcium Levels
Baseline: 2 h postdose
|
9.11 mg/dL
Interval 9.03 to 9.19
|
|
Mean Serum Calcium Levels
Baseline: 4 h postdose
|
8.98 mg/dL
Interval 8.91 to 9.05
|
|
Mean Serum Calcium Levels
Baseline: 6 h postdose
|
8.92 mg/dL
Interval 8.86 to 8.98
|
|
Mean Serum Calcium Levels
Baseline: 16 h postdose
|
8.97 mg/dL
Interval 8.9 to 9.03
|
|
Mean Serum Calcium Levels
Baseline: 24 h postdose
|
8.74 mg/dL
Interval 8.67 to 8.81
|
|
Mean Serum Calcium Levels
Day 1: 0 h predose
|
8.74 mg/dL
Interval 8.67 to 8.81
|
|
Mean Serum Calcium Levels
Day 1: 2 h postdose
|
9.17 mg/dL
Interval 9.1 to 9.24
|
|
Mean Serum Calcium Levels
Day 1: 4 h postdose
|
9.16 mg/dL
Interval 9.09 to 9.24
|
|
Mean Serum Calcium Levels
Day 1: 6 h postdose
|
9.14 mg/dL
Interval 9.07 to 9.21
|
|
Mean Serum Calcium Levels
Day 1: 16 h postdose
|
8.85 mg/dL
Interval 8.79 to 8.91
|
|
Mean Serum Calcium Levels
Day 1: 24 h postdose
|
8.70 mg/dL
Interval 8.64 to 8.77
|
|
Mean Serum Calcium Levels
Day 7: 0 h predose (n=28)
|
9.02 mg/dL
Interval 8.95 to 9.09
|
|
Mean Serum Calcium Levels
Day 7: 2 h postdose (n=28)
|
9.41 mg/dL
Interval 9.33 to 9.48
|
|
Mean Serum Calcium Levels
Day 7: 4 h postdose (n=28)
|
9.43 mg/dL
Interval 9.35 to 9.51
|
|
Mean Serum Calcium Levels
Day 7: 6 h postdose (n=28)
|
9.36 mg/dL
Interval 9.29 to 9.42
|
|
Mean Serum Calcium Levels
Day 7: 16 h postdose (n=28)
|
9.02 mg/dL
Interval 8.96 to 9.09
|
|
Mean Serum Calcium Levels
Day 7: 24 h postdose (n=28)
|
8.82 mg/dL
Interval 8.75 to 8.89
|
|
Mean Serum Calcium Levels
Day 14: 0 h predose (n=28)
|
8.99 mg/dL
Interval 8.91 to 9.06
|
|
Mean Serum Calcium Levels
Day 14: 2 h postdose (n=28)
|
9.35 mg/dL
Interval 9.28 to 9.43
|
|
Mean Serum Calcium Levels
Day 14: 4 h postdose (n=28)
|
9.39 mg/dL
Interval 9.31 to 9.46
|
|
Mean Serum Calcium Levels
Day 14: 6 h postdose (n=28)
|
9.29 mg/dL
Interval 9.22 to 9.36
|
|
Mean Serum Calcium Levels
Day 14: 16 h postdose (n=28)
|
9.03 mg/dL
Interval 8.96 to 9.09
|
|
Mean Serum Calcium Levels
Day 14: 24 h postdose (n=28)
|
8.89 mg/dL
Interval 8.82 to 8.96
|
|
Mean Serum Calcium Levels
Day 28: 0 h predose (n=28)
|
8.98 mg/dL
Interval 8.91 to 9.05
|
|
Mean Serum Calcium Levels
Day 28: 2 h postdose (n=28)
|
9.41 mg/dL
Interval 9.33 to 9.48
|
|
Mean Serum Calcium Levels
Day 28: 4 h postdose (n=28)
|
9.42 mg/dL
Interval 9.34 to 9.5
|
|
Mean Serum Calcium Levels
Day 28: 6 h postdose (n=28)
|
9.33 mg/dL
Interval 9.26 to 9.39
|
|
Mean Serum Calcium Levels
Day 28: 16 h postdose (n=28)
|
9.04 mg/dL
Interval 8.98 to 9.11
|
|
Mean Serum Calcium Levels
Day 28: 24 h postdose (n=28)
|
8.85 mg/dL
Interval 8.78 to 8.92
|
|
Mean Serum Calcium Levels
Baseline: 0 h predose
|
9.00 mg/dL
Interval 8.92 to 9.07
|
SECONDARY outcome
Timeframe: 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)Population: 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.
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.
Outcome measures
| Measure |
600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide
n=29 Participants
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.
|
|---|---|
|
Change From Baseline in Serum Calcium
Change from Baseline at Day 1: 2 h postdose
|
0.059 mg/dL
Interval -0.006 to 0.123
|
|
Change From Baseline in Serum Calcium
Change from Baseline at Day 1: 4 h postdose
|
0.183 mg/dL
Interval 0.113 to 0.252
|
|
Change From Baseline in Serum Calcium
Change from Baseline Day 1: 0 h predose
|
-0.255 mg/dL
Interval -0.317 to -0.194
|
|
Change From Baseline in Serum Calcium
Change from Baseline at Day 1: 6 h postdose
|
0.221 mg/dL
Interval 0.163 to 0.278
|
|
Change From Baseline in Serum Calcium
Change from Baseline at Day 1: 16 h postdose
|
-0.117 mg/dL
Interval -0.172 to -0.062
|
|
Change From Baseline in Serum Calcium
Change from Baseline at Day 1: 24 h postdose
|
-0.038 mg/dL
Interval -0.092 to 0.016
|
|
Change From Baseline in Serum Calcium
Change from Baseline at Day 7: 0 h predose, n=28
|
0.018 mg/dL
Interval -0.045 to 0.08
|
|
Change From Baseline in Serum Calcium
Change from Baseline at Day 7: 2 h postdose, n=28
|
0.286 mg/dL
Interval 0.22 to 0.351
|
|
Change From Baseline in Serum Calcium
Change from Baseline at Day 7: 4 h postdose, n=28
|
0.450 mg/dL
Interval 0.379 to 0.521
|
|
Change From Baseline in Serum Calcium
Change from Baseline at Day 7: 6 h postdose, n=28
|
0.436 mg/dL
Interval 0.377 to 0.494
|
|
Change From Baseline in Serum Calcium
Change from Baseline at Day 7: 16 h postdose, n=28
|
0.061 mg/dL
Interval 0.005 to 0.117
|
|
Change From Baseline in Serum Calcium
Change from Baseline at Day 7: 24 h postdose, n=28
|
0.068 mg/dL
Interval 0.013 to 0.123
|
|
Change From Baseline in Serum Calcium
Change from Baseline at Day 14: 0 h predose, n=28
|
-0.018 mg/dL
Interval -0.08 to 0.045
|
|
Change From Baseline in Serum Calcium
Change from Baseline at Day 14: 2 h postdose, n=28
|
0.232 mg/dL
Interval 0.166 to 0.298
|
|
Change From Baseline in Serum Calcium
Change from Baseline at Day 14: 4 h postdose, n=28
|
0.404 mg/dL
Interval 0.333 to 0.474
|
|
Change From Baseline in Serum Calcium
Change from Baseline at Day 14: 6 h postdose, n=28
|
0.368 mg/dL
Interval 0.309 to 0.426
|
|
Change From Baseline in Serum Calcium
Change from Baseline at Day 14: 16 h postdose,n=28
|
0.068 mg/dL
Interval 0.012 to 0.124
|
|
Change From Baseline in Serum Calcium
Change from Baseline at Day 14: 24 h postdose,n=28
|
0.143 mg/dL
Interval 0.088 to 0.198
|
|
Change From Baseline in Serum Calcium
Change from Baseline at Day 28: 0 h predose, n=28
|
-0.021 mg/dL
Interval -0.084 to 0.041
|
|
Change From Baseline in Serum Calcium
Change from Baseline at Day 28: 2 h postdose, n=28
|
0.286 mg/dL
Interval 0.22 to 0.351
|
|
Change From Baseline in Serum Calcium
Change from Baseline at Day 28: 4 h postdose, n=28
|
0.436 mg/dL
Interval 0.365 to 0.506
|
|
Change From Baseline in Serum Calcium
Change from Baseline at Day 28: 6 h postdose, n=28
|
0.404 mg/dL
Interval 0.345 to 0.462
|
|
Change From Baseline in Serum Calcium
Change from Baseline at Day 28: 16 h postdose,n=28
|
0.082 mg/dL
Interval 0.026 to 0.138
|
|
Change From Baseline in Serum Calcium
Change from Baseline at Day 28: 24 h postdose,n=28
|
0.104 mg/dL
Interval 0.049 to 0.159
|
SECONDARY outcome
Timeframe: Day 1 up to Day 28 (28-day Teriparatide Treatment Period)Population: 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.
Urine calcium levels presented are for any day during the 28-day Teriparatide Treatment Period.
Outcome measures
| Measure |
600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide
n=29 Participants
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.
|
|---|---|
|
Number of Participants With Daily Urine Calcium Excreted Over 0.3 Grams Per Day (g/Day) at Any Time Postbaseline
|
0 participants
|
SECONDARY outcome
Timeframe: Day 1 and Day 7 and Day 14 and Day 28 (28-day Teriparatide Treatment Period)Population: 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.
Outcome measures
| Measure |
600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide
n=28 Participants
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.
|
|---|---|
|
Mean Daily Urine Calcium Excreted
Day 1
|
0.13 grams per day (g/day)
Standard Deviation 0.05
|
|
Mean Daily Urine Calcium Excreted
Day 7 (N=27)
|
0.14 grams per day (g/day)
Standard Deviation 0.05
|
|
Mean Daily Urine Calcium Excreted
Day 14 (N=27)
|
0.13 grams per day (g/day)
Standard Deviation 0.05
|
|
Mean Daily Urine Calcium Excreted
Day 28 (N=27)
|
0.13 grams per day (g/day)
Standard Deviation 0.05
|
SECONDARY outcome
Timeframe: Day 1, Day 7, Day 14, Day 28 (28-day Teriparatide Treatment Period)Population: 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.
Outcome measures
| Measure |
600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide
n=28 Participants
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.
|
|---|---|
|
Change From Baseline in Daily Urine Calcium Excreted
Change from Baseline at Day 1
|
0.01 grams per day (g/day)
Standard Deviation 0.02
|
|
Change From Baseline in Daily Urine Calcium Excreted
Change from Baseline at Day 7 (N=27)
|
0.02 grams per day (g/day)
Standard Deviation 0.03
|
|
Change From Baseline in Daily Urine Calcium Excreted
Change from Baseline at Day 14 (N=27)
|
0.01 grams per day (g/day)
Standard Deviation 0.04
|
|
Change From Baseline in Daily Urine Calcium Excreted
Change from Baseline at Day 28 (N=27)
|
0.01 grams per day (g/day)
Standard Deviation 0.04
|
SECONDARY outcome
Timeframe: 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)Population: 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.
Outcome measures
| Measure |
600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide
n=29 Participants
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.
|
|---|---|
|
Concentrations of Serum 25-Hydroxy-Vitamin D
Day 1
|
23.0 nanogram per milliliter (ng/mL)
Standard Deviation 5.4
|
|
Concentrations of Serum 25-Hydroxy-Vitamin D
Day 8 (N=28)
|
22.1 nanogram per milliliter (ng/mL)
Standard Deviation 6.2
|
|
Concentrations of Serum 25-Hydroxy-Vitamin D
Day 15 (N=28)
|
21.5 nanogram per milliliter (ng/mL)
Standard Deviation 6.6
|
|
Concentrations of Serum 25-Hydroxy-Vitamin D
Day 29 (N=28)
|
20.1 nanogram per milliliter (ng/mL)
Standard Deviation 8.0
|
|
Concentrations of Serum 25-Hydroxy-Vitamin D
Day 35 (N=28)
|
21.6 nanogram per milliliter (ng/mL)
Standard Deviation 7.2
|
SECONDARY outcome
Timeframe: 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)Population: 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.
Outcome measures
| Measure |
600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide
n=29 Participants
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.
|
|---|---|
|
Concentrations of Serum 1,25-Hydroxy-2-Vitamin D3
Day 15 (N=28)
|
108.5 picogram per milliliter (pg/mL)
Standard Deviation 40.2
|
|
Concentrations of Serum 1,25-Hydroxy-2-Vitamin D3
Day 1
|
54.0 picogram per milliliter (pg/mL)
Standard Deviation 16.9
|
|
Concentrations of Serum 1,25-Hydroxy-2-Vitamin D3
Day 8 (N=28)
|
105.3 picogram per milliliter (pg/mL)
Standard Deviation 35.2
|
|
Concentrations of Serum 1,25-Hydroxy-2-Vitamin D3
Day 29 (N=28)
|
98.1 picogram per milliliter (pg/mL)
Standard Deviation 32.0
|
|
Concentrations of Serum 1,25-Hydroxy-2-Vitamin D3
Day 35 (N=28)
|
53.9 picogram per milliliter (pg/mL)
Standard Deviation 22.3
|
Adverse Events
600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide
n=29 participants at risk
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.
|
|---|---|
|
Ear and labyrinth disorders
Vertigo positional
|
3.4%
1/29 • Number of events 1 • Adverse events data were collected during the 28-day Teriparatide Treatment Period and the 7-day Follow-up Period.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.4%
1/29 • Number of events 1 • Adverse events data were collected during the 28-day Teriparatide Treatment Period and the 7-day Follow-up Period.
|
|
Infections and infestations
Cystitis
|
3.4%
1/29 • Number of events 1 • Adverse events data were collected during the 28-day Teriparatide Treatment Period and the 7-day Follow-up Period.
|
|
Infections and infestations
Nasopharyngitis
|
3.4%
1/29 • Number of events 1 • Adverse events data were collected during the 28-day Teriparatide Treatment Period and the 7-day Follow-up Period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.4%
1/29 • Number of events 1 • Adverse events data were collected during the 28-day Teriparatide Treatment Period and the 7-day Follow-up Period.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
3.4%
1/29 • Number of events 1 • Adverse events data were collected during the 28-day Teriparatide Treatment Period and the 7-day Follow-up Period.
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.4%
1/29 • Number of events 1 • Adverse events data were collected during the 28-day Teriparatide Treatment Period and the 7-day Follow-up Period.
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60