Trial Outcomes & Findings for One Week Parathyroid Hormone-related Protein (PTHrP) IV Dose Escalation Study (NCT NCT00580788)
NCT ID: NCT00580788
Last Updated: 2016-02-11
Results Overview
DLT was defined as achieving one major criterion or two minor criteria rated at ≥ 2 on a scale of 0-5. The major criteria were defined as symptomatic orthostatic hypotension (systolic BP fall \>30 mm/hg), tachycardia (pulse \> 120), hypertension (systolic BP \>160 mm/hg on 2 occasions), hypercalcemia (serum calcium ≥ 12 mg/dl), and hypophosphatemia (serum phosphorous \< 1.5 mg/dl). Minor criteria included symptoms such as flushing, nausea, abdominal or muscle cramps, dizziness, lightheadedness, palpitations, etc.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
14 participants
Primary outcome timeframe
12 hours after the infusion was started then q 8 hours for 7 days
Results posted on
2016-02-11
Participant Flow
24 subjects were screened and 14 were randomized in the study. Data from 2 subjects was not included in the analysis as there were not enough subjects in that group for analysis. 12 subjects were analyzed.
Participant milestones
| Measure |
Group 1
PTHrP(1-36) 2 picomoles/kg/hr
|
Group 2
PTHrP(1-36) 4 picomoles/kg/hr
|
Group 3
PTHrP (1-36) 5 pmol/kg/hr
|
Group 4
PTHrP (1-36) 6 picomoles/kg/hr
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
6
|
3
|
2
|
|
Overall Study
COMPLETED
|
3
|
6
|
3
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Group 1
PTHrP(1-36) 2 picomoles/kg/hr
|
Group 2
PTHrP(1-36) 4 picomoles/kg/hr
|
Group 3
PTHrP (1-36) 5 pmol/kg/hr
|
Group 4
PTHrP (1-36) 6 picomoles/kg/hr
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
Baseline Characteristics
One Week Parathyroid Hormone-related Protein (PTHrP) IV Dose Escalation Study
Baseline characteristics by cohort
| Measure |
Group 1
n=3 Participants
PTHrP(1-36) 2 picomoles/kg/hr for one week.
|
Group 2
n=6 Participants
PTHrP(1-36) 4 picomoles/kg/hr for one week.
|
Group 3
n=3 Participants
PTHrP(1-36) 5 picomoles/kg/hr for one week.
|
Group 4
n=2 Participants
PTHrP(1-36) 6 picomoles/kg/hr for one week.
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
6 participants
n=7 Participants
|
3 participants
n=5 Participants
|
2 participants
n=4 Participants
|
14 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 12 hours after the infusion was started then q 8 hours for 7 daysDLT was defined as achieving one major criterion or two minor criteria rated at ≥ 2 on a scale of 0-5. The major criteria were defined as symptomatic orthostatic hypotension (systolic BP fall \>30 mm/hg), tachycardia (pulse \> 120), hypertension (systolic BP \>160 mm/hg on 2 occasions), hypercalcemia (serum calcium ≥ 12 mg/dl), and hypophosphatemia (serum phosphorous \< 1.5 mg/dl). Minor criteria included symptoms such as flushing, nausea, abdominal or muscle cramps, dizziness, lightheadedness, palpitations, etc.
Outcome measures
| Measure |
Group 1
n=3 Participants
PTHrP(1-36) 2 picomoles/kg/hr for one week.
|
Group 2
n=6 Participants
PTHrP(1-36) 4 picomoles/kg/hr for one week
|
Group 3
n=3 Participants
PTHrP(1-36) 5 picomoles/kg/hr for one week
|
Group 4
n=2 Participants
PTHrP(1-36) 6 picomoles/kg/hr for one week
|
|---|---|---|---|---|
|
Dose Limiting Toxicity (DLT)
|
0 participants
|
0 participants
|
2 participants
|
2 participants
|
PRIMARY outcome
Timeframe: 12 hours after the infusion was started then q 8 hours for 7 days, Follow-up 1 week after infusion completemg/dl
Outcome measures
| Measure |
Group 1
n=3 Participants
PTHrP(1-36) 2 picomoles/kg/hr for one week.
|
Group 2
n=6 Participants
PTHrP(1-36) 4 picomoles/kg/hr for one week
|
Group 3
n=3 Participants
PTHrP(1-36) 5 picomoles/kg/hr for one week
|
Group 4
PTHrP(1-36) 6 picomoles/kg/hr for one week
|
|---|---|---|---|---|
|
Total Serum Calcium
baseline
|
9.37 mg/dl
Standard Error 0.07
|
9.58 mg/dl
Standard Error 0.12
|
9.2 mg/dl
Standard Error 0.25
|
—
|
|
Total Serum Calcium
11P DAY 1
|
9.67 mg/dl
Standard Error 0.09
|
9.80 mg/dl
Standard Error 0.16
|
9.67 mg/dl
Standard Error 0.20
|
—
|
|
Total Serum Calcium
7A DAY 2
|
9.4 mg/dl
Standard Error 0.17
|
10.05 mg/dl
Standard Error 0.19
|
10.17 mg/dl
Standard Error 0.20
|
—
|
|
Total Serum Calcium
3P DAY 2
|
9.57 mg/dl
Standard Error 0.09
|
10.28 mg/dl
Standard Error 0.14
|
10.47 mg/dl
Standard Error 0.30
|
—
|
|
Total Serum Calcium
11P DAY 2
|
9.67 mg/dl
Standard Error 0.09
|
10.32 mg/dl
Standard Error 0.14
|
10.23 mg/dl
Standard Error 0.26
|
—
|
|
Total Serum Calcium
7A DAY 3
|
9.6 mg/dl
Standard Error 0.10
|
10.40 mg/dl
Standard Error 0.18
|
10.73 mg/dl
Standard Error 0.57
|
—
|
|
Total Serum Calcium
3P DAY 3
|
9.73 mg/dl
Standard Error 0.09
|
10.42 mg/dl
Standard Error 0.14
|
10.67 mg/dl
Standard Error 0.27
|
—
|
|
Total Serum Calcium
11P DAY 3
|
9.40 mg/dl
Standard Error 0.17
|
9.73 mg/dl
Standard Error 0.10
|
9.93 mg/dl
Standard Error 0.38
|
—
|
|
Total Serum Calcium
7A DAY 4
|
9.47 mg/dl
Standard Error 0.03
|
10.00 mg/dl
Standard Error 0.24
|
10.3 mg/dl
Standard Error 0.23
|
—
|
|
Total Serum Calcium
3P DAY 4
|
9.40 mg/dl
Standard Error 0.17
|
9.92 mg/dl
Standard Error 0.21
|
10.33 mg/dl
Standard Error 0.34
|
—
|
|
Total Serum Calcium
11P DAY 4
|
9.37 mg/dl
Standard Error 0.09
|
9.48 mg/dl
Standard Error 0.11
|
10.00 mg/dl
Standard Error 0.15
|
—
|
|
Total Serum Calcium
7A DAY 5
|
9.30 mg/dl
Standard Error 0.12
|
9.62 mg/dl
Standard Error 0.12
|
10.53 mg/dl
Standard Error 0.15
|
—
|
|
Total Serum Calcium
3P DAY 5
|
9.50 mg/dl
Standard Error 0.15
|
9.83 mg/dl
Standard Error 0.20
|
10.27 mg/dl
Standard Error 0.44
|
—
|
|
Total Serum Calcium
11P DAY 5
|
9.43 mg/dl
Standard Error 0.09
|
9.45 mg/dl
Standard Error 0.13
|
9.80 mg/dl
Standard Error 0.20
|
—
|
|
Total Serum Calcium
7A DAY 6
|
9.57 mg/dl
Standard Error 0.07
|
9.83 mg/dl
Standard Error 0.20
|
10.53 mg/dl
Standard Error 0.22
|
—
|
|
Total Serum Calcium
3P DAY 6
|
9.43 mg/dl
Standard Error 0.15
|
10.08 mg/dl
Standard Error 0.12
|
10.83 mg/dl
Standard Error 0.27
|
—
|
|
Total Serum Calcium
11P DAY 6
|
9.43 mg/dl
Standard Error 0.13
|
9.67 mg/dl
Standard Error 0.21
|
10.43 mg/dl
Standard Error 0.47
|
—
|
|
Total Serum Calcium
7A DAY 7
|
9.40 mg/dl
Standard Error 0.10
|
10.13 mg/dl
Standard Error 0.28
|
10.90 mg/dl
Standard Error 0.46
|
—
|
|
Total Serum Calcium
3P DAY 7
|
9.70 mg/dl
Standard Error 0.15
|
10.22 mg/dl
Standard Error 0.32
|
10.70 mg/dl
Standard Error 0.46
|
—
|
|
Total Serum Calcium
11P DAY 7
|
9.60 mg/dl
Standard Error 0.15
|
10.27 mg/dl
Standard Error 0.28
|
10.73 mg/dl
Standard Error 0.50
|
—
|
|
Total Serum Calcium
7A DAY 8
|
9.83 mg/dl
Standard Error 0.13
|
10.67 mg/dl
Standard Error 0.40
|
11.17 mg/dl
Standard Error 0.35
|
—
|
|
Total Serum Calcium
FOLLOW-UP
|
9.33 mg/dl
Standard Error 0.07
|
9.80 mg/dl
Standard Error 0.12
|
9.17 mg/dl
Standard Error 0.24
|
—
|
PRIMARY outcome
Timeframe: 12 hours after the infusion was started then q 8 hours for 7 days, Follow-up 1 week after infusion completemg/dl
Outcome measures
| Measure |
Group 1
n=3 Participants
PTHrP(1-36) 2 picomoles/kg/hr for one week.
|
Group 2
n=6 Participants
PTHrP(1-36) 4 picomoles/kg/hr for one week
|
Group 3
n=3 Participants
PTHrP(1-36) 5 picomoles/kg/hr for one week
|
Group 4
PTHrP(1-36) 6 picomoles/kg/hr for one week
|
|---|---|---|---|---|
|
Ionized Serum Calcium
baseline
|
4.79 mg/dl
Standard Error 0.03
|
4.72 mg/dl
Standard Error 0.08
|
4.55 mg/dl
Standard Error 0.15
|
—
|
|
Ionized Serum Calcium
11P DAY 1
|
4.51 mg/dl
Standard Error 0.05
|
4.77 mg/dl
Standard Error 0.08
|
4.75 mg/dl
Standard Error 0.04
|
—
|
|
Ionized Serum Calcium
7A DAY 2
|
4.77 mg/dl
Standard Error 0.07
|
4.98 mg/dl
Standard Error 0.10
|
5.07 mg/dl
Standard Error 0.07
|
—
|
|
Ionized Serum Calcium
3P DAY 2
|
4.52 mg/dl
Standard Error 0.02
|
4.99 mg/dl
Standard Error 0.06
|
5.07 mg/dl
Standard Error 0.06
|
—
|
|
Ionized Serum Calcium
11P DAY 2
|
4.48 mg/dl
Standard Error 0.08
|
5.04 mg/dl
Standard Error 0.07
|
4.84 mg/dl
Standard Error 0.00
|
—
|
|
Ionized Serum Calcium
7A DAY 3
|
4.77 mg/dl
Standard Error 0.15
|
5.31 mg/dl
Standard Error 0.08
|
5.25 mg/dl
Standard Error 0.13
|
—
|
|
Ionized Serum Calcium
3P DAY 3
|
4.73 mg/dl
Standard Error 0.11
|
4.99 mg/dl
Standard Error 0.10
|
4.91 mg/dl
Standard Error 0.16
|
—
|
|
Ionized Serum Calcium
11P DAY 3
|
4.41 mg/dl
Standard Error 0.15
|
4.58 mg/dl
Standard Error 0.15
|
4.83 mg/dl
Standard Error 0.14
|
—
|
|
Ionized Serum Calcium
7A DAY 4
|
4.75 mg/dl
Standard Error 0.14
|
4.90 mg/dl
Standard Error 0.13
|
5.11 mg/dl
Standard Error 0.09
|
—
|
|
Ionized Serum Calcium
3P DAY 4
|
4.45 mg/dl
Standard Error 0.16
|
4.68 mg/dl
Standard Error 0.14
|
4.72 mg/dl
Standard Error 0.17
|
—
|
|
Ionized Serum Calcium
11P DAY 4
|
4.47 mg/dl
Standard Error 0.07
|
4.46 mg/dl
Standard Error 0.12
|
4.69 mg/dl
Standard Error 0.06
|
—
|
|
Ionized Serum Calcium
7A DAY 5
|
4.71 mg/dl
Standard Error 0.07
|
4.82 mg/dl
Standard Error 0.09
|
4.97 mg/dl
Standard Error 0.12
|
—
|
|
Ionized Serum Calcium
3P DAY 5
|
4.61 mg/dl
Standard Error 0.20
|
4.67 mg/dl
Standard Error 0.12
|
4.87 mg/dl
Standard Error 0.40
|
—
|
|
Ionized Serum Calcium
11P DAY 5
|
4.60 mg/dl
Standard Error 0.13
|
4.58 mg/dl
Standard Error 0.07
|
4.79 mg/dl
Standard Error 0.09
|
—
|
|
Ionized Serum Calcium
7A DAY 6
|
4.63 mg/dl
Standard Error 0.03
|
4.77 mg/dl
Standard Error 0.10
|
5.25 mg/dl
Standard Error 0.09
|
—
|
|
Ionized Serum Calcium
3P DAY 6
|
4.72 mg/dl
Standard Error 0.13
|
4.83 mg/dl
Standard Error 0.07
|
5.35 mg/dl
Standard Error 0.03
|
—
|
|
Ionized Serum Calcium
11P DAY 6
|
4.32 mg/dl
Standard Error 0.06
|
4.72 mg/dl
Standard Error 0.09
|
5.19 mg/dl
Standard Error 0.21
|
—
|
|
Ionized Serum Calcium
7A DAY 7
|
4.55 mg/dl
Standard Error 0.22
|
5.01 mg/dl
Standard Error 0.09
|
5.55 mg/dl
Standard Error 0.27
|
—
|
|
Ionized Serum Calcium
3P DAY 7
|
4.84 mg/dl
Standard Error 0.16
|
5.04 mg/dl
Standard Error 0.17
|
5.25 mg/dl
Standard Error 0.31
|
—
|
|
Ionized Serum Calcium
11P DAY 7
|
4.56 mg/dl
Standard Error 0.12
|
4.87 mg/dl
Standard Error 0.19
|
5.24 mg/dl
Standard Error 0.02
|
—
|
|
Ionized Serum Calcium
7A DAY 8
|
5.00 mg/dl
Standard Error 0.11
|
5.43 mg/dl
Standard Error 0.18
|
5.69 mg/dl
Standard Error 0.10
|
—
|
|
Ionized Serum Calcium
FOLLOW-UP
|
4.68 mg/dl
Standard Error 0.08
|
4.83 mg/dl
Standard Error 0.05
|
4.80 mg/dl
Standard Error 0.06
|
—
|
PRIMARY outcome
Timeframe: 12 hours after the infusion was started then q 8 hours for 7 days, Follow-up 1 week after infusion completemg/dl
Outcome measures
| Measure |
Group 1
n=3 Participants
PTHrP(1-36) 2 picomoles/kg/hr for one week.
|
Group 2
n=6 Participants
PTHrP(1-36) 4 picomoles/kg/hr for one week
|
Group 3
n=3 Participants
PTHrP(1-36) 5 picomoles/kg/hr for one week
|
Group 4
PTHrP(1-36) 6 picomoles/kg/hr for one week
|
|---|---|---|---|---|
|
Serum Phosphorous
baseline
|
3.55 mg/dl
Standard Error 0.15
|
3.63 mg/dl
Standard Error 0.14
|
3.55 mg/dl
Standard Error 0.45
|
—
|
|
Serum Phosphorous
11P DAY 1
|
3.87 mg/dl
Standard Error 0.26
|
3.90 mg/dl
Standard Error 0.16
|
4.03 mg/dl
Standard Error 0.12
|
—
|
|
Serum Phosphorous
7A DAY 2
|
4.07 mg/dl
Standard Error 0.15
|
4.20 mg/dl
Standard Error 0.15
|
3.63 mg/dl
Standard Error 0.44
|
—
|
|
Serum Phosphorous
3P DAY 2
|
3.63 mg/dl
Standard Error 0.33
|
3.50 mg/dl
Standard Error 0.23
|
3.70 mg/dl
Standard Error 0.20
|
—
|
|
Serum Phosphorous
11P DAY 2
|
4.13 mg/dl
Standard Error 0.29
|
3.52 mg/dl
Standard Error 0.19
|
3.63 mg/dl
Standard Error 0.19
|
—
|
|
Serum Phosphorous
7A DAY 3
|
3.90 mg/dl
Standard Error 0.26
|
3.77 mg/dl
Standard Error 0.19
|
3.43 mg/dl
Standard Error 0.39
|
—
|
|
Serum Phosphorous
3P DAY 3
|
3.53 mg/dl
Standard Error 0.24
|
3.53 mg/dl
Standard Error 0.18
|
3.60 mg/dl
Standard Error 0.23
|
—
|
|
Serum Phosphorous
11P DAY 3
|
4.03 mg/dl
Standard Error 0.26
|
3.58 mg/dl
Standard Error 0.17
|
3.70 mg/dl
Standard Error 0.15
|
—
|
|
Serum Phosphorous
7A DAY 4
|
4.07 mg/dl
Standard Error 0.22
|
3.90 mg/dl
Standard Error 0.13
|
3.30 mg/dl
Standard Error 0.40
|
—
|
|
Serum Phosphorous
3P DAY 4
|
3.90 mg/dl
Standard Error 0.10
|
3.37 mg/dl
Standard Error 0.20
|
3.33 mg/dl
Standard Error 0.32
|
—
|
|
Serum Phosphorous
11P DAY 4
|
3.67 mg/dl
Standard Error 0.28
|
3.48 mg/dl
Standard Error 0.14
|
3.63 mg/dl
Standard Error 0.27
|
—
|
|
Serum Phosphorous
7A DAY 5
|
3.87 mg/dl
Standard Error 0.19
|
4.02 mg/dl
Standard Error 0.14
|
3.20 mg/dl
Standard Error 0.30
|
—
|
|
Serum Phosphorous
3P DAY 5
|
3.57 mg/dl
Standard Error 0.29
|
3.35 mg/dl
Standard Error 0.20
|
3.10 mg/dl
Standard Error 0.21
|
—
|
|
Serum Phosphorous
11P DAY 5
|
3.93 mg/dl
Standard Error 0.23
|
3.45 mg/dl
Standard Error 0.20
|
3.87 mg/dl
Standard Error 0.32
|
—
|
|
Serum Phosphorous
7A DAY 6
|
4.00 mg/dl
Standard Error 0.06
|
4.00 mg/dl
Standard Error 0.10
|
3.63 mg/dl
Standard Error 0.35
|
—
|
|
Serum Phosphorous
3P DAY 6
|
3.67 mg/dl
Standard Error 0.03
|
3.80 mg/dl
Standard Error 0.14
|
3.73 mg/dl
Standard Error 0.19
|
—
|
|
Serum Phosphorous
11P DAY 6
|
3.93 mg/dl
Standard Error 0.18
|
3.90 mg/dl
Standard Error 0.10
|
3.93 mg/dl
Standard Error 0.09
|
—
|
|
Serum Phosphorous
7A DAY 7
|
4.30 mg/dl
Standard Error 0.10
|
4.28 mg/dl
Standard Error 0.12
|
3.73 mg/dl
Standard Error 0.38
|
—
|
|
Serum Phosphorous
3P DAY 7
|
4.07 mg/dl
Standard Error 0.09
|
3.62 mg/dl
Standard Error 0.20
|
3.50 mg/dl
Standard Error 0.20
|
—
|
|
Serum Phosphorous
11P DAY 7
|
4.20 mg/dl
Standard Error 0.26
|
3.62 mg/dl
Standard Error 0.19
|
3.60 mg/dl
Standard Error 0.30
|
—
|
|
Serum Phosphorous
7A DAY 8
|
4.43 mg/dl
Standard Error 0.15
|
4.10 mg/dl
Standard Error 0.10
|
3.40 mg/dl
Standard Error 0.23
|
—
|
|
Serum Phosphorous
FOLLOW-UP
|
3.57 mg/dl
Standard Error 0.38
|
3.48 mg/dl
Standard Error 0.26
|
3.87 mg/dl
Standard Error 0.09
|
—
|
SECONDARY outcome
Timeframe: Baseline and Daily through day 8 then at follow-up visitpg/ml
Outcome measures
| Measure |
Group 1
n=3 Participants
PTHrP(1-36) 2 picomoles/kg/hr for one week.
|
Group 2
n=6 Participants
PTHrP(1-36) 4 picomoles/kg/hr for one week
|
Group 3
n=3 Participants
PTHrP(1-36) 5 picomoles/kg/hr for one week
|
Group 4
PTHrP(1-36) 6 picomoles/kg/hr for one week
|
|---|---|---|---|---|
|
1,25 Vitamin D
baseline
|
34.13 pg/ml
Standard Error 3.03
|
45.08 pg/ml
Standard Error 4.24
|
39.0 pg/ml
Standard Error 4.09
|
—
|
|
1,25 Vitamin D
Day 2
|
38.40 pg/ml
Standard Error 5.12
|
45.88 pg/ml
Standard Error 1.53
|
39.77 pg/ml
Standard Error 2.69
|
—
|
|
1,25 Vitamin D
Day 3
|
30.13 pg/ml
Standard Error 4.57
|
36.58 pg/ml
Standard Error 4.17
|
36.73 pg/ml
Standard Error 2.75
|
—
|
|
1,25 Vitamin D
Day 4
|
32.23 pg/ml
Standard Error 2.32
|
40.38 pg/ml
Standard Error 4.18
|
35.17 pg/ml
Standard Error 2.63
|
—
|
|
1,25 Vitamin D
Day 5
|
32.27 pg/ml
Standard Error 1.80
|
46.40 pg/ml
Standard Error 6.12
|
32.07 pg/ml
Standard Error 3.79
|
—
|
|
1,25 Vitamin D
Day 6
|
42.77 pg/ml
Standard Error 4.23
|
34.90 pg/ml
Standard Error 4.91
|
35.37 pg/ml
Standard Error 2.98
|
—
|
|
1,25 Vitamin D
Day 7
|
40.53 pg/ml
Standard Error 4.38
|
37.12 pg/ml
Standard Error 3.58
|
31.17 pg/ml
Standard Error 6.84
|
—
|
|
1,25 Vitamin D
Day 8
|
32.37 pg/ml
Standard Error 3.17
|
33.43 pg/ml
Standard Error 3.13
|
30.63 pg/ml
Standard Error 4.79
|
—
|
|
1,25 Vitamin D
follow-up
|
40.10 pg/ml
Standard Error 4.01
|
45.78 pg/ml
Standard Error 4.72
|
36.33 pg/ml
Standard Error 2.11
|
—
|
SECONDARY outcome
Timeframe: 24 hoursmg/gm creatinine collected on day 7 of PTHrP infusion
Outcome measures
| Measure |
Group 1
n=3 Participants
PTHrP(1-36) 2 picomoles/kg/hr for one week.
|
Group 2
n=6 Participants
PTHrP(1-36) 4 picomoles/kg/hr for one week
|
Group 3
n=3 Participants
PTHrP(1-36) 5 picomoles/kg/hr for one week
|
Group 4
PTHrP(1-36) 6 picomoles/kg/hr for one week
|
|---|---|---|---|---|
|
24 Hour Urine Calcium
|
121.64 mg/gm creatinine
Standard Error 9.87
|
283.43 mg/gm creatinine
Standard Error 30.93
|
320.23 mg/gm creatinine
Standard Error 41.32
|
—
|
SECONDARY outcome
Timeframe: dailymg/dl calculated from daily second morning void
Outcome measures
| Measure |
Group 1
n=3 Participants
PTHrP(1-36) 2 picomoles/kg/hr for one week.
|
Group 2
n=6 Participants
PTHrP(1-36) 4 picomoles/kg/hr for one week
|
Group 3
n=3 Participants
PTHrP(1-36) 5 picomoles/kg/hr for one week
|
Group 4
PTHrP(1-36) 6 picomoles/kg/hr for one week
|
|---|---|---|---|---|
|
Tubular Maximum of Phosphorous (TmP/GFR)
Baseline
|
3.43 mg/dl
Standard Error 0.26
|
3.91 mg/dl
Standard Error 0.23
|
3.38 mg/dl
Standard Error 0.35
|
—
|
|
Tubular Maximum of Phosphorous (TmP/GFR)
Day 2
|
4.48 mg/dl
Standard Error 0.20
|
4.08 mg/dl
Standard Error 0.23
|
3.47 mg/dl
Standard Error 0.46
|
—
|
|
Tubular Maximum of Phosphorous (TmP/GFR)
Day 3
|
4.28 mg/dl
Standard Error 0.30
|
3.74 mg/dl
Standard Error 0.26
|
3.25 mg/dl
Standard Error 0.50
|
—
|
|
Tubular Maximum of Phosphorous (TmP/GFR)
Day 4
|
4.42 mg/dl
Standard Error 0.31
|
3.75 mg/dl
Standard Error 0.31
|
3.15 mg/dl
Standard Error 0.45
|
—
|
|
Tubular Maximum of Phosphorous (TmP/GFR)
Day 5
|
4.43 mg/dl
Standard Error 0.02
|
3.95 mg/dl
Standard Error 0.34
|
3.37 mg/dl
Standard Error 0.45
|
—
|
|
Tubular Maximum of Phosphorous (TmP/GFR)
Day 6
|
4.90 mg/dl
Standard Error 0.08
|
3.98 mg/dl
Standard Error 0.11
|
3.38 mg/dl
Standard Error 0.35
|
—
|
|
Tubular Maximum of Phosphorous (TmP/GFR)
Day 7
|
4.15 mg/dl
Standard Error 0.08
|
3.98 mg/dl
Standard Error 0.19
|
2.95 mg/dl
Standard Error 0.28
|
—
|
SECONDARY outcome
Timeframe: Baseline, Daily, and 1 week follow-up% change from baseline
Outcome measures
| Measure |
Group 1
n=3 Participants
PTHrP(1-36) 2 picomoles/kg/hr for one week.
|
Group 2
n=6 Participants
PTHrP(1-36) 4 picomoles/kg/hr for one week
|
Group 3
n=3 Participants
PTHrP(1-36) 5 picomoles/kg/hr for one week
|
Group 4
PTHrP(1-36) 6 picomoles/kg/hr for one week
|
|---|---|---|---|---|
|
Serum Amino-terminal Telopeptide of Collagen -1 (sNTX)
baseline
|
0.00 % change
Standard Error 0.00
|
0.00 % change
Standard Error 0.00
|
0.00 % change
Standard Error 0.00
|
—
|
|
Serum Amino-terminal Telopeptide of Collagen -1 (sNTX)
Day 2
|
32.86 % change
Standard Error 23.41
|
87.75 % change
Standard Error 18.79
|
54.21 % change
Standard Error 10.64
|
—
|
|
Serum Amino-terminal Telopeptide of Collagen -1 (sNTX)
Day 3
|
26.73 % change
Standard Error 23.19
|
91.53 % change
Standard Error 28.94
|
88.51 % change
Standard Error 19.99
|
—
|
|
Serum Amino-terminal Telopeptide of Collagen -1 (sNTX)
Day 4
|
28.32 % change
Standard Error 20.26
|
90.86 % change
Standard Error 32.25
|
89.57 % change
Standard Error 20.22
|
—
|
|
Serum Amino-terminal Telopeptide of Collagen -1 (sNTX)
Day 5
|
41.29 % change
Standard Error 20.06
|
82.36 % change
Standard Error 20.62
|
116.58 % change
Standard Error 13.85
|
—
|
|
Serum Amino-terminal Telopeptide of Collagen -1 (sNTX)
Day 6
|
11.41 % change
Standard Error 12.63
|
123.08 % change
Standard Error 28.62
|
150.82 % change
Standard Error 48.26
|
—
|
|
Serum Amino-terminal Telopeptide of Collagen -1 (sNTX)
Day 7
|
35.04 % change
Standard Error 21.44
|
161.55 % change
Standard Error 41.54
|
176.42 % change
Standard Error 50.08
|
—
|
|
Serum Amino-terminal Telopeptide of Collagen -1 (sNTX)
Day 8
|
65.77 % change
Standard Error 30.43
|
214.90 % change
Standard Error 59.26
|
108.69 % change
Standard Error 34.29
|
—
|
|
Serum Amino-terminal Telopeptide of Collagen -1 (sNTX)
follow-up
|
-14.95 % change
Standard Error 2.97
|
-3.33 % change
Standard Error 6.68
|
-9.02 % change
Standard Error 7.19
|
—
|
SECONDARY outcome
Timeframe: Baseline, Daily, and 1 week follow-up% change from baseline
Outcome measures
| Measure |
Group 1
n=3 Participants
PTHrP(1-36) 2 picomoles/kg/hr for one week.
|
Group 2
n=6 Participants
PTHrP(1-36) 4 picomoles/kg/hr for one week
|
Group 3
n=3 Participants
PTHrP(1-36) 5 picomoles/kg/hr for one week
|
Group 4
PTHrP(1-36) 6 picomoles/kg/hr for one week
|
|---|---|---|---|---|
|
Serum Carboxy-terminal Telopeptide of Collagen -1 (sCTX)
baseline
|
0.00 % change
Standard Error 0.00
|
0.00 % change
Standard Error 0.00
|
0.00 % change
Standard Error 0.00
|
—
|
|
Serum Carboxy-terminal Telopeptide of Collagen -1 (sCTX)
Day 2
|
59.78 % change
Standard Error 18.14
|
147.12 % change
Standard Error 40.72
|
105.06 % change
Standard Error 11.54
|
—
|
|
Serum Carboxy-terminal Telopeptide of Collagen -1 (sCTX)
Day 3
|
66.67 % change
Standard Error 32.24
|
180.27 % change
Standard Error 44.45
|
148.45 % change
Standard Error 36.80
|
—
|
|
Serum Carboxy-terminal Telopeptide of Collagen -1 (sCTX)
Day 4
|
71.19 % change
Standard Error 18.88
|
167.01 % change
Standard Error 47.01
|
165.16 % change
Standard Error 40.29
|
—
|
|
Serum Carboxy-terminal Telopeptide of Collagen -1 (sCTX)
Day 5
|
79.39 % change
Standard Error 23.89
|
167.27 % change
Standard Error 25.30
|
174.58 % change
Standard Error 47.26
|
—
|
|
Serum Carboxy-terminal Telopeptide of Collagen -1 (sCTX)
Day 6
|
74.09 % change
Standard Error 26.72
|
239.51 % change
Standard Error 49.42
|
230.42 % change
Standard Error 54.10
|
—
|
|
Serum Carboxy-terminal Telopeptide of Collagen -1 (sCTX)
Day 7
|
109.27 % change
Standard Error 29.39
|
283.15 % change
Standard Error 65.65
|
267.89 % change
Standard Error 104.52
|
—
|
|
Serum Carboxy-terminal Telopeptide of Collagen -1 (sCTX)
Day 8
|
110.61 % change
Standard Error 30.92
|
368.31 % change
Standard Error 93.63
|
140.58 % change
Standard Error 78.58
|
—
|
|
Serum Carboxy-terminal Telopeptide of Collagen -1 (sCTX)
follow-up
|
-35.73 % change
Standard Error 11.53
|
-8.60 % change
Standard Error 11.15
|
-41.33 % change
Standard Error 20.38
|
—
|
SECONDARY outcome
Timeframe: Baseline, Daily, and 1 week follow-up% change from baseline
Outcome measures
| Measure |
Group 1
n=3 Participants
PTHrP(1-36) 2 picomoles/kg/hr for one week.
|
Group 2
n=6 Participants
PTHrP(1-36) 4 picomoles/kg/hr for one week
|
Group 3
n=3 Participants
PTHrP(1-36) 5 picomoles/kg/hr for one week
|
Group 4
PTHrP(1-36) 6 picomoles/kg/hr for one week
|
|---|---|---|---|---|
|
Amino-terminal Peptides of Procollagen 1 (P1NP)
baseline
|
0.00 % change
Standard Error 0.00
|
0.00 % change
Standard Error 0.00
|
0.00 % change
Standard Error 0.00
|
—
|
|
Amino-terminal Peptides of Procollagen 1 (P1NP)
Day 2
|
-1.05 % change
Standard Error 4.95
|
-17.49 % change
Standard Error 5.93
|
-23.88 % change
Standard Error 6.05
|
—
|
|
Amino-terminal Peptides of Procollagen 1 (P1NP)
Day 3
|
-6.83 % change
Standard Error 2.78
|
-30.44 % change
Standard Error 7.10
|
-37.77 % change
Standard Error 6.56
|
—
|
|
Amino-terminal Peptides of Procollagen 1 (P1NP)
Day 4
|
-12.16 % change
Standard Error 0.57
|
-25.66 % change
Standard Error 9.55
|
-39.44 % change
Standard Error 4.46
|
—
|
|
Amino-terminal Peptides of Procollagen 1 (P1NP)
Day 5
|
-5.63 % change
Standard Error 2.27
|
-21.27 % change
Standard Error 8.01
|
-45.04 % change
Standard Error 3.07
|
—
|
|
Amino-terminal Peptides of Procollagen 1 (P1NP)
Day 6
|
-8.42 % change
Standard Error 5.07
|
-31.71 % change
Standard Error 7.50
|
-39.55 % change
Standard Error 1.75
|
—
|
|
Amino-terminal Peptides of Procollagen 1 (P1NP)
Day 7
|
-12.59 % change
Standard Error 6.17
|
-30.98 % change
Standard Error 8.87
|
-39.88 % change
Standard Error 2.78
|
—
|
|
Amino-terminal Peptides of Procollagen 1 (P1NP)
Day 8
|
-16.03 % change
Standard Error 5.03
|
-36.60 % change
Standard Error 9.64
|
-38.53 % change
Standard Error 3.40
|
—
|
|
Amino-terminal Peptides of Procollagen 1 (P1NP)
follow-up
|
-7.12 % change
Standard Error 2.29
|
0.60 % change
Standard Error 9.58
|
46.67 % change
Standard Error 17.34
|
—
|
SECONDARY outcome
Timeframe: Baseline, Daily, and 1 week follow-up% change from baseline
Outcome measures
| Measure |
Group 1
n=3 Participants
PTHrP(1-36) 2 picomoles/kg/hr for one week.
|
Group 2
n=6 Participants
PTHrP(1-36) 4 picomoles/kg/hr for one week
|
Group 3
n=3 Participants
PTHrP(1-36) 5 picomoles/kg/hr for one week
|
Group 4
PTHrP(1-36) 6 picomoles/kg/hr for one week
|
|---|---|---|---|---|
|
Bone Specific Alkaline Phosphatase (BSAP)
baseline
|
0.00 % change
Standard Error 0.00
|
0.00 % change
Standard Error 0.00
|
0.00 % change
Standard Error 0.00
|
—
|
|
Bone Specific Alkaline Phosphatase (BSAP)
Day 2
|
-12.53 % change
Standard Error 8.60
|
-1.17 % change
Standard Error 4.10
|
24.54 % change
Standard Error 7.01
|
—
|
|
Bone Specific Alkaline Phosphatase (BSAP)
Day 3
|
-6.35 % change
Standard Error 4.84
|
-1.44 % change
Standard Error 3.07
|
34.77 % change
Standard Error 6.53
|
—
|
|
Bone Specific Alkaline Phosphatase (BSAP)
Day 4
|
-5.82 % change
Standard Error 1.58
|
-3.79 % change
Standard Error 4.65
|
19.49 % change
Standard Error 8.23
|
—
|
|
Bone Specific Alkaline Phosphatase (BSAP)
Day 5
|
-0.33 % change
Standard Error 0.33
|
-9.64 % change
Standard Error 4.73
|
13.61 % change
Standard Error 9.76
|
—
|
|
Bone Specific Alkaline Phosphatase (BSAP)
Day 6
|
-8.16 % change
Standard Error 9.32
|
-10.88 % change
Standard Error 4.04
|
9.02 % change
Standard Error 8.94
|
—
|
|
Bone Specific Alkaline Phosphatase (BSAP)
Day 7
|
-11.91 % change
Standard Error 10.38
|
-16.78 % change
Standard Error 2.58
|
9.86 % change
Standard Error 4.01
|
—
|
|
Bone Specific Alkaline Phosphatase (BSAP)
Day 8
|
-7.80 % change
Standard Error 8.66
|
-14.01 % change
Standard Error 3.72
|
15.27 % change
Standard Error 11.63
|
—
|
|
Bone Specific Alkaline Phosphatase (BSAP)
follow-up
|
-1.25 % change
Standard Error 2.70
|
6.16 % change
Standard Error 3.81
|
18.23 % change
Standard Error 2.22
|
—
|
SECONDARY outcome
Timeframe: Baseline and Dailypg/ml
Outcome measures
| Measure |
Group 1
n=3 Participants
PTHrP(1-36) 2 picomoles/kg/hr for one week.
|
Group 2
n=6 Participants
PTHrP(1-36) 4 picomoles/kg/hr for one week
|
Group 3
n=3 Participants
PTHrP(1-36) 5 picomoles/kg/hr for one week
|
Group 4
PTHrP(1-36) 6 picomoles/kg/hr for one week
|
|---|---|---|---|---|
|
Parathyroid Hormone (1-84)
baseline
|
42.97 pg/ml
Standard Error 2.86
|
30.70 pg/ml
Standard Error 5.56
|
48.27 pg/ml
Standard Error 15.93
|
—
|
|
Parathyroid Hormone (1-84)
Day 2
|
23.47 pg/ml
Standard Error 1.48
|
7.82 pg/ml
Standard Error 1.50
|
3.60 pg/ml
Standard Error 0.50
|
—
|
|
Parathyroid Hormone (1-84)
Day 3
|
21.43 pg/ml
Standard Error 3.65
|
5.23 pg/ml
Standard Error 1.75
|
3.00 pg/ml
Standard Error 0.00
|
—
|
|
Parathyroid Hormone (1-84)
Day 4
|
26.77 pg/ml
Standard Error 3.24
|
7.88 pg/ml
Standard Error 3.21
|
3.00 pg/ml
Standard Error 0.00
|
—
|
|
Parathyroid Hormone (1-84)
Day 5
|
22.37 pg/ml
Standard Error 5.10
|
7.54 pg/ml
Standard Error 1.80
|
3.00 pg/ml
Standard Error 0.00
|
—
|
|
Parathyroid Hormone (1-84)
Day 6
|
21.13 pg/ml
Standard Error 5.88
|
6.57 pg/ml
Standard Error 2.24
|
3.00 pg/ml
Standard Error 0.00
|
—
|
|
Parathyroid Hormone (1-84)
Day 7
|
19.40 pg/ml
Standard Error 4.03
|
5.67 pg/ml
Standard Error 1.20
|
3.00 pg/ml
Standard Error 0.00
|
—
|
|
Parathyroid Hormone (1-84)
Day 8
|
12.60 pg/ml
Standard Error 3.58
|
3.00 pg/ml
Standard Error 0.00
|
3.00 pg/ml
Standard Error 0.00
|
—
|
|
Parathyroid Hormone (1-84)
follow-up
|
56.37 pg/ml
Standard Error 5.18
|
31.60 pg/ml
Standard Error 2.63
|
44.20 pg/ml
Standard Error 10.87
|
—
|
SECONDARY outcome
Timeframe: daily% calculated from daily second morning void
Outcome measures
| Measure |
Group 1
n=3 Participants
PTHrP(1-36) 2 picomoles/kg/hr for one week.
|
Group 2
n=6 Participants
PTHrP(1-36) 4 picomoles/kg/hr for one week
|
Group 3
n=3 Participants
PTHrP(1-36) 5 picomoles/kg/hr for one week
|
Group 4
PTHrP(1-36) 6 picomoles/kg/hr for one week
|
|---|---|---|---|---|
|
Fractional Excretion of Calcium
Baseline
|
1.93 % of filtered load
Standard Error 0.91
|
2.57 % of filtered load
Standard Error 0.73
|
2.38 % of filtered load
Standard Error 0.59
|
—
|
|
Fractional Excretion of Calcium
Day 2
|
1.31 % of filtered load
Standard Error 0.59
|
2.26 % of filtered load
Standard Error 0.46
|
4.11 % of filtered load
Standard Error 2.42
|
—
|
|
Fractional Excretion of Calcium
Day 3
|
1.07 % of filtered load
Standard Error 0.51
|
2.85 % of filtered load
Standard Error 0.61
|
3.27 % of filtered load
Standard Error 0.45
|
—
|
|
Fractional Excretion of Calcium
Day 4
|
1.57 % of filtered load
Standard Error 0.25
|
2.79 % of filtered load
Standard Error 0.76
|
2.14 % of filtered load
Standard Error 0.40
|
—
|
|
Fractional Excretion of Calcium
Day 5
|
3.05 % of filtered load
Standard Error 0.70
|
2.05 % of filtered load
Standard Error 0.46
|
3.12 % of filtered load
Standard Error 0.46
|
—
|
|
Fractional Excretion of Calcium
Day 6
|
3.37 % of filtered load
Standard Error 0.67
|
2.75 % of filtered load
Standard Error 0.25
|
5.42 % of filtered load
Standard Error 2.23
|
—
|
|
Fractional Excretion of Calcium
Day 7
|
2.72 % of filtered load
Standard Error 0.28
|
3.94 % of filtered load
Standard Error 0.38
|
4.13 % of filtered load
Standard Error 0.73
|
—
|
Adverse Events
Group 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 3
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Group 4
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1
n=3 participants at risk
PTHrP(1-36) 2 picomoles/kg/hr for one week.
|
Group 2
n=6 participants at risk
PTHrP(1-36) 4 picomoles/kg/hr for one week.
|
Group 3
n=3 participants at risk
PTHrP(1-36) 5 picomoles/kg/hr for one week.
|
Group 4
n=2 participants at risk
PTHrP(1-36) 6 picomoles/kg/hr for one week.
|
|---|---|---|---|---|
|
Endocrine disorders
hypercalcemia
|
0.00%
0/3 • Subjects were systematically assessed every 8 hours for adverse events
|
0.00%
0/6 • Subjects were systematically assessed every 8 hours for adverse events
|
33.3%
1/3 • Number of events 1 • Subjects were systematically assessed every 8 hours for adverse events
|
50.0%
1/2 • Number of events 1 • Subjects were systematically assessed every 8 hours for adverse events
|
|
Endocrine disorders
hypertension
|
0.00%
0/3 • Subjects were systematically assessed every 8 hours for adverse events
|
0.00%
0/6 • Subjects were systematically assessed every 8 hours for adverse events
|
0.00%
0/3 • Subjects were systematically assessed every 8 hours for adverse events
|
50.0%
1/2 • Number of events 1 • Subjects were systematically assessed every 8 hours for adverse events
|
|
Endocrine disorders
migraine
|
0.00%
0/3 • Subjects were systematically assessed every 8 hours for adverse events
|
0.00%
0/6 • Subjects were systematically assessed every 8 hours for adverse events
|
33.3%
1/3 • Number of events 1 • Subjects were systematically assessed every 8 hours for adverse events
|
0.00%
0/2 • Subjects were systematically assessed every 8 hours for adverse events
|
|
Endocrine disorders
lightheaded
|
0.00%
0/3 • Subjects were systematically assessed every 8 hours for adverse events
|
0.00%
0/6 • Subjects were systematically assessed every 8 hours for adverse events
|
33.3%
1/3 • Number of events 1 • Subjects were systematically assessed every 8 hours for adverse events
|
0.00%
0/2 • Subjects were systematically assessed every 8 hours for adverse events
|
|
Endocrine disorders
tachycardia
|
0.00%
0/3 • Subjects were systematically assessed every 8 hours for adverse events
|
0.00%
0/6 • Subjects were systematically assessed every 8 hours for adverse events
|
0.00%
0/3 • Subjects were systematically assessed every 8 hours for adverse events
|
50.0%
1/2 • Number of events 1 • Subjects were systematically assessed every 8 hours for adverse events
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place