Trial Outcomes & Findings for 7 Day Continuous Parathyroid Hormone IV Infusion (NCT NCT00377312)
NCT ID: NCT00377312
Last Updated: 2016-03-22
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
11 participants
Primary outcome timeframe
12 hours after the infusion was started then q 8 hours for 7 days
Results posted on
2016-03-22
Participant Flow
Starting in October 2006, 19 Healthy caucasian males \& females between 24 - 35 yrs were screened. By November 2007 11 subjects were randomized and 10 completed the one week infusion study which was done on the Clinical and Translational Research Clinic (CTRC) at the University of Pittsburgh Medical Center (UPMC).
Candidates were non-smokers and females had negative pregnancy tests. Those on chronic medications with the exception of oral contraceptives or stable thyroid hormone replacement were excluded. Body mass index had to be less than 30, and all had normal screening labs.
Participant milestones
| Measure |
Group 1
PTH (1-34) 2 picomoles (pmols)/kg/hr
|
Group 2
PTH (1-34) 4 picomoles (pmols)/kg/hr
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
5
|
|
Overall Study
COMPLETED
|
5
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Group 1
PTH (1-34) 2 picomoles (pmols)/kg/hr
|
Group 2
PTH (1-34) 4 picomoles (pmols)/kg/hr
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
Baseline Characteristics
7 Day Continuous Parathyroid Hormone IV Infusion
Baseline characteristics by cohort
| Measure |
Parathyroid Hormone - 2 Picomoles/kg/hr.
n=6 Participants
Subjects initially entering the study receive study drug Parathyroid Hormone (1-34) in intravenous doses beginning at 2 picomoles/kg/hr. Doses will be slowly and safely escalated in groups of 3 subjects.
|
Parathyroid Hormone(1-34) - 4 Picomoles/kg/hr
n=5 Participants
Subjects received Parathyroid Hormone (1-34)intravenously at 4 picomoles/kg/hr.
|
Total
n=11 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
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 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=5 Participants
PTH(1-34) 2 picomols (pmols)/kg/hr
|
Group 2
n=5 Participants
PTH(1-34) 4 picomoles/kg/hr for one week
|
|---|---|---|
|
Participants With Dose Limiting Toxicity
|
0 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=5 Participants
PTH(1-34) 2 picomols (pmols)/kg/hr
|
Group 2
n=5 Participants
PTH(1-34) 4 picomoles/kg/hr for one week
|
|---|---|---|
|
Total Serum Calcium
Baseline
|
9.33 mg/dl
Standard Error 0.20
|
9.11 mg/dl
Standard Error 0.16
|
|
Total Serum Calcium
11P Day 1
|
9.56 mg/dl
Standard Error 0.19
|
9.78 mg/dl
Standard Error 0.21
|
|
Total Serum Calcium
7 A Day 2
|
9.74 mg/dl
Standard Error 0.15
|
10.06 mg/dl
Standard Error 0.22
|
|
Total Serum Calcium
3P Day 2
|
10.14 mg/dl
Standard Error 0.18
|
10.30 mg/dl
Standard Error 0.26
|
|
Total Serum Calcium
11P Day 2
|
9.84 mg/dl
Standard Error 0.15
|
10.38 mg/dl
Standard Error 0.37
|
|
Total Serum Calcium
7A Day 3
|
10.10 mg/dl
Standard Error 0.17
|
10.52 mg/dl
Standard Error 0.34
|
|
Total Serum Calcium
3P Day 3
|
10.32 mg/dl
Standard Error 0.26
|
10.66 mg/dl
Standard Error 0.42
|
|
Total Serum Calcium
11P Day 3
|
9.72 mg/dl
Standard Error 0.31
|
9.94 mg/dl
Standard Error 0.26
|
|
Total Serum Calcium
7A Day 4
|
10.04 mg/dl
Standard Error 0.33
|
9.88 mg/dl
Standard Error 0.17
|
|
Total Serum Calcium
3P Day 4
|
9.94 mg/dl
Standard Error 0.30
|
9.94 mg/dl
Standard Error 0.23
|
|
Total Serum Calcium
11P Day 4
|
9.54 mg/dl
Standard Error 0.29
|
9.56 mg/dl
Standard Error 0.19
|
|
Total Serum Calcium
7A Day 5
|
10.16 mg/dl
Standard Error 0.47
|
9.64 mg/dl
Standard Error 0.28
|
|
Total Serum Calcium
3P Day 5
|
10.26 mg/dl
Standard Error 0.38
|
9.72 mg/dl
Standard Error 0.31
|
|
Total Serum Calcium
11P Day 5
|
9.82 mg/dl
Standard Error 0.37
|
9.46 mg/dl
Standard Error 0.23
|
|
Total Serum Calcium
7A Day 6
|
10.18 mg/dl
Standard Error 0.33
|
9.92 mg/dl
Standard Error 0.23
|
|
Total Serum Calcium
3P Day 6
|
10.28 mg/dl
Standard Error 0.40
|
10.28 mg/dl
Standard Error 0.19
|
|
Total Serum Calcium
11P Day 6
|
9.56 mg/dl
Standard Error 0.37
|
9.60 mg/dl
Standard Error 0.31
|
|
Total Serum Calcium
7A Day 7
|
10.18 mg/dl
Standard Error 0.35
|
9.90 mg/dl
Standard Error 0.17
|
|
Total Serum Calcium
3P Day 7
|
10.02 mg/dl
Standard Error 0.39
|
9.98 mg/dl
Standard Error 0.19
|
|
Total Serum Calcium
11P Day 7
|
9.82 mg/dl
Standard Error 0.33
|
10.03 mg/dl
Standard Error 0.18
|
|
Total Serum Calcium
7A Day 8
|
10.38 mg/dl
Standard Error 0.31
|
10.50 mg/dl
Standard Error 0.22
|
|
Total Serum Calcium
FOLLOW-UP
|
9.50 mg/dl
Standard Error 0.20
|
9.50 mg/dl
Standard Error 0.12
|
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=5 Participants
PTH(1-34) 2 picomols (pmols)/kg/hr
|
Group 2
n=5 Participants
PTH(1-34) 4 picomoles/kg/hr for one week
|
|---|---|---|
|
Ionized Serum Calcium
Baseline
|
4.72 mg/dl
Standard Error 0.10
|
4.52 mg/dl
Standard Error 0.05
|
|
Ionized Serum Calcium
11P Day 1
|
4.93 mg/dl
Standard Error 0.14
|
4.54 mg/dl
Standard Error 0.18
|
|
Ionized Serum Calcium
7 A Day 2
|
5.17 mg/dl
Standard Error 0.09
|
5.04 mg/dl
Standard Error 0.11
|
|
Ionized Serum Calcium
3P Day 2
|
5.08 mg/dl
Standard Error 0.06
|
5.01 mg/dl
Standard Error 0.12
|
|
Ionized Serum Calcium
11P Day 2
|
5.01 mg/dl
Standard Error 0.15
|
4.97 mg/dl
Standard Error 0.17
|
|
Ionized Serum Calcium
7A Day 3
|
5.21 mg/dl
Standard Error 0.19
|
5.22 mg/dl
Standard Error 0.19
|
|
Ionized Serum Calcium
3P Day 3
|
5.08 mg/dl
Standard Error 0.09
|
5.11 mg/dl
Standard Error 0.20
|
|
Ionized Serum Calcium
11P Day 3
|
4.80 mg/dl
Standard Error 0.17
|
4.82 mg/dl
Standard Error 0.07
|
|
Ionized Serum Calcium
7A Day 4
|
5.10 mg/dl
Standard Error 0.09
|
4.90 mg/dl
Standard Error 0.08
|
|
Ionized Serum Calcium
3P Day 4
|
4.86 mg/dl
Standard Error 0.17
|
4.77 mg/dl
Standard Error 0.09
|
|
Ionized Serum Calcium
11P Day 4
|
4.93 mg/dl
Standard Error 0.15
|
4.70 mg/dl
Standard Error 0.06
|
|
Ionized Serum Calcium
7A Day 5
|
5.18 mg/dl
Standard Error 0.24
|
4.84 mg/dl
Standard Error 0.05
|
|
Ionized Serum Calcium
3P Day 5
|
5.03 mg/dl
Standard Error 0.18
|
4.91 mg/dl
Standard Error 0.18
|
|
Ionized Serum Calcium
11P Day 5
|
4.90 mg/dl
Standard Error 0.16
|
4.68 mg/dl
Standard Error 0.11
|
|
Ionized Serum Calcium
7A Day 6
|
5.29 mg/dl
Standard Error 0.20
|
4.95 mg/dl
Standard Error 0.13
|
|
Ionized Serum Calcium
3P Day 6
|
5.17 mg/dl
Standard Error 0.13
|
4.89 mg/dl
Standard Error 0.08
|
|
Ionized Serum Calcium
11P Day 6
|
5.02 mg/dl
Standard Error 0.18
|
4.82 mg/dl
Standard Error 0.14
|
|
Ionized Serum Calcium
7A Day 7
|
5.20 mg/dl
Standard Error 0.14
|
4.99 mg/dl
Standard Error 0.19
|
|
Ionized Serum Calcium
3P Day 7
|
4.89 mg/dl
Standard Error 0.12
|
4.88 mg/dl
Standard Error 0.18
|
|
Ionized Serum Calcium
11P Day 7
|
5.15 mg/dl
Standard Error 0.19
|
4.86 mg/dl
Standard Error 0.14
|
|
Ionized Serum Calcium
7A Day 8
|
5.34 mg/dl
Standard Error 0.18
|
5.28 mg/dl
Standard Error 0.16
|
|
Ionized Serum Calcium
FOLLOW-UP
|
4.79 mg/dl
Standard Error 0.05
|
4.70 mg/dl
Standard Error 0.12
|
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=5 Participants
PTH(1-34) 2 picomols (pmols)/kg/hr
|
Group 2
n=5 Participants
PTH(1-34) 4 picomoles/kg/hr for one week
|
|---|---|---|
|
Serum Phosphorous
Baseline
|
3.51 mg/dl
Standard Error 0.30
|
3.45 mg/dl
Standard Error 0.28
|
|
Serum Phosphorous
11P Day 1
|
4.16 mg/dl
Standard Error 0.12
|
3.78 mg/dl
Standard Error 0.19
|
|
Serum Phosphorous
7 A Day 2
|
3.78 mg/dl
Standard Error 0.15
|
3.68 mg/dl
Standard Error 0.16
|
|
Serum Phosphorous
3P Day 2
|
3.82 mg/dl
Standard Error 0.15
|
3.44 mg/dl
Standard Error 0.24
|
|
Serum Phosphorous
11P Day 2
|
3.86 mg/dl
Standard Error 0.12
|
3.78 mg/dl
Standard Error 0.11
|
|
Serum Phosphorous
7A Day 3
|
3.68 mg/dl
Standard Error 0.16
|
3.58 mg/dl
Standard Error 0.15
|
|
Serum Phosphorous
3P Day 3
|
3.68 mg/dl
Standard Error 0.18
|
3.28 mg/dl
Standard Error 0.12
|
|
Serum Phosphorous
11P Day 3
|
3.86 mg/dl
Standard Error 0.09
|
3.60 mg/dl
Standard Error 0.23
|
|
Serum Phosphorous
7A Day 4
|
3.58 mg/dl
Standard Error 0.17
|
3.64 mg/dl
Standard Error 0.18
|
|
Serum Phosphorous
3P Day 4
|
3.38 mg/dl
Standard Error 0.16
|
3.22 mg/dl
Standard Error 0.16
|
|
Serum Phosphorous
11P Day 4
|
3.76 mg/dl
Standard Error 0.07
|
3.52 mg/dl
Standard Error 0.24
|
|
Serum Phosphorous
7A Day 5
|
3.56 mg/dl
Standard Error 0.14
|
3.72 mg/dl
Standard Error 0.23
|
|
Serum Phosphorous
3P Day 5
|
3.70 mg/dl
Standard Error 0.20
|
3.22 mg/dl
Standard Error 0.24
|
|
Serum Phosphorous
11P Day 5
|
3.56 mg/dl
Standard Error 0.10
|
3.64 mg/dl
Standard Error 0.21
|
|
Serum Phosphorous
7A Day 6
|
3.86 mg/dl
Standard Error 0.12
|
3.60 mg/dl
Standard Error 0.09
|
|
Serum Phosphorous
3P Day 6
|
3.78 mg/dl
Standard Error 0.21
|
3.03 mg/dl
Standard Error 0.23
|
|
Serum Phosphorous
11P Day 6
|
3.70 mg/dl
Standard Error 0.16
|
3.63 mg/dl
Standard Error 0.09
|
|
Serum Phosphorous
7A Day 7
|
3.70 mg/dl
Standard Error 0.22
|
3.90 mg/dl
Standard Error 0.18
|
|
Serum Phosphorous
3P Day 7
|
3.12 mg/dl
Standard Error 0.17
|
3.18 mg/dl
Standard Error 0.11
|
|
Serum Phosphorous
11P Day 7
|
3.48 mg/dl
Standard Error 0.11
|
3.55 mg/dl
Standard Error 0.21
|
|
Serum Phosphorous
7A Day 8
|
3.82 mg/dl
Standard Error 0.19
|
3.80 mg/dl
Standard Error 0.09
|
|
Serum Phosphorous
FOLLOW-UP
|
4.12 mg/dl
Standard Error 0.18
|
3.64 mg/dl
Standard Error 0.28
|
SECONDARY outcome
Timeframe: baseline, daily up to Day 8 and follow-uppg/ml
Outcome measures
| Measure |
Group 1
n=5 Participants
PTH(1-34) 2 picomols (pmols)/kg/hr
|
Group 2
n=5 Participants
PTH(1-34) 4 picomoles/kg/hr for one week
|
|---|---|---|
|
1,25 Vitamin D
Day 6
|
38.00 pg/ml
Standard Error 3.13
|
35.68 pg/ml
Standard Error 3.39
|
|
1,25 Vitamin D
Day 7
|
32.18 pg/ml
Standard Error 3.41
|
28.48 pg/ml
Standard Error 2.82
|
|
1,25 Vitamin D
Day 8
|
34.78 pg/ml
Standard Error 3.57
|
33.13 pg/ml
Standard Error 3.56
|
|
1,25 Vitamin D
follow-up
|
37.06 pg/ml
Standard Error 4.46
|
40.16 pg/ml
Standard Error 4.46
|
|
1,25 Vitamin D
baseline
|
37.78 pg/ml
Standard Error 4.71
|
39.18 pg/ml
Standard Error 5.82
|
|
1,25 Vitamin D
Day 2
|
40.90 pg/ml
Standard Error 2.78
|
42.72 pg/ml
Standard Error 7.60
|
|
1,25 Vitamin D
Day 3
|
35.68 pg/ml
Standard Error 2.94
|
41.74 pg/ml
Standard Error 6.39
|
|
1,25 Vitamin D
Day 4
|
27.70 pg/ml
Standard Error 7.57
|
34.72 pg/ml
Standard Error 6.91
|
|
1,25 Vitamin D
Day 5
|
36.16 pg/ml
Standard Error 2.38
|
31.53 pg/ml
Standard Error 4.78
|
SECONDARY outcome
Timeframe: baseline, daily up to Day 8 and follow-uppg/ml
Outcome measures
| Measure |
Group 1
n=5 Participants
PTH(1-34) 2 picomols (pmols)/kg/hr
|
Group 2
n=5 Participants
PTH(1-34) 4 picomoles/kg/hr for one week
|
|---|---|---|
|
Parathyroid Hormone (1-84)
baseline
|
20.90 pg/ml
Standard Error 3.85
|
52.44 pg/ml
Standard Error 12.88
|
|
Parathyroid Hormone (1-84)
Day 2
|
3.86 pg/ml
Standard Error 0.86
|
5.30 pg/ml
Standard Error 2.11
|
|
Parathyroid Hormone (1-84)
Day 3
|
3.00 pg/ml
Standard Error 0.00
|
3.38 pg/ml
Standard Error 0.38
|
|
Parathyroid Hormone (1-84)
Day 4
|
4.12 pg/ml
Standard Error 1.12
|
5.00 pg/ml
Standard Error 2.00
|
|
Parathyroid Hormone (1-84)
Day 5
|
4.64 pg/ml
Standard Error 1.64
|
11.68 pg/ml
Standard Error 6.28
|
|
Parathyroid Hormone (1-84)
Day 6
|
3.50 pg/ml
Standard Error 0.50
|
6.34 pg/ml
Standard Error 3.73
|
|
Parathyroid Hormone (1-84)
Day 7
|
3.58 pg/ml
Standard Error 0.58
|
6.68 pg/ml
Standard Error 3.68
|
|
Parathyroid Hormone (1-84)
Day 8
|
3.09 pg/ml
Standard Error 0.09
|
3.00 pg/ml
Standard Error 0.00
|
|
Parathyroid Hormone (1-84)
follow-up
|
23.60 pg/ml
Standard Error 2.29
|
35.20 pg/ml
Standard Error 3.79
|
SECONDARY outcome
Timeframe: baseline and daily% = (S Creatinine X U Calcium)/(S Calcium X U Creatinine)
Outcome measures
| Measure |
Group 1
n=5 Participants
PTH(1-34) 2 picomols (pmols)/kg/hr
|
Group 2
n=5 Participants
PTH(1-34) 4 picomoles/kg/hr for one week
|
|---|---|---|
|
Fractional Excretion of Calcium
Day 5
|
3.90 % of excretion
Standard Error 0.69
|
2.54 % of excretion
Standard Error 0.42
|
|
Fractional Excretion of Calcium
Day 6
|
4.44 % of excretion
Standard Error 0.57
|
3.49 % of excretion
Standard Error 0.69
|
|
Fractional Excretion of Calcium
baseline
|
3.38 % of excretion
Standard Error 1.42
|
1.80 % of excretion
Standard Error 0.41
|
|
Fractional Excretion of Calcium
Day 2
|
2.83 % of excretion
Standard Error 0.27
|
2.87 % of excretion
Standard Error 0.71
|
|
Fractional Excretion of Calcium
Day 3
|
4.28 % of excretion
Standard Error 0.63
|
3.76 % of excretion
Standard Error 0.63
|
|
Fractional Excretion of Calcium
Day 4
|
2.82 % of excretion
Standard Error 0.51
|
3.87 % of excretion
Standard Error 0.89
|
|
Fractional Excretion of Calcium
Day 8
|
5.54 % of excretion
Standard Error 0.70
|
4.58 % of excretion
Standard Error 0.96
|
SECONDARY outcome
Timeframe: 24 hours period from Day 7 to Day 8mg/gm creatinine
Outcome measures
| Measure |
Group 1
n=5 Participants
PTH(1-34) 2 picomols (pmols)/kg/hr
|
Group 2
n=5 Participants
PTH(1-34) 4 picomoles/kg/hr for one week
|
|---|---|---|
|
24 Hour Urine Calcium
|
315.278845 mg/gm creatinine
Standard Error 25.0352949
|
210.24827 mg/gm creatinine
Standard Error 58.3459645
|
SECONDARY outcome
Timeframe: baseline and dailymg/dl
Outcome measures
| Measure |
Group 1
n=5 Participants
PTH(1-34) 2 picomols (pmols)/kg/hr
|
Group 2
n=5 Participants
PTH(1-34) 4 picomoles/kg/hr for one week
|
|---|---|---|
|
Tubular Maximum for Phosphorous
baseline
|
3.80 mg/dl
Standard Error 0.40
|
3.50 mg/dl
Standard Error 0.28
|
|
Tubular Maximum for Phosphorous
Day 2
|
3.28 mg/dl
Standard Error 0.16
|
3.30 mg/dl
Standard Error 0.13
|
|
Tubular Maximum for Phosphorous
Day 3
|
3.37 mg/dl
Standard Error 0.20
|
3.11 mg/dl
Standard Error 0.24
|
|
Tubular Maximum for Phosphorous
Day 4
|
3.25 mg/dl
Standard Error 0.27
|
3.66 mg/dl
Standard Error 0.37
|
|
Tubular Maximum for Phosphorous
Day 5
|
3.19 mg/dl
Standard Error 0.20
|
3.31 mg/dl
Standard Error 0.22
|
|
Tubular Maximum for Phosphorous
Day 6
|
3.45 mg/dl
Standard Error 0.16
|
3.25 mg/dl
Standard Error 0.17
|
|
Tubular Maximum for Phosphorous
Day 8
|
3.52 mg/dl
Standard Error 0.34
|
3.43 mg/dl
Standard Error 0.10
|
SECONDARY outcome
Timeframe: baseline, daily, one week follow-up% change from baseline
Outcome measures
| Measure |
Group 1
n=5 Participants
PTH(1-34) 2 picomols (pmols)/kg/hr
|
Group 2
n=5 Participants
PTH(1-34) 4 picomoles/kg/hr for one week
|
|---|---|---|
|
Serum Amino-terminal of Collagen- (sNTX)
Day 8
|
153.72039 % change from baseline
Standard Error 38.1279427
|
148.451289 % change from baseline
Standard Error 23.0512356
|
|
Serum Amino-terminal of Collagen- (sNTX)
follow-up
|
4.06445076 % change from baseline
Standard Error 8.25178671
|
1.05486408 % change from baseline
Standard Error 11.8266679
|
|
Serum Amino-terminal of Collagen- (sNTX)
baseline
|
0 % change from baseline
Standard Error 0
|
0 % change from baseline
Standard Error 0
|
|
Serum Amino-terminal of Collagen- (sNTX)
Day 2
|
61.8428952 % change from baseline
Standard Error 18.6263576
|
77.4709521 % change from baseline
Standard Error 13.5088219
|
|
Serum Amino-terminal of Collagen- (sNTX)
Day 3
|
85.7699521 % change from baseline
Standard Error 27.761763
|
85.9288044 % change from baseline
Standard Error 12.9913176
|
|
Serum Amino-terminal of Collagen- (sNTX)
Day 4
|
96.3668762 % change from baseline
Standard Error 29.0312368
|
59.9595445 % change from baseline
Standard Error 18.6508014
|
|
Serum Amino-terminal of Collagen- (sNTX)
Day 5
|
107.517148 % change from baseline
Standard Error 29.2958519
|
83.3701575 % change from baseline
Standard Error 21.9993233
|
|
Serum Amino-terminal of Collagen- (sNTX)
Day 6
|
150.594712 % change from baseline
Standard Error 38.2863053
|
120.268081 % change from baseline
Standard Error 17.8645936
|
|
Serum Amino-terminal of Collagen- (sNTX)
Day 7
|
141.193285 % change from baseline
Standard Error 28.7484727
|
109.660098 % change from baseline
Standard Error 30.4136118
|
SECONDARY outcome
Timeframe: baseline, daily, one week follow-up% change from baseline
Outcome measures
| Measure |
Group 1
n=5 Participants
PTH(1-34) 2 picomols (pmols)/kg/hr
|
Group 2
n=5 Participants
PTH(1-34) 4 picomoles/kg/hr for one week
|
|---|---|---|
|
Serum Carboxy-terminal of Collagen- 1(sCTX)
baseline
|
0 % change from baseline
Standard Error 0
|
0 % change from baseline
Standard Error 0
|
|
Serum Carboxy-terminal of Collagen- 1(sCTX)
follow-up
|
-6.78 % change from baseline
Standard Error 13.40
|
-11.82 % change from baseline
Standard Error 17.86
|
|
Serum Carboxy-terminal of Collagen- 1(sCTX)
Day 2
|
113.70 % change from baseline
Standard Error 37.63
|
104.07 % change from baseline
Standard Error 11.83
|
|
Serum Carboxy-terminal of Collagen- 1(sCTX)
Day 3
|
136.76 % change from baseline
Standard Error 45.34
|
112.11 % change from baseline
Standard Error 22.41
|
|
Serum Carboxy-terminal of Collagen- 1(sCTX)
Day 4
|
142.66 % change from baseline
Standard Error 46.55
|
70.74 % change from baseline
Standard Error 37.02
|
|
Serum Carboxy-terminal of Collagen- 1(sCTX)
Day 5
|
165.97 % change from baseline
Standard Error 55.34
|
92.13 % change from baseline
Standard Error 36.22
|
|
Serum Carboxy-terminal of Collagen- 1(sCTX)
Day 6
|
205.39 % change from baseline
Standard Error 60.11
|
141.66 % change from baseline
Standard Error 17.80
|
|
Serum Carboxy-terminal of Collagen- 1(sCTX)
Day 7
|
206.06 % change from baseline
Standard Error 60.02
|
168.77 % change from baseline
Standard Error 31.35
|
|
Serum Carboxy-terminal of Collagen- 1(sCTX)
Day 8
|
225.04 % change from baseline
Standard Error 63.07
|
244.50 % change from baseline
Standard Error 25.28
|
SECONDARY outcome
Timeframe: baseline, daily, one week follow-up% change from baseline
Outcome measures
| Measure |
Group 1
n=5 Participants
PTH(1-34) 2 picomols (pmols)/kg/hr
|
Group 2
n=5 Participants
PTH(1-34) 4 picomoles/kg/hr for one week
|
|---|---|---|
|
Amino-terminal Peptides of Procollagen- 1(P1NP)
baseline
|
0 % change from baseline
Standard Error 0
|
0 % change from baseline
Standard Error 0
|
|
Amino-terminal Peptides of Procollagen- 1(P1NP)
Day 2
|
-18.536953 % change from baseline
Standard Error 3.06129512
|
-16.118573 % change from baseline
Standard Error 9.23396676
|
|
Amino-terminal Peptides of Procollagen- 1(P1NP)
Day 3
|
-31.14427 % change from baseline
Standard Error 3.986728
|
-35.577655 % change from baseline
Standard Error 3.47737847
|
|
Amino-terminal Peptides of Procollagen- 1(P1NP)
Day 4
|
-32.942391 % change from baseline
Standard Error 1.15253446
|
-35.018736 % change from baseline
Standard Error 5.91933273
|
|
Amino-terminal Peptides of Procollagen- 1(P1NP)
Day 5
|
-31.506308 % change from baseline
Standard Error 2.94297475
|
-35.309609 % change from baseline
Standard Error 6.61031904
|
|
Amino-terminal Peptides of Procollagen- 1(P1NP)
Day 6
|
-36.35864 % change from baseline
Standard Error 5.71685066
|
-35.064188 % change from baseline
Standard Error 5.84391487
|
|
Amino-terminal Peptides of Procollagen- 1(P1NP)
Day 7
|
-40.709396 % change from baseline
Standard Error 5.7024817
|
-30.58629 % change from baseline
Standard Error 3.41615735
|
|
Amino-terminal Peptides of Procollagen- 1(P1NP)
Day 8
|
-39.046467 % change from baseline
Standard Error 4.79183284
|
-35.619862 % change from baseline
Standard Error 3.18918608
|
|
Amino-terminal Peptides of Procollagen- 1(P1NP)
follow-up
|
31.4333667 % change from baseline
Standard Error 9.87895156
|
26.3367446 % change from baseline
Standard Error 16.1801142
|
SECONDARY outcome
Timeframe: baseline, daily, one week follow-up% change from baseline
Outcome measures
| Measure |
Group 1
n=5 Participants
PTH(1-34) 2 picomols (pmols)/kg/hr
|
Group 2
n=5 Participants
PTH(1-34) 4 picomoles/kg/hr for one week
|
|---|---|---|
|
Bone Specific Alkaline Phosphatase (BSAP)
Day 5
|
-8.75 % change from baseline
Standard Error 3.39
|
-2.19 % change from baseline
Standard Error 14.10
|
|
Bone Specific Alkaline Phosphatase (BSAP)
Day 6
|
-3.42 % change from baseline
Standard Error 15.55
|
-8.89 % change from baseline
Standard Error 11.60
|
|
Bone Specific Alkaline Phosphatase (BSAP)
Day 7
|
-1.35 % change from baseline
Standard Error 12.69
|
-13.72 % change from baseline
Standard Error 12.96
|
|
Bone Specific Alkaline Phosphatase (BSAP)
Day 8
|
2.09 % change from baseline
Standard Error 11.94
|
-9.91 % change from baseline
Standard Error 16.98
|
|
Bone Specific Alkaline Phosphatase (BSAP)
baseline
|
0 % change from baseline
Standard Error 0
|
0 % change from baseline
Standard Error 0
|
|
Bone Specific Alkaline Phosphatase (BSAP)
Day 2
|
7.35 % change from baseline
Standard Error 3.22
|
7.91 % change from baseline
Standard Error 7.47
|
|
Bone Specific Alkaline Phosphatase (BSAP)
Day 3
|
-5.61 % change from baseline
Standard Error 4.67
|
9.05 % change from baseline
Standard Error 12.82
|
|
Bone Specific Alkaline Phosphatase (BSAP)
Day 4
|
4.34 % change from baseline
Standard Error 4.85
|
0.77 % change from baseline
Standard Error 9.93
|
|
Bone Specific Alkaline Phosphatase (BSAP)
follow-up
|
14.08 % change from baseline
Standard Error 9.96
|
5.51 % change from baseline
Standard Error 8.28
|
Adverse Events
Group 1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Group 2
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=6 participants at risk
PTH (1-34) 2 picomoles (pmols)/kg/hr
|
Group 2
n=5 participants at risk
PTH (1-34) 4 picomoles (pmols)/kg/hr
|
|---|---|---|
|
Endocrine disorders
hypercalcemia
|
0.00%
0/6 • 12 hours after the infusion was started then q 8 hours for 7 days, Follow-up 1 week after infusion complete
|
20.0%
1/5 • Number of events 1 • 12 hours after the infusion was started then q 8 hours for 7 days, Follow-up 1 week after infusion complete
|
|
Endocrine disorders
tachycardia
|
0.00%
0/6 • 12 hours after the infusion was started then q 8 hours for 7 days, Follow-up 1 week after infusion complete
|
20.0%
1/5 • Number of events 1 • 12 hours after the infusion was started then q 8 hours for 7 days, Follow-up 1 week after infusion complete
|
|
Endocrine disorders
IV infiltration
|
16.7%
1/6 • Number of events 1 • 12 hours after the infusion was started then q 8 hours for 7 days, Follow-up 1 week after infusion complete
|
0.00%
0/5 • 12 hours after the infusion was started then q 8 hours for 7 days, Follow-up 1 week after infusion complete
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place