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7 Day Continuous Parathyroid Hormone IV Infusion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00377312
Recruitment Status : Completed
First Posted : September 18, 2006
Results First Posted : March 22, 2016
Last Update Posted : March 22, 2016
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Mara Horwitz, University of Pittsburgh

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: Single (Participant)
Conditions Osteoporosis
Bone Diseases, Endocrine
Hyperparathyroidism
Intervention Drug: Parathyroid Hormone (1-34)
Enrollment 11
Recruitment Details 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).
Pre-assignment Details 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.
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description PTH (1-34) 2 picomoles (pmols)/kg/hr PTH (1-34) 4 picomoles (pmols)/kg/hr
Period Title: Overall Study
Started 6 5
Completed 5 4
Not Completed 1 1
Reason Not Completed
Adverse Event             1             1
Arm/Group Title Parathyroid Hormone - 2 Picomoles/kg/hr. Parathyroid Hormone(1-34) - 4 Picomoles/kg/hr Total
Hide Arm/Group Description 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. Subjects received Parathyroid Hormone (1-34)intravenously at 4 picomoles/kg/hr. Total of all reporting groups
Overall Number of Baseline Participants 6 5 11
Hide Baseline Analysis Population Description
Eleven subjects received parathyroid hormone (1-34) infusions intravenously for one week.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 5 participants 11 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
6
 100.0%
5
 100.0%
11
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 5 participants 11 participants
Female
4
  66.7%
1
  20.0%
5
  45.5%
Male
2
  33.3%
4
  80.0%
6
  54.5%
1.Primary Outcome
Title Participants With Dose Limiting Toxicity
Hide Description 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.
Time Frame 12 hours after the infusion was started then q 8 hours for 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description:
PTH(1-34) 2 picomols (pmols)/kg/hr
PTH(1-34) 4 picomoles/kg/hr for one week
Overall Number of Participants Analyzed 5 5
Measure Type: Number
Unit of Measure: participants
0 2
2.Primary Outcome
Title Total Serum Calcium
Hide Description mg/dl
Time Frame 12 hours after the infusion was started then q 8 hours for 7 days, Follow-up 1 week after infusion complete
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description:
PTH(1-34) 2 picomols (pmols)/kg/hr
PTH(1-34) 4 picomoles/kg/hr for one week
Overall Number of Participants Analyzed 5 5
Mean (Standard Error)
Unit of Measure: mg/dl
Baseline 9.33  (0.20) 9.11  (0.16)
11P Day 1 9.56  (0.19) 9.78  (0.21)
7 A Day 2 9.74  (0.15) 10.06  (0.22)
3P Day 2 10.14  (0.18) 10.30  (0.26)
11P Day 2 9.84  (0.15) 10.38  (0.37)
7A Day 3 10.10  (0.17) 10.52  (0.34)
3P Day 3 10.32  (0.26) 10.66  (0.42)
11P Day 3 9.72  (0.31) 9.94  (0.26)
7A Day 4 10.04  (0.33) 9.88  (0.17)
3P Day 4 9.94  (0.30) 9.94  (0.23)
11P Day 4 9.54  (0.29) 9.56  (0.19)
7A Day 5 10.16  (0.47) 9.64  (0.28)
3P Day 5 10.26  (0.38) 9.72  (0.31)
11P Day 5 9.82  (0.37) 9.46  (0.23)
7A Day 6 10.18  (0.33) 9.92  (0.23)
3P Day 6 10.28  (0.40) 10.28  (0.19)
11P Day 6 9.56  (0.37) 9.60  (0.31)
7A Day 7 10.18  (0.35) 9.90  (0.17)
3P Day 7 10.02  (0.39) 9.98  (0.19)
11P Day 7 9.82  (0.33) 10.03  (0.18)
7A Day 8 10.38  (0.31) 10.50  (0.22)
FOLLOW-UP 9.50  (0.20) 9.50  (0.12)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.
Statistical Test of Hypothesis P-Value <.0001
Comments The reported p-value corresponds to the increase over time for the PTH 2 pmol group.
Method Mixed Models Analysis
Comments The level of statistical significance was set at .05 (two-tailed)
3.Primary Outcome
Title Ionized Serum Calcium
Hide Description mg/dl
Time Frame 12 hours after the infusion was started then q 8 hours for 7 days, Follow-up 1 week after infusion complete
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description:
PTH(1-34) 2 picomols (pmols)/kg/hr
PTH(1-34) 4 picomoles/kg/hr for one week
Overall Number of Participants Analyzed 5 5
Mean (Standard Error)
Unit of Measure: mg/dl
Baseline 4.72  (0.10) 4.52  (0.05)
11P Day 1 4.93  (0.14) 4.54  (0.18)
7 A Day 2 5.17  (0.09) 5.04  (0.11)
3P Day 2 5.08  (0.06) 5.01  (0.12)
11P Day 2 5.01  (0.15) 4.97  (0.17)
7A Day 3 5.21  (0.19) 5.22  (0.19)
3P Day 3 5.08  (0.09) 5.11  (0.20)
11P Day 3 4.80  (0.17) 4.82  (0.07)
7A Day 4 5.10  (0.09) 4.90  (0.08)
3P Day 4 4.86  (0.17) 4.77  (0.09)
11P Day 4 4.93  (0.15) 4.70  (0.06)
7A Day 5 5.18  (0.24) 4.84  (0.05)
3P Day 5 5.03  (0.18) 4.91  (0.18)
11P Day 5 4.90  (0.16) 4.68  (0.11)
7A Day 6 5.29  (0.20) 4.95  (0.13)
3P Day 6 5.17  (0.13) 4.89  (0.08)
11P Day 6 5.02  (0.18) 4.82  (0.14)
7A Day 7 5.20  (0.14) 4.99  (0.19)
3P Day 7 4.89  (0.12) 4.88  (0.18)
11P Day 7 5.15  (0.19) 4.86  (0.14)
7A Day 8 5.34  (0.18) 5.28  (0.16)
FOLLOW-UP 4.79  (0.05) 4.70  (0.12)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.
Statistical Test of Hypothesis P-Value <.0001
Comments The reported p-value corresponds to the increase over time for the PTH 2 pmol group.
Method Mixed Models Analysis
Comments The level of statistical significance was set at .05 (two-tailed)
4.Primary Outcome
Title Serum Phosphorous
Hide Description mg/dl
Time Frame 12 hours after the infusion was started then q 8 hours for 7 days, Follow-up 1 week after infusion complete
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description:
PTH(1-34) 2 picomols (pmols)/kg/hr
PTH(1-34) 4 picomoles/kg/hr for one week
Overall Number of Participants Analyzed 5 5
Mean (Standard Error)
Unit of Measure: mg/dl
Baseline 3.51  (0.30) 3.45  (0.28)
11P Day 1 4.16  (0.12) 3.78  (0.19)
7 A Day 2 3.78  (0.15) 3.68  (0.16)
3P Day 2 3.82  (0.15) 3.44  (0.24)
11P Day 2 3.86  (0.12) 3.78  (0.11)
7A Day 3 3.68  (0.16) 3.58  (0.15)
3P Day 3 3.68  (0.18) 3.28  (0.12)
11P Day 3 3.86  (0.09) 3.60  (0.23)
7A Day 4 3.58  (0.17) 3.64  (0.18)
3P Day 4 3.38  (0.16) 3.22  (0.16)
11P Day 4 3.76  (0.07) 3.52  (0.24)
7A Day 5 3.56  (0.14) 3.72  (0.23)
3P Day 5 3.70  (0.20) 3.22  (0.24)
11P Day 5 3.56  (0.10) 3.64  (0.21)
7A Day 6 3.86  (0.12) 3.60  (0.09)
3P Day 6 3.78  (0.21) 3.03  (0.23)
11P Day 6 3.70  (0.16) 3.63  (0.09)
7A Day 7 3.70  (0.22) 3.90  (0.18)
3P Day 7 3.12  (0.17) 3.18  (0.11)
11P Day 7 3.48  (0.11) 3.55  (0.21)
7A Day 8 3.82  (0.19) 3.80  (0.09)
FOLLOW-UP 4.12  (0.18) 3.64  (0.28)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1, Group 2
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.
Statistical Test of Hypothesis P-Value >0.05
Comments The reported p-value corresponds to change over time for the PTH 2 and PTH 4 pmol groups
Method Mixed Models Analysis
Comments The level of statistical significance was set at .05 (two-tailed)
5.Secondary Outcome
Title 1,25 Vitamin D
Hide Description pg/ml
Time Frame baseline, daily up to Day 8 and follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description:
PTH(1-34) 2 picomols (pmols)/kg/hr
PTH(1-34) 4 picomoles/kg/hr for one week
Overall Number of Participants Analyzed 5 5
Mean (Standard Error)
Unit of Measure: pg/ml
baseline 37.78  (4.71) 39.18  (5.82)
Day 2 40.90  (2.78) 42.72  (7.60)
Day 3 35.68  (2.94) 41.74  (6.39)
Day 4 27.70  (7.57) 34.72  (6.91)
Day 5 36.16  (2.38) 31.53  (4.78)
Day 6 38.00  (3.13) 35.68  (3.39)
Day 7 32.18  (3.41) 28.48  (2.82)
Day 8 34.78  (3.57) 33.13  (3.56)
follow-up 37.06  (4.46) 40.16  (4.46)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1, Group 2
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.
Statistical Test of Hypothesis P-Value .01
Comments The reported p-value corresponds to change over time for the PTH 2 and PTH 4 pmol groups
Method Mixed Models Analysis
Comments The level of statistical significance was set at .05 (two-tailed)
6.Secondary Outcome
Title Parathyroid Hormone (1-84)
Hide Description pg/ml
Time Frame baseline, daily up to Day 8 and follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description:
PTH(1-34) 2 picomols (pmols)/kg/hr
PTH(1-34) 4 picomoles/kg/hr for one week
Overall Number of Participants Analyzed 5 5
Mean (Standard Error)
Unit of Measure: pg/ml
baseline 20.90  (3.85) 52.44  (12.88)
Day 2 3.86  (0.86) 5.30  (2.11)
Day 3 3.00  (0.00) 3.38  (0.38)
Day 4 4.12  (1.12) 5.00  (2.00)
Day 5 4.64  (1.64) 11.68  (6.28)
Day 6 3.50  (0.50) 6.34  (3.73)
Day 7 3.58  (0.58) 6.68  (3.68)
Day 8 3.09  (0.09) 3.00  (0.00)
follow-up 23.60  (2.29) 35.20  (3.79)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1, Group 2
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.
Statistical Test of Hypothesis P-Value <.05
Comments the reported p-values correspond to the decrease compared to baseline in all arms/groups at Days 2-8
Method Mixed Models Analysis
Comments The level of statistical significance was set at .05 (two-tailed)
7.Secondary Outcome
Title Fractional Excretion of Calcium
Hide Description % = (S Creatinine X U Calcium)/(S Calcium X U Creatinine)
Time Frame baseline and daily
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description:
PTH(1-34) 2 picomols (pmols)/kg/hr
PTH(1-34) 4 picomoles/kg/hr for one week
Overall Number of Participants Analyzed 5 5
Mean (Standard Error)
Unit of Measure: % of excretion
baseline 3.38  (1.42) 1.80  (0.41)
Day 2 2.83  (0.27) 2.87  (0.71)
Day 3 4.28  (0.63) 3.76  (0.63)
Day 4 2.82  (0.51) 3.87  (0.89)
Day 5 3.90  (0.69) 2.54  (0.42)
Day 6 4.44  (0.57) 3.49  (0.69)
Day 8 5.54  (0.70) 4.58  (0.96)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.
Statistical Test of Hypothesis P-Value .002
Comments the reported p-value corresponds to the increase compared to baseline over time (days 2-8) in the PTH 2 pmol group
Method Mixed Models Analysis
Comments The level of statistical significance was set at .05 (two-tailed)
8.Secondary Outcome
Title 24 Hour Urine Calcium
Hide Description mg/gm creatinine
Time Frame 24 hours period from Day 7 to Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description:
PTH(1-34) 2 picomols (pmols)/kg/hr
PTH(1-34) 4 picomoles/kg/hr for one week
Overall Number of Participants Analyzed 5 5
Mean (Standard Error)
Unit of Measure: mg/gm creatinine
315.278845  (25.0352949) 210.24827  (58.3459645)
9.Secondary Outcome
Title Tubular Maximum for Phosphorous
Hide Description mg/dl
Time Frame baseline and daily
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description:
PTH(1-34) 2 picomols (pmols)/kg/hr
PTH(1-34) 4 picomoles/kg/hr for one week
Overall Number of Participants Analyzed 5 5
Mean (Standard Error)
Unit of Measure: mg/dl
baseline 3.80  (0.40) 3.50  (0.28)
Day 2 3.28  (0.16) 3.30  (0.13)
Day 3 3.37  (0.20) 3.11  (0.24)
Day 4 3.25  (0.27) 3.66  (0.37)
Day 5 3.19  (0.20) 3.31  (0.22)
Day 6 3.45  (0.16) 3.25  (0.17)
Day 8 3.52  (0.34) 3.43  (0.10)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1, Group 2
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.
Statistical Test of Hypothesis P-Value .61
Comments The reported p-value corresponds to change over time for the PTH 2 and PTH 4 pmol groups
Method Mixed Models Analysis
Comments The level of statistical significance was set at .05 (two-tailed)
10.Secondary Outcome
Title Serum Amino-terminal of Collagen- (sNTX)
Hide Description % change from baseline
Time Frame baseline, daily, one week follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description:
PTH(1-34) 2 picomols (pmols)/kg/hr
PTH(1-34) 4 picomoles/kg/hr for one week
Overall Number of Participants Analyzed 5 5
Mean (Standard Error)
Unit of Measure: % change from baseline
baseline 0  (0) 0  (0)
Day 2 61.8428952  (18.6263576) 77.4709521  (13.5088219)
Day 3 85.7699521  (27.761763) 85.9288044  (12.9913176)
Day 4 96.3668762  (29.0312368) 59.9595445  (18.6508014)
Day 5 107.517148  (29.2958519) 83.3701575  (21.9993233)
Day 6 150.594712  (38.2863053) 120.268081  (17.8645936)
Day 7 141.193285  (28.7484727) 109.660098  (30.4136118)
Day 8 153.72039  (38.1279427) 148.451289  (23.0512356)
follow-up 4.06445076  (8.25178671) 1.05486408  (11.8266679)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1, Group 2
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.
Statistical Test of Hypothesis P-Value <.008
Comments The reported p-value corresponds to the % increase compared to baseline in all Arms/groups on Days 2-8
Method Mixed Models Analysis
Comments The level of statistical significance was set at .05 (two-tailed)
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group 1, Group 2
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.
Statistical Test of Hypothesis P-Value >0.05
Comments The reported p-value corresponds the the % change from baseline at follow-up in all Arms/groups
Method Mixed Models Analysis
Comments The level of statistical significance was set at .05 (two-tailed)
11.Secondary Outcome
Title Serum Carboxy-terminal of Collagen- 1(sCTX)
Hide Description % change from baseline
Time Frame baseline, daily, one week follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description:
PTH(1-34) 2 picomols (pmols)/kg/hr
PTH(1-34) 4 picomoles/kg/hr for one week
Overall Number of Participants Analyzed 5 5
Mean (Standard Error)
Unit of Measure: % change from baseline
baseline 0  (0) 0  (0)
Day 2 113.70  (37.63) 104.07  (11.83)
Day 3 136.76  (45.34) 112.11  (22.41)
Day 4 142.66  (46.55) 70.74  (37.02)
Day 5 165.97  (55.34) 92.13  (36.22)
Day 6 205.39  (60.11) 141.66  (17.80)
Day 7 206.06  (60.02) 168.77  (31.35)
Day 8 225.04  (63.07) 244.50  (25.28)
follow-up -6.78  (13.40) -11.82  (17.86)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1, Group 2
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.
Statistical Test of Hypothesis P-Value <.0001
Comments The reported p-value corresponds to % change (increase) from baseline in all Arms/groups at Days 2-8.
Method Mixed Models Analysis
Comments The level of statistical significance was set at .05 (two-tailed)
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group 1, Group 2
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.
Statistical Test of Hypothesis P-Value >0.05
Comments The reported p-value corresponds the the % change from baseline at follow-up in all Arms/groups
Method Mixed Models Analysis
Comments The level of statistical significance was set at .05 (two-tailed)
12.Secondary Outcome
Title Amino-terminal Peptides of Procollagen- 1(P1NP)
Hide Description % change from baseline
Time Frame baseline, daily, one week follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description:
PTH(1-34) 2 picomols (pmols)/kg/hr
PTH(1-34) 4 picomoles/kg/hr for one week
Overall Number of Participants Analyzed 5 5
Mean (Standard Error)
Unit of Measure: % change from baseline
baseline 0  (0) 0  (0)
Day 2 -18.536953  (3.06129512) -16.118573  (9.23396676)
Day 3 -31.14427  (3.986728) -35.577655  (3.47737847)
Day 4 -32.942391  (1.15253446) -35.018736  (5.91933273)
Day 5 -31.506308  (2.94297475) -35.309609  (6.61031904)
Day 6 -36.35864  (5.71685066) -35.064188  (5.84391487)
Day 7 -40.709396  (5.7024817) -30.58629  (3.41615735)
Day 8 -39.046467  (4.79183284) -35.619862  (3.18918608)
follow-up 31.4333667  (9.87895156) 26.3367446  (16.1801142)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1, Group 2
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.
Statistical Test of Hypothesis P-Value <.0001
Comments the reported p-value corresponds to % decrease compared to baseline at Days 2-8 in all Arms/groups
Method Mixed Models Analysis
Comments The level of statistical significance was set at .05 (two-tailed)
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group 1, Group 2
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.
Statistical Test of Hypothesis P-Value .01
Comments the reported p-value corresponds to % change from baseline at the follow-up visit in all Arms/groups
Method Mixed Models Analysis
Comments the reported p-value corresponds to % change from baseline at the follow-up visit in all Arms/groups
13.Secondary Outcome
Title Bone Specific Alkaline Phosphatase (BSAP)
Hide Description % change from baseline
Time Frame baseline, daily, one week follow-up
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1 Group 2
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PTH(1-34) 2 picomols (pmols)/kg/hr
PTH(1-34) 4 picomoles/kg/hr for one week
Overall Number of Participants Analyzed 5 5
Mean (Standard Error)
Unit of Measure: % change from baseline
baseline 0  (0) 0  (0)
Day 2 7.35  (3.22) 7.91  (7.47)
Day 3 -5.61  (4.67) 9.05  (12.82)
Day 4 4.34  (4.85) 0.77  (9.93)
Day 5 -8.75  (3.39) -2.19  (14.10)
Day 6 -3.42  (15.55) -8.89  (11.60)
Day 7 -1.35  (12.69) -13.72  (12.96)
Day 8 2.09  (11.94) -9.91  (16.98)
follow-up 14.08  (9.96) 5.51  (8.28)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1, Group 2
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.
Statistical Test of Hypothesis P-Value >.05
Comments the reported p-value corresponds to % change compared to baseline at Days 2-8 in all Arms/groups
Method Mixed Models Analysis
Comments The level of statistical significance was set at .05 (two-tailed)
Time Frame 12 hours after the infusion was started then q 8 hours for 7 days, Follow-up 1 week after infusion complete
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description PTH (1-34) 2 picomoles (pmols)/kg/hr PTH (1-34) 4 picomoles (pmols)/kg/hr
All-Cause Mortality
Group 1 Group 2
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Group 1 Group 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/6 (0.00%)      0/5 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group 1 Group 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/6 (16.67%)      2/5 (40.00%)    
Endocrine disorders     
hypercalcemia   0/6 (0.00%)  0 1/5 (20.00%)  1
tachycardia   0/6 (0.00%)  0 1/5 (20.00%)  1
IV infiltration   1/6 (16.67%)  1 0/5 (0.00%)  0
Indicates events were collected by systematic assessment
Small number of subjects in each group Study limited to Caucasians Only one timepoint for follow-up was measure Study did not include saline infused controls
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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
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Name/Title: Mara J Horwitz
Organization: University of Pittsburgh
Phone: 412-692-2848
EMail: horwitz@pitt.edu
Publications:
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Responsible Party: Mara Horwitz, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00377312    
Other Study ID Numbers: 0606127
R01DK073039 ( U.S. NIH Grant/Contract )
First Submitted: September 14, 2006
First Posted: September 18, 2006
Results First Submitted: April 25, 2014
Results First Posted: March 22, 2016
Last Update Posted: March 22, 2016