Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Suspected Deficient Activation of Vitamin D in Patients With Secondary Hyperparathyroidism (1hydroxylase)

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: NCT00754442
Recruitment Status : Completed
First Posted : September 18, 2008
Results First Posted : May 14, 2014
Last Update Posted : September 4, 2019
Sponsor:
Information provided by (Responsible Party):
Elizabeth Streeten, University of Maryland, College Park

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Secondary Hyperparathyroidism
Intervention Drug: Teriparatide
Enrollment 20
Recruitment Details All in the "patient" group were recruited from the Metabolic Bone Clinic at U Md, except one, who was recruited from prior participation in the Amish Family Osteoporosis Study, recruited from 3/15/07-11/14/08
Pre-assignment Details Of 11 "controls" enrolled, 6 completed the study and 5 dropped out because they didn't want to do the parathyroid hormone (PTH) infusion. Of 9 "patients" recruited, 6 completed the study. The others were excluded after their screening labs showed that their renal function was below the inclusion criteria.
Arm/Group Title Controls Patient Group
Hide Arm/Group Description controls with normal PTH patients with secondary hyperparathyroidism
Period Title: Overall Study
Started 11 [1] 9 [2]
Completed 6 6
Not Completed 5 3
Reason Not Completed
Withdrawal by Subject             5             3
[1]
controls 11
[2]
patients 9
Arm/Group Title Controls Patient Group Total
Hide Arm/Group Description controls with normal PTH patients with secondary hyperparathyroidism Total of all reporting groups
Overall Number of Baseline Participants 11 9 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 9 participants 20 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
11
 100.0%
9
 100.0%
20
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 9 participants 20 participants
51.8  (4.4) 53.0  (2.5) 52.4  (3.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 9 participants 20 participants
Female
11
 100.0%
9
 100.0%
20
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants 9 participants 20 participants
11 9 20
1.Primary Outcome
Title The Level of Activated Vitamin D (1,25-dihydroxyvitamin D) After Parathyroid Hormone Infusion at Baseline, 4 and 8 Hours
Hide Description 1,25-D was measured at baseline, 4 and 8 hours after PTH infusion
Time Frame baseline, 4 and 8 hours after start of infusion
Hide Outcome Measure Data
Hide Analysis Population Description
The final analysis was made on participants with glomerular filtration rate (GFR) of 70 and above since <70, 1,25-D production decreases. After study completion, it was noted that one participant in each group (patient and control) had GFR<70 so these two participants were excluded from final analysis.
Arm/Group Title Group 1 Controls
Hide Arm/Group Description:
"patients" with secondary hyperparathyroidism
Controls without secondary hyperparathyroidism
Overall Number of Participants Analyzed 5 5
Mean (Standard Deviation)
Unit of Measure: pg/ml
Baseline 40.6  (5.6) 46.2  (3.7)
4 hours 39.8  (6.0) 58.8  (6.7)
8 hours 56.4  (9.2) 105  (2.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1, Controls
Comments The null hypothesis is that there is no statistical difference between patients and controls at baseline
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1
Comments see above
Method t-test, 2 sided
Comments 95%
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group 1, Controls
Comments The null hypothesis is that there is no statistical difference between patients and controls at 4 hours
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group 1, Controls
Comments The null hypothesis is that there is no statistical difference between patients and controls at 8 hrs
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title The Number of Patients With Mutations in CYP27B1
Hide Description CYP27B1 gene (the gene for 25-hydroxyvitamin D-1-alpha hydroxylase) was sequenced for all in patient group and compared with published control data
Time Frame blood samples taken at baseline and sequenced over several days
Hide Outcome Measure Data
Hide Analysis Population Description
All patients were sequenced and compared to published control data. Controls were not sequenced for cost reasons
Arm/Group Title Patients
Hide Arm/Group Description:
patients with idiopathic secondary hyperparathyroidism
Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: participants
0
Time Frame During PTH infusion, 2 participants, one in patient and one in control groups had one episode of vomiting each.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Controls Patient Group
Hide Arm/Group Description controls with normal PTH patients with secondary hyperparathyroidism
All-Cause Mortality
Controls Patient Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Controls Patient Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/11 (0.00%)      0/9 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Controls Patient Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/11 (9.09%)      1/9 (11.11%)    
Gastrointestinal disorders     
vomiting  [1]  1/11 (9.09%)  1 1/9 (11.11%)  1
Indicates events were collected by systematic assessment
[1]
One patient and one control each had one episode of vomiting during the PTH infusion. Both continued the full 8 hrs of infusion
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
Layout table for Results Point of Contact information
Name/Title: Elizabeth A Streeten, MD
Organization: University of Maryland School of Medicine
Phone: 410-328-6219
EMail: estreete@medicine.umaryland.edu
Layout table for additonal information
Responsible Party: Elizabeth Streeten, University of Maryland, College Park
ClinicalTrials.gov Identifier: NCT00754442     History of Changes
Other Study ID Numbers: H-28679
H-28679 ( Other Identifier: IRB number )
First Submitted: September 17, 2008
First Posted: September 18, 2008
Results First Submitted: January 17, 2013
Results First Posted: May 14, 2014
Last Update Posted: September 4, 2019