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

• ClinicalTrials.gov Identifier: NCT00754442
• Recruitment Status: Completed
• First Posted: September 18, 2008
• Results First Posted: May 14, 2014
• Last Update Posted: November 4, 2019
• Sponsor: University of Maryland, Baltimore
• 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

Participant Flow

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
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

Baseline Characteristics

Arm/Group Title		Controls	Patient Group	Total
Arm/Group Description		controls with normal PTH	patients with secondary hyperparathyroidism	Total of all reporting groups
Overall Number of Baseline Participants		11	9	20
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

Outcome Measures

1. Primary Outcome

Title	The Level of Activated Vitamin D (1,25-dihydroxyvitamin D) After Parathyroid Hormone Infusion at Baseline, 4 and 8 Hours
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

Outcome Measure Data

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
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)

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%

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]

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
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

Outcome Measure Data

Analysis Population Description

All patients were sequenced and compared to published control data. Controls were not sequenced for cost reasons

Arm/Group Title	Patients
Arm/Group Description:	patients with idiopathic secondary hyperparathyroidism
Overall Number of Participants Analyzed	9
Measure Type: Number; Unit of Measure: participants
	0

Adverse Events

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
Arm/Group Description	controls with normal PTH		patients with secondary hyperparathyroidism
All-Cause Mortality
	Controls		Patient Group
	Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--
Serious Adverse Events
	Controls		Patient Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0.00%)		0/9 (0.00%)
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

Limitations and Caveats

[Not Specified]

More Information

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

• Name/Title: Elizabeth A Streeten, MD
• Organization: University of Maryland School of Medicine
• Phone: 410-328-6219
• EMail: estreete@medicine.umaryland.edu

Publications of Results:

Streeten EA, Rogstad AS, Flammer KM, Zarbalian K, Ryan K, Horwitz M, Holick MF, Shelton J. Reduced parathyroid hormone-stimulated 1,25-dihydroxyvitamin d production in vitamin d sufficient postmenoposual women with low bone mass and idiopathic secondary hyperparathyroidism. Endocr Pract. 2013 Jan-Feb;19(1):91-9. doi: 10.4158/EP12151.OR.

• Responsible Party: Elizabeth Streeten, University of Maryland, College Park
• ClinicalTrials.gov Identifier: NCT00754442
• 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: November 4, 2019