Trial Outcomes & Findings for Suspected Deficient Activation of Vitamin D in Patients With Secondary Hyperparathyroidism (NCT NCT00754442)

Results Overview

1,25-D was measured at baseline, 4 and 8 hours after PTH infusion

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

baseline, 4 and 8 hours after start of infusion

Results posted on

2022-04-01

Participant Flow

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

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.

Participant milestones

Participant milestones
Measure	Controls controls with normal PTH	Patient Group patients with secondary hyperparathyroidism
Overall Study STARTED	11	9
Overall Study COMPLETED	6	6
Overall Study NOT COMPLETED	5	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Controls controls with normal PTH	Patient Group patients with secondary hyperparathyroidism
Overall Study Withdrawal by Subject	5	3

Baseline Characteristics

Suspected Deficient Activation of Vitamin D in Patients With Secondary Hyperparathyroidism

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Controls n=11 Participants controls with normal PTH	Patient Group n=9 Participants patients with secondary hyperparathyroidism	Total n=20 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	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	51.8 years STANDARD_DEVIATION 4.4 • n=5 Participants	53.0 years STANDARD_DEVIATION 2.5 • n=7 Participants	52.4 years STANDARD_DEVIATION 3.8 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants	9 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline, 4 and 8 hours after start of infusion

Population: 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.

1,25-D was measured at baseline, 4 and 8 hours after PTH infusion

Outcome measures

Outcome measures
Measure	Group 1 n=5 Participants "patients" with secondary hyperparathyroidism	Controls n=5 Participants Controls without secondary hyperparathyroidism
The Level of Activated Vitamin D (1,25-dihydroxyvitamin D) After Parathyroid Hormone Infusion at Baseline, 4 and 8 Hours Baseline	40.6 pg/ml Standard Deviation 5.6	46.2 pg/ml Standard Deviation 3.7
The Level of Activated Vitamin D (1,25-dihydroxyvitamin D) After Parathyroid Hormone Infusion at Baseline, 4 and 8 Hours 4 hours	39.8 pg/ml Standard Deviation 6.0	58.8 pg/ml Standard Deviation 6.7
The Level of Activated Vitamin D (1,25-dihydroxyvitamin D) After Parathyroid Hormone Infusion at Baseline, 4 and 8 Hours 8 hours	56.4 pg/ml Standard Deviation 9.2	105 pg/ml Standard Deviation 2.3

SECONDARY outcome

Timeframe: blood samples taken at baseline and sequenced over several days

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

CYP27B1 gene (the gene for 25-hydroxyvitamin D-1-alpha hydroxylase) was sequenced for all in patient group and compared with published control data

Outcome measures

Outcome measures
Measure	Group 1 n=9 Participants "patients" with secondary hyperparathyroidism	Controls Controls without secondary hyperparathyroidism
The Number of Patients With Mutations in CYP27B1	0 participants 5	—

Adverse Events

Controls

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Patient Group

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Controls n=11 participants at risk controls with normal PTH	Patient Group n=9 participants at risk patients with secondary hyperparathyroidism
Gastrointestinal disorders vomiting	9.1% 1/11 • Number of events 1 • During PTH infusion, 2 participants, one in patient and one in control groups had one episode of vomiting each.	11.1% 1/9 • Number of events 1 • During PTH infusion, 2 participants, one in patient and one in control groups had one episode of vomiting each.

Additional Information

Elizabeth A Streeten, MD

University of Maryland School of Medicine

Phone: 410-328-6219

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place