Trial Outcomes & Findings for Trial Of Paricalcitol and Cholecalciferol(Vitamin D3) in the Treatment Of Secondary Hyperparathyroidism in Patients After ROUX-EN-Y Gastric Bypass Surgery (NCT NCT01138475)
NCT ID: NCT01138475
Last Updated: 2017-03-22
Results Overview
Change in iPTH was compared in each arm from baseline to final measure at 6 weeks the differences were compared in the 3 arms of the study
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
49 participants
Primary outcome timeframe
6 weeks
Results posted on
2017-03-22
Participant Flow
Subjects have been recruited from our patients who underwent gastric bypass surgery. They needed to be able to give informed consent, age \> 18 years, within 12 months of RYGB being performed, post-operative iPTH \>69 pg/ml negative serum pregnancy test, serum calcium 8.0-10.5 mg/dl, phosphorus level \<5.2 mg/dl, and serum albumin \>3.0 g/dl.
Participant milestones
| Measure |
Placebo-controlled
The placebo group received a placebo capsule, 1 daily each day of the week. This was a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively).
Consenting adult participants were randomized in a 1:1:1 ratio to each treatment group and received paricalcitol capsules, cholecalciferol capsules, or placebo. Per inclusion criteria, all had previously undergone GB for the treatment of morbid obesity, were between 6 weeks and 5 years post-surgery with secondary hyperparathyroidism, defined as a serum PTH level greater than 69 pg/mL.
|
Paricalcitrol
Paricalcitriol arm received1 mcg daily each day of the week. This study was randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively).
|
Cholecalciferol
The cholecalciferol arm was treated with 5000 IU of cholecalciferol total of 35,000 IUper week.
This study was randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively).
|
|---|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
17
|
|
Overall Study
COMPLETED
|
16
|
16
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
failure to capture
Baseline characteristics by cohort
| Measure |
Paricalcitol
n=16 Participants
|
Cholecalciferol
n=17 Participants
|
Placebo
n=16 Participants
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=16 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=49 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=16 Participants
|
17 Participants
n=17 Participants
|
16 Participants
n=16 Participants
|
49 Participants
n=49 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=16 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=49 Participants
|
|
Age, Continuous
|
55 years
STANDARD_DEVIATION 9 • n=16 Participants
|
55 years
STANDARD_DEVIATION 10 • n=17 Participants
|
51 years
STANDARD_DEVIATION 11 • n=16 Participants
|
53.8 years
STANDARD_DEVIATION 9.9 • n=49 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=16 Participants
|
11 Participants
n=17 Participants
|
15 Participants
n=16 Participants
|
41 Participants
n=49 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=16 Participants
|
6 Participants
n=17 Participants
|
1 Participants
n=16 Participants
|
8 Participants
n=49 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=16 Participants
|
17 participants
n=17 Participants
|
17 participants
n=16 Participants
|
49 participants
n=49 Participants
|
|
PTH
|
96 ng/mL
STANDARD_DEVIATION 27 • n=15 Participants • failure to capture
|
90 ng/mL
STANDARD_DEVIATION 15 • n=16 Participants • failure to capture
|
101 ng/mL
STANDARD_DEVIATION 25 • n=14 Participants • failure to capture
|
96 ng/mL
STANDARD_DEVIATION 24 • n=45 Participants • failure to capture
|
|
alkaline phosphatase
|
87 u/L
STANDARD_DEVIATION 19 • n=16 Participants
|
97 u/L
STANDARD_DEVIATION 29 • n=17 Participants
|
101 u/L
STANDARD_DEVIATION 32 • n=16 Participants
|
95 u/L
STANDARD_DEVIATION 27 • n=49 Participants
|
|
serum calcium
|
9.4 mg/dL
STANDARD_DEVIATION 0.3 • n=16 Participants
|
9.3 mg/dL
STANDARD_DEVIATION 0.3 • n=17 Participants
|
9.4 mg/dL
STANDARD_DEVIATION 0.4 • n=16 Participants
|
9.3 mg/dL
STANDARD_DEVIATION 0.3 • n=49 Participants
|
|
25 OH vitamin D
|
30 ng/dL
STANDARD_DEVIATION 16 • n=16 Participants
|
32 ng/dL
STANDARD_DEVIATION 13 • n=17 Participants
|
30 ng/dL
STANDARD_DEVIATION 7 • n=16 Participants
|
30 ng/dL
STANDARD_DEVIATION 12 • n=49 Participants
|
|
serum phosphorous
|
3.9 mg/dL
STANDARD_DEVIATION 0.6 • n=15 Participants • failure to capture
|
3.7 mg/dL
STANDARD_DEVIATION 0.5 • n=16 Participants • failure to capture
|
3.7 mg/dL
STANDARD_DEVIATION 0.5 • n=15 Participants • failure to capture
|
3.7 mg/dL
STANDARD_DEVIATION 0.5 • n=46 Participants • failure to capture
|
|
24 hour urine calcium
|
89 mmol
STANDARD_DEVIATION 81 • n=15 Participants • failure to capture
|
106 mmol
STANDARD_DEVIATION 139 • n=15 Participants • failure to capture
|
131 mmol
STANDARD_DEVIATION 91 • n=16 Participants • failure to capture
|
109 mmol
STANDARD_DEVIATION 105 • n=46 Participants • failure to capture
|
|
osteocalcin
|
39 ng/mL
STANDARD_DEVIATION 19 • n=14 Participants • failure to capture
|
36 ng/mL
STANDARD_DEVIATION 17 • n=15 Participants • failure to capture
|
40 ng/mL
STANDARD_DEVIATION 20 • n=16 Participants • failure to capture
|
39 ng/mL
STANDARD_DEVIATION 19 • n=45 Participants • failure to capture
|
|
Urine N-telopeptide cross linked
|
64 nmol
STANDARD_DEVIATION 26 • n=15 Participants • failure to capture
|
73 nmol
STANDARD_DEVIATION 30 • n=14 Participants • failure to capture
|
82 nmol
STANDARD_DEVIATION 55 • n=16 Participants • failure to capture
|
73 nmol
STANDARD_DEVIATION 40 • n=45 Participants • failure to capture
|
|
bone specific alkaline phosphatase
|
15 U/L
STANDARD_DEVIATION 5 • n=15 Participants • failure to capture
|
19 U/L
STANDARD_DEVIATION 8.1 • n=15 Participants • failure to capture
|
19 U/L
STANDARD_DEVIATION 10 • n=16 Participants • failure to capture
|
18 U/L
STANDARD_DEVIATION 8.2 • n=46 Participants • failure to capture
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: missing data in paricalcitol and placebo group
Change in iPTH was compared in each arm from baseline to final measure at 6 weeks the differences were compared in the 3 arms of the study
Outcome measures
| Measure |
Paricalcitol
n=15 Participants
This is a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules,cholecalciferol capsules, and matching placebo on PTH level at 6 weeks in patients with sHPT after RYGB. The pool of patients in the Beaumont Bariatric Surgery program
Paricalcitol: 1 microgram by mouth daily for 6 weeks
|
Cholecalciferol
n=17 Participants
This is a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and matching placebo on PTH level at 6 weeks in patients with sHPT after RYGB. The pool of patients in the Beaumont Bariatric Surgery program
Cholecalciferol: 5000 IU (international units) by mouth daily for 6 weeks
|
Placebo
n=15 Participants
This is a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and matching placebo on PTH level at 6 weeks in patients with sHPT after RYGB. The pool of patients in the Beaumont Bariatric Surgery program
Placebo: Inactive substance, one capsule daily for 6 weeks
|
|---|---|---|---|
|
The Primary Outcome Measure With iPTH
|
72 pg/mL
Standard Deviation 31
|
87 pg/mL
Standard Deviation 43
|
82 pg/mL
Standard Deviation 30
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: missing 1 participant data in the paricalcitol group
This secondary outcome measure is change in alkaline phosphatase from baseline to final measure at 6 weeks differences were compared between the 3 arms of the study
Outcome measures
| Measure |
Paricalcitol
n=15 Participants
This is a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules,cholecalciferol capsules, and matching placebo on PTH level at 6 weeks in patients with sHPT after RYGB. The pool of patients in the Beaumont Bariatric Surgery program
Paricalcitol: 1 microgram by mouth daily for 6 weeks
|
Cholecalciferol
n=17 Participants
This is a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and matching placebo on PTH level at 6 weeks in patients with sHPT after RYGB. The pool of patients in the Beaumont Bariatric Surgery program
Cholecalciferol: 5000 IU (international units) by mouth daily for 6 weeks
|
Placebo
n=16 Participants
This is a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and matching placebo on PTH level at 6 weeks in patients with sHPT after RYGB. The pool of patients in the Beaumont Bariatric Surgery program
Placebo: Inactive substance, one capsule daily for 6 weeks
|
|---|---|---|---|
|
Alkaline Phosphatase
|
87 U/L
Standard Deviation 22
|
94 U/L
Standard Deviation 24
|
101 U/L
Standard Deviation 33
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: missing data from participant in paricalcitrol
This secondary outcome measure is change in serum calcium from baseline to final measure at 6 weeks differences in the 3 arms were compared
Outcome measures
| Measure |
Paricalcitol
n=15 Participants
This is a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules,cholecalciferol capsules, and matching placebo on PTH level at 6 weeks in patients with sHPT after RYGB. The pool of patients in the Beaumont Bariatric Surgery program
Paricalcitol: 1 microgram by mouth daily for 6 weeks
|
Cholecalciferol
n=17 Participants
This is a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and matching placebo on PTH level at 6 weeks in patients with sHPT after RYGB. The pool of patients in the Beaumont Bariatric Surgery program
Cholecalciferol: 5000 IU (international units) by mouth daily for 6 weeks
|
Placebo
n=16 Participants
This is a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and matching placebo on PTH level at 6 weeks in patients with sHPT after RYGB. The pool of patients in the Beaumont Bariatric Surgery program
Placebo: Inactive substance, one capsule daily for 6 weeks
|
|---|---|---|---|
|
Serum Calcium
|
9.3 mg/dL
Standard Error 0.3
|
9.4 mg/dL
Standard Error 0.3
|
9.3 mg/dL
Standard Error 0.6
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: missing data from participant in paricalcitrol arm
This secondary outcome measure is change in serum hydroxy-vitaminD from baseline to final measure at 6 weeks differences in the 3 arms were compared
Outcome measures
| Measure |
Paricalcitol
n=15 Participants
This is a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules,cholecalciferol capsules, and matching placebo on PTH level at 6 weeks in patients with sHPT after RYGB. The pool of patients in the Beaumont Bariatric Surgery program
Paricalcitol: 1 microgram by mouth daily for 6 weeks
|
Cholecalciferol
n=17 Participants
This is a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and matching placebo on PTH level at 6 weeks in patients with sHPT after RYGB. The pool of patients in the Beaumont Bariatric Surgery program
Cholecalciferol: 5000 IU (international units) by mouth daily for 6 weeks
|
Placebo
n=16 Participants
This is a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and matching placebo on PTH level at 6 weeks in patients with sHPT after RYGB. The pool of patients in the Beaumont Bariatric Surgery program
Placebo: Inactive substance, one capsule daily for 6 weeks
|
|---|---|---|---|
|
Serum 25 OH Vitamin D
|
27 ng/dL
Standard Deviation 7.2
|
38 ng/dL
Standard Deviation 15
|
25 ng/dL
Standard Deviation 7.8
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: missing data from all 3 participant arms
This secondary outcome measure is change in serum phosphorus from baseline to final measure at 6 weeks differences in the 3 arms were compared
Outcome measures
| Measure |
Paricalcitol
n=8 Participants
This is a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules,cholecalciferol capsules, and matching placebo on PTH level at 6 weeks in patients with sHPT after RYGB. The pool of patients in the Beaumont Bariatric Surgery program
Paricalcitol: 1 microgram by mouth daily for 6 weeks
|
Cholecalciferol
n=8 Participants
This is a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and matching placebo on PTH level at 6 weeks in patients with sHPT after RYGB. The pool of patients in the Beaumont Bariatric Surgery program
Cholecalciferol: 5000 IU (international units) by mouth daily for 6 weeks
|
Placebo
n=7 Participants
This is a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and matching placebo on PTH level at 6 weeks in patients with sHPT after RYGB. The pool of patients in the Beaumont Bariatric Surgery program
Placebo: Inactive substance, one capsule daily for 6 weeks
|
|---|---|---|---|
|
Serum Phosphorus
|
4.0 mg/dL
Standard Deviation 0.3
|
3.4 mg/dL
Standard Deviation 0.5
|
3.7 mg/dL
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Missing data from all 3 participant arms
This secondary outcome measure is change in osteocalcin from baseline to final measure at 6 weeks differences in the 3 arms were compared
Outcome measures
| Measure |
Paricalcitol
n=14 Participants
This is a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules,cholecalciferol capsules, and matching placebo on PTH level at 6 weeks in patients with sHPT after RYGB. The pool of patients in the Beaumont Bariatric Surgery program
Paricalcitol: 1 microgram by mouth daily for 6 weeks
|
Cholecalciferol
n=15 Participants
This is a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and matching placebo on PTH level at 6 weeks in patients with sHPT after RYGB. The pool of patients in the Beaumont Bariatric Surgery program
Cholecalciferol: 5000 IU (international units) by mouth daily for 6 weeks
|
Placebo
n=16 Participants
This is a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and matching placebo on PTH level at 6 weeks in patients with sHPT after RYGB. The pool of patients in the Beaumont Bariatric Surgery program
Placebo: Inactive substance, one capsule daily for 6 weeks
|
|---|---|---|---|
|
Osteocalcin
|
38 ng/mL
Standard Deviation 21
|
39 ng/mL
Standard Deviation 20
|
42 ng/mL
Standard Deviation 21
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Missing data from cholecalciferol and placebo participant arms
This secondary outcome measure is change in N-Telopeptide cross linked urine from baseline to final measure at 6 weeks, differences in the 3 arms were compared
Outcome measures
| Measure |
Paricalcitol
n=16 Participants
This is a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules,cholecalciferol capsules, and matching placebo on PTH level at 6 weeks in patients with sHPT after RYGB. The pool of patients in the Beaumont Bariatric Surgery program
Paricalcitol: 1 microgram by mouth daily for 6 weeks
|
Cholecalciferol
n=16 Participants
This is a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and matching placebo on PTH level at 6 weeks in patients with sHPT after RYGB. The pool of patients in the Beaumont Bariatric Surgery program
Cholecalciferol: 5000 IU (international units) by mouth daily for 6 weeks
|
Placebo
n=15 Participants
This is a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and matching placebo on PTH level at 6 weeks in patients with sHPT after RYGB. The pool of patients in the Beaumont Bariatric Surgery program
Placebo: Inactive substance, one capsule daily for 6 weeks
|
|---|---|---|---|
|
N-Telopeptide Cross Linked Urine
|
74 nmol
Standard Deviation 29
|
67 nmol
Standard Deviation 34
|
77 nmol
Standard Deviation 36
|
SECONDARY outcome
Timeframe: 6 weeksThis secondary outcome measure is change in bone specific alkaline phosphatase from baseline to final measure at 6 weeks, differences in the 3 arms were compared
Outcome measures
| Measure |
Paricalcitol
n=15 Participants
This is a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules,cholecalciferol capsules, and matching placebo on PTH level at 6 weeks in patients with sHPT after RYGB. The pool of patients in the Beaumont Bariatric Surgery program
Paricalcitol: 1 microgram by mouth daily for 6 weeks
|
Cholecalciferol
n=15 Participants
This is a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and matching placebo on PTH level at 6 weeks in patients with sHPT after RYGB. The pool of patients in the Beaumont Bariatric Surgery program
Cholecalciferol: 5000 IU (international units) by mouth daily for 6 weeks
|
Placebo
n=16 Participants
This is a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and matching placebo on PTH level at 6 weeks in patients with sHPT after RYGB. The pool of patients in the Beaumont Bariatric Surgery program
Placebo: Inactive substance, one capsule daily for 6 weeks
|
|---|---|---|---|
|
Bone Specific Alkaline Phosphatase
|
15 u/L
Standard Deviation 4.8
|
19 u/L
Standard Deviation 7.0
|
18 u/L
Standard Deviation 5.0
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Missing data from paricalcitol and cholecalciferol arms
This secondary outcome measure is change in 24-hour urine calcium from baseline to final measure at 6 weeks, differences in the 3 arms were compared
Outcome measures
| Measure |
Paricalcitol
n=15 Participants
This is a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules,cholecalciferol capsules, and matching placebo on PTH level at 6 weeks in patients with sHPT after RYGB. The pool of patients in the Beaumont Bariatric Surgery program
Paricalcitol: 1 microgram by mouth daily for 6 weeks
|
Cholecalciferol
n=15 Participants
This is a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and matching placebo on PTH level at 6 weeks in patients with sHPT after RYGB. The pool of patients in the Beaumont Bariatric Surgery program
Cholecalciferol: 5000 IU (international units) by mouth daily for 6 weeks
|
Placebo
n=16 Participants
This is a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and matching placebo on PTH level at 6 weeks in patients with sHPT after RYGB. The pool of patients in the Beaumont Bariatric Surgery program
Placebo: Inactive substance, one capsule daily for 6 weeks
|
|---|---|---|---|
|
24 Hour Urine Calcium
|
132 mg/dL
Standard Deviation 126
|
101 mg/dL
Standard Deviation 111
|
135 mg/dL
Standard Deviation 81
|
Adverse Events
Paricalcitriol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cholecalciferol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place