NCT03027557 · OUTCOME

Patients With Nephrocalcinosis, Final Scan.

Treatment of Primary Hyperparathyroidism With Denosumab and Cinacalcet. · Source last updated 2021-05-25

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: Baseline, one year

What was measured

Number of subjects w. renal calcifications at final scan.

Analysis population: One participant from the combined treatment-group was not included in the analysis due to withdrawal before the final blood-sampling.

Groups in this outcome

Combined Treatment.

15 subjects were treated with combined 60mg denosumab every six months, 30 mg cinacalcet daily and 50 micrograms vitamin-D3 daily.

Denosumab Monotherapy

16 subjects received 60 mg denosumab every six months, placebo and 50 micrograms vitamin-D daily.

Placebo

15 subjects will receive a saline injection every six months(blinded), placebo-tablets and 50 micrograms vitamin-D daily.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Combined Treatment.	14
Denosumab Monotherapy	16
Placebo	15

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Combined Treatment.	2	Not reported	Not reported	Not reported	Not reported
Denosumab Monotherapy	1	Not reported	Not reported	Not reported	Not reported
Placebo	3	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
2
group Id
OG001
value
1
group Id
OG002
value
3

denoms

counts
group Id
OG000
value
14
group Id
OG001
value
16
group Id
OG002
value
15
units
Participants

description

Number of subjects w. renal calcifications at final scan.

groups

description
15 subjects were treated with combined 60mg denosumab every six months, 30 mg cinacalcet daily and 50 micrograms vitamin-D3 daily.
id
OG000
title
Combined Treatment.
description
16 subjects received 60 mg denosumab every six months, placebo and 50 micrograms vitamin-D daily.
id
OG001
title
Denosumab Monotherapy
description
15 subjects will receive a saline injection every six months(blinded), placebo-tablets and 50 micrograms vitamin-D daily.
id
OG002
title
Placebo

param Type

COUNT_OF_PARTICIPANTS

population Description

One participant from the combined treatment-group was not included in the analysis due to withdrawal before the final blood-sampling.

reporting Status

POSTED

time Frame

Baseline, one year

title

Patients With Nephrocalcinosis, Final Scan.

type

SECONDARY

unit Of Measure

Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice