NCT03027557 · OUTCOME

Percent Change From Baseline in p-Tartrate-resistant Acid Phosphatase 5b (Trap5b).

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: MEDIAN
Unit: % change
Interval / dispersion: Inter-Quartile Range
Time frame: Change from baseline at 48 weeks reported.

What was measured

P-Trap5b, change from baseline at 48 weeks.

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 % change · Interval/dispersion: Inter-Quartile Range
Group	Value	Spread	Lower	Upper	Comment
Combined Treatment.	-27.8	Not reported	-34.1	-2.3	Not reported
Denosumab Monotherapy	-36.7	Not reported	-51.8	-16.4	Not reported
Placebo	2.3	Not reported	-4.9	19.6	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
-34.1
upper Limit
-2.3
value
-27.8
group Id
OG001
lower Limit
-51.8
upper Limit
-16.4
value
-36.7
group Id
OG002
lower Limit
-4.9
upper Limit
19.6
value
2.3

denoms

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

description

P-Trap5b, change from baseline at 48 weeks.

dispersion Type

Inter-Quartile Range

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

MEDIAN

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

Change from baseline at 48 weeks reported.

title

Percent Change From Baseline in p-Tartrate-resistant Acid Phosphatase 5b (Trap5b).

type

SECONDARY

unit Of Measure

% change

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

Preserved source evidence · Not medical advice