NCT03027557 · OUTCOME

Percentage Change in 1/3 Forearm Bone Mineral Density

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: MEAN
Unit: % change
Interval / dispersion: Standard Error
Time frame: Baseline,one year

What was measured

Percentage change of Bone Mineral Density after one year of treatment from baseline. Measured with Dual-energy X-ray absorptiometry (DXA)-scan.

Analysis population: One participant from the combined treatment-group was not included in the analysis due to withdrawal before the final scan. One participant from the denosumab group did not provide results for this analysis as he/she experienced a wrist fracture prior to the final scan.

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	15
Placebo	15

Reported measurements

Source class 1

Values in % change · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Combined Treatment.	0.94	0.7	Not reported	Not reported	Not reported
Denosumab Monotherapy	0.88	0.5	Not reported	Not reported	Not reported
Placebo	-0.91	0.7	Not reported	Not reported	Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

group Ids
OG000
OG001
OG002
non Inferiority Type
SUPERIORITY
p Value
= 0.081
statistical Method
ANOVA

Complete source fields

analyses

group Ids
OG000
OG001
OG002
non Inferiority Type
SUPERIORITY
p Value
= 0.081
statistical Method
ANOVA

classes

categories
measurements
group Id
OG000
spread
0.7
value
0.94
group Id
OG001
spread
0.5
value
0.88
group Id
OG002
spread
0.7
value
-0.91

denoms

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

description

Percentage change of Bone Mineral Density after one year of treatment from baseline. Measured with Dual-energy X-ray absorptiometry (DXA)-scan.

dispersion Type

Standard Error

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

MEAN

population Description

One participant from the combined treatment-group was not included in the analysis due to withdrawal before the final scan. One participant from the denosumab group did not provide results for this analysis as he/she experienced a wrist fracture prior to the final scan.

reporting Status

POSTED

time Frame

Baseline,one year

title

Percentage Change in 1/3 Forearm Bone Mineral Density

type

PRIMARY

unit Of Measure

% change

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

Preserved source evidence · Not medical advice