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Clinical Trial Results:
A phase IV, two-armed, randomised, cross-over study to compare the compliance of a once-a-month administration of vitamin D3 (D-CURE®) to a daily administration of a fixed-dose combination of vitamin D3 and calcium (STEOVIT FORTE®) during two periods of 6 months.

Summary
EudraCT number	2012-003417-34
Trial protocol	BE
Global end of trial date	17 Feb 2014

Results information
Results version number	v1(current)
This version publication date	23 Feb 2016
First version publication date	01 Mar 2015
Other versions
Summary report(s)	C-CURE IV-12-1 CSR synopsis

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

D-CURE-IV-12-1

ISRCTN number

US NCT number

WHO universal trial number (UTN)

Sponsor organisation name

Laboratoires SMB

Sponsor organisation address

rue de la Pastorale, Brussels, Belgium,

Public contact

CLINICAL DEPARTMENT, LABORATOIRES SMB S.A., 32 2 412 09 93, clinique@smb.be

Scientific contact

CLINICAL DEPARTMENT, LABORATOIRES SMB S.A., 32 2 412 09 93, clinique@smb.be

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

06 Jun 2014

Is this the analysis of the primary completion data?

Yes

Primary completion date

17 Feb 2014

Global end of trial reached?

Yes

Global end of trial date

17 Feb 2014

Was the trial ended prematurely?

Main objective of the trial

The aim of the present study is to assess the compliance of a once-a-month administration of vitamin D3 (D-CURE®) to a daily administration of a fixed-dose combination of vitamin D3 and calcium (STEOVIT FORTE®) during two periods of 6 months and to see their effect on the level of vitamin D.

Protection of trial subjects

No particular protection of trial subjects were taken.

Background therapy

Evidence for comparator

Actual start date of recruitment

15 Oct 2012

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Belgium: 100

Worldwide total number of subjects

100

EEA total number of subjects

100

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

After being screened for the study, volunteers were randomised in the study for two periods of 6 months during which they received each treatment according to the randomisation scheme.

Screening details

Eligible volunteers were over 50 years old and gave their informed consent.

Period 1 title

Period 1 - first 6-month treatment

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Not blinded

Blinding implementation details

Study not blinded

Are arms mutually exclusive

Yes

D-CURE

Arm description

Arm type

Experimental

Investigational medicinal product name

vitamin D3

Investigational medicinal product code

Other name

Pharmaceutical forms

Oral liquid

Routes of administration

Oral use

Dosage and administration details

One ampoule of D-CURE® 25.000 IU will be taken, orally, once a month, during 6 months.

STEOVIT FORTE

Arm description

Arm type

Active comparator

Investigational medicinal product name

vitamin D3/calcium

Investigational medicinal product code

Other name

Pharmaceutical forms

Chewable tablet

Routes of administration

Oral use

Dosage and administration details

One tablet of STEOVIT FORTE® 800 IU/1g will be taken, orally, once a day, during 6 months.

Number of subjects in period 1	D-CURE	STEOVIT FORTE
Started	50	50
After the first 6-month treatment period	50	49
Completed	50	49
Not completed	0	1
Consent withdrawn by subject	-	1

Period 2 title

Period 2 - the second 6-month treatment

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

D-CURE

Arm description

Arm type

Experimental

Investigational medicinal product name

vitamin D3

Investigational medicinal product code

Other name

Pharmaceutical forms

Oral liquid

Routes of administration

Oral use

Dosage and administration details

One ampoule of D-CURE® 25.000 IU will be taken, orally, once a month, during 6 months.

STEOVIT FORTE

Arm description

Arm type

Active comparator

Investigational medicinal product name

vitamin D3/calcium

Investigational medicinal product code

Other name

Pharmaceutical forms

Chewable tablet

Routes of administration

Oral use

Dosage and administration details

One tablet of STEOVIT FORTE® 800 IU/1g will be taken, orally, once a day, during 6 months.

Number of subjects in period 2	D-CURE	STEOVIT FORTE
Started	50	49
After the second6-month treatment	48	43
Completed	48	43
Not completed	2	6
Patient moved to Luxembourg	1	-
Adverse event, serious fatal	-	1
Consent withdrawn by subject	1	1
Adverse event, non-fatal	-	3
Lost to follow-up	-	1

Baseline characteristics

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Reporting group title

D-CURE

Reporting group description

Reporting group title

STEOVIT FORTE

Reporting group description

Reporting group values	D-CURE	STEOVIT FORTE	Total
Number of subjects	50	50	100
Age categorical
Units: Subjects
In utero	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0
Newborns (0-27 days)	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0
Children (2-11 years)	0	0	0
Adolescents (12-17 years)	0	0	0
Adults (18-64 years)	18	19	37
From 65-84 years	30	30	60
85 years and over	2	1	3
Age continuous
Units: years
median (inter-quartile range (Q1-Q3))	65.5 (57.4 to 72.7)	67.5 (61.2 to 73.8)	-
Gender categorical
Units: Subjects
Female	14	13	27
Male	36	37	73

End points

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Reporting group title

D-CURE

Reporting group description

Reporting group title

STEOVIT FORTE

Reporting group description

Reporting group title

D-CURE

Reporting group description

Reporting group title

STEOVIT FORTE

Reporting group description

Primary: Compliance over 6-month treatments periods

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End point title

Compliance over 6-month treatments periods

End point description

End point type

Primary

End point timeframe

Calculated after each 6-month treatment periods

End point values	D-CURE	STEOVIT FORTE	D-CURE	STEOVIT FORTE
Number of subjects analysed	50	49	50	49
Units: percentage	100	88	106	82

Two sample t-test

Comparison groups

D-CURE v STEOVIT FORTE

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.05

Method

t-test, 2-sided

Parameter type

Mean difference (net)

Confidence interval

Variability estimate

Standard deviation

Adverse events

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Timeframe for reporting adverse events

The adverse events were collected by the investigator during the course of the study (at each study visit).

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

17.1

Reporting group title

D-CURE

Reporting group description

D-CURE® 1 ml ampoule containing 25 000 IU/ml of cholecalciferol taken orally once a month.

Reporting group title

Steovit Forte

Reporting group description

STEOVIT FORTE® tablet containing 1000 mg of calcium and 800 IU of cholecalciferol taken orally once a day.

Serious adverse events	D-CURE	Steovit Forte
Total subjects affected by serious adverse events
subjects affected / exposed	6 / 99 (6.06%)	6 / 99 (6.06%)
number of deaths (all causes)	0	1
number of deaths resulting from adverse events	0	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intestinal adenocarcinoma
subjects affected / exposed	0 / 99 (0.00%)	1 / 99 (1.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Malignant melanoma
subjects affected / exposed	0 / 99 (0.00%)	1 / 99 (1.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Breast cancer
subjects affected / exposed	1 / 99 (1.01%)	0 / 99 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatic carcinoma
subjects affected / exposed	1 / 99 (1.01%)	0 / 99 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Injury, poisoning and procedural complications
Humerus fracture
subjects affected / exposed	1 / 99 (1.01%)	0 / 99 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Surgical and medical procedures
Hernia repair
subjects affected / exposed	1 / 99 (1.01%)	0 / 99 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cataract operation
subjects affected / exposed	1 / 99 (1.01%)	0 / 99 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Nervous system disorders
Cerebrovascular accident
subjects affected / exposed	1 / 99 (1.01%)	0 / 99 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Carotid artery stenosis
subjects affected / exposed	1 / 99 (1.01%)	0 / 99 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	0 / 99 (0.00%)	1 / 99 (1.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Social circumstances
Joint prosthesis user
subjects affected / exposed	0 / 99 (0.00%)	1 / 99 (1.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Osteoarthritis
subjects affected / exposed	0 / 99 (0.00%)	1 / 99 (1.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Infections and infestations
Abscess
subjects affected / exposed	0 / 99 (0.00%)	1 / 99 (1.01%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Erysipelas
subjects affected / exposed	1 / 99 (1.01%)	0 / 99 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	D-CURE	Steovit Forte
Total subjects affected by non serious adverse events
subjects affected / exposed	12 / 99 (12.12%)	17 / 99 (17.17%)
Gastrointestinal disorders
Constipation
subjects affected / exposed	4 / 99 (4.04%)	5 / 99 (5.05%)
occurrences all number	4	5
Nausea
subjects affected / exposed	1 / 99 (1.01%)	5 / 99 (5.05%)
occurrences all number	1	5
Infections and infestations
Bronchitis
subjects affected / exposed	7 / 99 (7.07%)	7 / 99 (7.07%)
occurrences all number	7	10

More information

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Were there any global substantial amendments to the protocol? No

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results:
A phase IV, two-armed, randomised, cross-over study to compare the compliance of a once-a-month administration of vitamin D3 (D-CURE®) to a daily administration of a fixed-dose combination of vitamin D3 and calcium (STEOVIT FORTE®) during two periods of 6 months.

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Compliance over 6-month treatments periods

Primary: Compliance over 6-month treatments periods

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

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Clinical trials

Clinical Trial Results: A phase IV, two-armed, randomised, cross-over study to compare the compliance of a once-a-month administration of vitamin D3 (D-CURE®) to a daily administration of a fixed-dose combination of vitamin D3 and calcium (STEOVIT FORTE®) during two periods of 6 months.

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Compliance over 6-month treatments periods

Primary: Compliance over 6-month treatments periods

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A phase IV, two-armed, randomised, cross-over study to compare the compliance of a once-a-month administration of vitamin D3 (D-CURE®) to a daily administration of a fixed-dose combination of vitamin D3 and calcium (STEOVIT FORTE®) during two periods of 6 months.