Clinical Trials Register

Summary
EudraCT Number:	2015-005303-91
Sponsor's Protocol Code Number:	VIT_D_2015
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2020-11-04
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2015-005303-91

A.3

Full title of the trial

Clinical Trial of pharmacokinetics of calcifediol (25OHD3) in women with postmenopausal osteoporosis

Studio sui lievelli circolanti di 25OHD3 in donne affette da osteoporosi postmenopausale trattate con calcifediolo

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Clinical Trial of pharmacokinetics of calcifediol (25OHD3) in women with postmenopausal osteoporosis

Studio sui lievelli circolanti di 25OHD3 in donne affette da osteoporosi postmenopausale trattate con calcifediolo

A.3.2

Name or abbreviated title of the trial where available

VIT_D_2015

A.4.1

Sponsor's protocol code number

VIT_D_2015

A.5.4

Other Identifiers

Name:

VIT_D_2015

Number:

VIT_D_2015

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	AZIENDA OSPEDALIERA UNIVERSITARIA SENESE
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Bruno Farmaceutici
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Azienda Ospedaliera Senese
B.5.2	Functional name of contact point	UOC Medicina Interna 1
B.5.3	Address:
B.5.3.1	Street Address	Viale Bracci 16
B.5.3.2	Town/ city	Siena
B.5.3.3	Post code	53100
B.5.3.4	Country	Italy
B.5.4	Telephone number	0577585468
B.5.5	Fax number	0577233446
B.5.6	E-mail	gonnelli@unisi.it

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	DIDROGYL - 1.5 MG/10 ML GOCCE ORALI, SOLUZIONEFLACONE 10 ML
D.2.1.1.2	Name of the Marketing Authorisation holder	BRUNO FARMACEUTICI S.P.A.
D.2.1.2	Country which granted the Marketing Authorisation	Italy
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	didrogyl
D.3.2	Product code	024139014
D.3.4	Pharmaceutical form	Oral solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Ocular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	CALCIFEDIOLO
D.3.9.1	CAS number	19356-17-3
D.3.9.2	Current sponsor code	19356-17-3
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	DIDROGYL - 1.5 MG/10 ML GOCCE ORALI, SOLUZIONEFLACONE 10 ML
D.2.1.1.2	Name of the Marketing Authorisation holder	BRUNO FARMACEUTICI S.P.A.
D.2.1.2	Country which granted the Marketing Authorisation	Italy
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	didrogyl
D.3.2	Product code	024139014
D.3.4	Pharmaceutical form	Oral solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	CALCIFEDIOLO
D.3.9.1	CAS number	19356-17-3
D.3.9.2	Current sponsor code	19356-17-3
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

postmenopausal osteoporosis

osteoporosi postmenopausale

E.1.1.1

Medical condition in easily understood language

postmenopausal osteoporosis

osteoporosi postmenopausale

E.1.1.2

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	HLGT
E.1.2	Classification code	10013296
E.1.2	Term	Bone, calcium, magnesium and phosphorus metabolism disorders
E.1.2	System Organ Class	10027433 - Metabolism and nutrition disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evaluate the pharmacokinetic of 25(OH)D3 in postmenopausal women with osteoporosis treated for 6 months with two different dosages of calcifediol.
To evaluate the efficacy of two different dosages of calcifediol in the achievement of serum levels of 25(OH)D3 higher than 30 ng/ml in women with postmenopausal osteoporosis.

Valutare la farmacocinetica plasmatica del 25OHD3 in un periodo di 24 settimane in donne affette da ospteoporosi postmenopausale e trattate con due diverse dosi di calcifediolo.
Valutare l¿efficacia di due diversi dosaggi di calcifediolo nel raggiungimento di livelli di 25OHD3 nel range di normalit¿ in donne affette da osteoporosi postmenopausale.

E.2.2

Secondary objectives of the trial

To evaluate the serum levels of 1-25(OH)2D3 and of PTH in postmenopausal women with osteoporosis treated for 6 months with two different dosages of calcifediol.
To evaluate the effects of two different dosages of calcifediol on muscular performances.
To evaluate the effects of two different dosages of calcifediol on serum levels of myostatin.

Valutare di livelli di 1-25OHD3 e PTH in donne osteoporotiche trattate con diversi dosaggi di calcediolo.
Valutare l¿effetto dei due diversi dosaggi di calcifediolo sulla performance muscolare.
Valutare l¿effetto dei due diversi dosaggi di calcifediolo sui livelli circolanti di miostatina.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Post-menopausal women (amenorrea for at least 5 years).
Age between 55 and 70 years
Lumbar or Femoral T-score (DXA) = - 2.5 DS
Serum levels of 25(OH)D3 between 10 and 20 ng/ml
Informed Consent signed
Willingness and capacity to adhere to study protocol.

Donne in epoca postmenopausale (amenorrea) da almeno 5 anni
Età compresa tra 55 e 70 anni
T-score lombare o femorale = -2.5 DS
Livelli plasmatici di 25OHD3 compresi tra 10 e 20 ng/ml

E.4

Principal exclusion criteria

Femoral T-score (DXA) = -3.0 DS
History of fragility fractures
Osteomalacia or Paget disease of bone
Secondary Osteoporosis (primary or secondary hyperparathyroidism, Cushings disease,etc)
Treatment with oestrogen, drugs for osteoporosis or drugs known to interfere with bone metabolism (glucocorticoids, anticonvulsants, heparin, antiretrovirals etc)
Diabetes Mellitus Type 1 and 2
Neoplastic Diseases
BMI < 18 or >29.9 kg/m2
Treatment with calcifediol, calcitriol or colecalciferol in the previous 2 months
Mental and cognitive disorders
Inability or unwillingness to adhere to the study protocol
Refuse to sign the informed Consent.

Valori di T-score a livello del femore = -3.0 DS,
Presenza di fratture da fragilità,
Osteomalacia o morbo di Paget,
Osteoporosi secondarie (iperparatiroidsmo primitivo o secondario, iperprolattinemia, etc...)
Assunzione di estrogeni, farmaci per il trattamento dell'osteoporosi o farmaci noti per avere interferenza sul metabolismo osseo (antiepilettici, cortisonici, antiretrovirali, eparina etc..).
Diabete mellito di tipo 1 e 2
Body Mass Index inferiore a 18 o superiore a 29.9 kg/mq
Somministrazione di calcifediolo o calcitriolo o colecalciferolo nei due mesi precedenti
Patologie neoplastiche
Disturbo cognitivo grave
Incapacità a rispondere alle domande
Rifiuto di firmare il consenso informato

E.5 End points

E.5.1

Primary end point(s)

a) to evaluate the pharmacokinetic of 25(OH)D3 in postmenopausal women with osteoporosis treated for 6 months with two different dosages of calcifediol.
b) to evaluate the efficacy of two different dosages of calcifediol in the achievement of serum levels of 25(OH)D3 higher than 30 ng/ml in women with postmenopausal osteoporosis.

a) concentrazione di 25OHD3 a tempo 0, 15 g.g, 1 mese, 2 mesi, 3 mesi e 6 mesi.
b) raggiungimento di livelli di 25OHD3 superiori a 30 ng/ml ai tempi 1 mese, 2 mesi, 3 mesi e 6 mesi.

E.5.1.1

Timepoint(s) of evaluation of this end point

a) 0, 15 g.g, 1 month, 2 months, 3 months and 6 months.
b) 1 month, 2 months, 3 months and 6 months.

a) a tempo 0, 15 g.g, 1 mese, 2 mesi, 3 mesi e 6 mesi.
b) ai tempi 1 mese, 2 mesi, 3 mesi e 6 mesi.

E.5.2

Secondary end point(s)

a) To evaluate the serum levels of 1-25(OH)2D3 and of PTH in postmenopausal women with osteoporosis treated for 6 months with two different dosages of calcifediol.
b) To evaluate the effects of two different dosages of calcifediol on muscular performances.
c) To evaluate the effects of two different dosages of calcifediol on serum levels of myostatin.

a) concentrazione di livelli di 1-25OHD3 a tempo 0, 15 g.g, 1 mese, 2 mesi, 3 mesi e 6 mesi.
b) valutazione della performance muscolare tramite handgrip e test di Tinetti a tempo 0, 1 mese, 2 mesi, 3 mesi e 6 mesi.
c) concentrazione di miostatina a tempo 0, 1 mese, 2 mesi, 3 mesi e 6 mesi.

E.5.2.1

Timepoint(s) of evaluation of this end point

a) 0, 15 g.g, 1 month, 2 months, 3 months e 6 months.
b) 0, 1 month, 2 months, 3 months and 6months.
c) 0, 1 months, 2 months, 3 months and 6 months.

a) a tempo 0, 15 g.g, 1 mese, 2 mesi, 3 mesi e 6 mesi.
b) a tempo 0, 1 mese, 2 mesi, 3 mesi e 6 mesi.
c) a tempo 0, 1 mese, 2 mesi, 3 mesi e 6 mesi.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Not provided any treatment.

Non previsto alcun trattamento.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2016-07-04

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-06-20

P. End of Trial
P.	End of Trial Status	Completed

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