Clinical Trials Register

Summary
EudraCT Number:	2005-000730-20
Sponsor's Protocol Code Number:	FP-001-IM
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:	2006-08-30
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

2005-000730-20

A.3

Full title of the trial

An open-label, international, multi center, parallel group, phase IIIb, randomised trial investigating lumbar spine Bone Mineral Density (BMD) changes in postmenopausal women with primary osteoporosis initially treated with 12 months of full lentght parathyroid hormone (PTH 1-84)followed by 12 months of treatment with risedronate followed by either 12 months treatment with PHT (1-84) or risedronate

A.4.1

Sponsor's protocol code number

FP-001-IM

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	TAKEDA PHARMA A/S
B.1.3.4	Country	Denmark
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

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	PREOTACT
D.2.1.1.2	Name of the Marketing Authorisation holder	NYCOMED ITALIA Srl
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.3.4	Pharmaceutical form	Powder and solvent for solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	NA
D.3.9.2	Current sponsor code	PTH (1/84)
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.3	Concentration number	100
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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	Yes
D.3.11.13.1	Other medicinal product type	Non Applicabile
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
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	PREOTACT
D.2.1.1.2	Name of the Marketing Authorisation holder	NYCOMED ITALIA Srl
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.3.4	Pharmaceutical form	Film-coated tablet
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.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.3	Concentration number	35
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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	Yes
D.3.11.13.1	Other medicinal product type	Non Applicabile

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

post-menopausal women with osteoporosis

donne in post-menopausa con osteoporosi

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	14.1
E.1.2	Level	PT
E.1.2	Classification code	10031285
E.1.2	Term	Osteoporosis postmenopausal
E.1.2	System Organ Class	10028395 - Musculoskeletal and connective tissue 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

The objective is to show superior efficacy of PTH (1-84) over risedronate in treating osteoporotic women for 12 months after having previously been treated with PTH (1-84) for 12 months followed by 12 months treatment with risedronate.

Dimostrare la superiorita' di efficacia di PTH (1-84) rispetto a risedronato nel trattamento dell'osteoporosi per un periodo di 12 mesi successivo a un precedente trattamento con PTH (1-84) per 12 mesi, seguito da 12 mesi di trattamento con risenodrato.

E.2.2

Secondary objectives of the trial

not applicable

non applicabile

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

ALTRI SOTTOSTUDI:
Bone biopsy sub study, implemented by Amendment 3 dated 4-Jan-07, as approved by EMEA on 27-Feb-08: Between weeks 148 to 156 (end of trial period III), a bone biopsy will be performed 5-7 days after two 2-day oral tetracycline labelling given with a 10-day interval. It is expected that a minimum of 24 and a maximum of 50 patients will participate in this sub study. The objective of this sub study is to evaluate the relative histomorphometric parameters in subjects receiving PTH(1-84) in trial period III compared to risedronate and to further confirm the safety of PTH(1-84) treatment.The primary efficacy endpoint for the bone biopsy sub trial is the standard histomorphometric measurement Bone Formation Rate.

E.3

Principal inclusion criteria

1. Has the subject given informed consent according to local requirements before any trial related activities? (A trial related activity is any procedure that would not have been performed during the routine management of the subject). 2. Is the subject above 50 years old? 3. Is the subject postmenopausal (more than 5 years) - in the judgement of the investigator? 4. Does the subject have primary osteoporosis with a lumbar spine T score equal to or less than -3.0 SD (at lumbar spine L1-L4, with a minimum of two evaluable vertebrae)? 5. Does the subject have a life expectancy of >3 years? 6. Is the subject able to self-inject PTH (1-84), (or to have PTH (1-84) injection by a helper)? Bone biopsy sub trial: 7. Has the subject given consent to having a bone biopsy performed? 8. Has the subject completed trial period II in FP-001-IM?</

E.4

Principal exclusion criteria

1.Is the subject currently in treatment with Selective Estrogen Receptor Modulators (SERMs) (e.g.raloxifen)? If the SERM treatment is terminated the subject can still be evaluated for eligibility.2.Has the subject ever been treated with any bisphosphonate other than alendronate or risedronate? 3.Has the subject been treated with alendronate or risedronate for more than 3 years in total? 4.Has the subject during lifetime been treated with both alendronate and risedronate, including sequential treatment? 5.Has the subject during lifetime been treated with strontium > 3 months in total? 6.Has the subject during lifetime been treated with fluoride > 3 months in total? 7.Has the subject during lifetime been treated with teriparatide or PTH (1-84)? 8.Has the subject during lifetime been treated with calcitonin during the last 3 months? 9.Is the subject currently receiving antiepileptic medication? 10.Does the subject take any other medication, that according to investigator`s opinion, is known to affect bone metabolism? 11.Has the subject received or is the subject currently receiving chronic glucocorticosteroid treatment? Defined as more or equal to: `5.0mg prednisolon or equivalent daily for 3 months during the last year or `2.5mg prednisolon or equivalent daily for 6 months during the last year 12.Has the subject ever received radiation therapy to the skeleton? 13.Has the subject been treated for cancer (other than basocellular skin cancer) within the last 5 years? 14.Has the subject ever had malignant disease affecting the skeleton? 15.Has the subject ever had breast cancer? 16.Does the subject have any known clinically significant diseases affecting calcium metabolism? 17.Does the subject have any known history of metabolic bone diseases other than primary osteoporosis (including hyperparathyroidism, Paget`s disease, osteogenesis imperfecta, or osteomalacia)? 18.Does the subject have a medical history of abnormalities in oesophagus prohibiting emptying of oesophagus (e.g.achalasia or stricture) and inability to ingest risedronate (should be able to take risedronate upright) judged by the investigator to be significant? 19.Does the subject have any known history of hypersensitivity to parathyroid hormone or risedronate or any of the excipients in the products? 20.Does the subject have any clinically significant conduction abnormalities e.g.second degree atrial ventricular block as assessed by the investigator based on ECG reading? 21.Does the subject have a plasma 25-hydroxyvitamin D level <9.2ng/ml after at least 14 days of calcium and vitamin D supplementation? 22.Does the subject have a plasma PTH of > 65pg/ml and a total serum calcium value >2.49 mmol/l? 23.Does the subject have hypercalcaemia (total serum calcium value >2.55mmol/l) after at least 14 days of calcium supplementation? 24.Does the subject have a clinically significant elevation of serum alkaline phosphatase judged by the investigator? 25.Does the subject have impaired kidney function with creatinine clearance <30ml/min (indirect measurement by serum creatinine)? 26.Does the subject have a 24 hours urinary calcium > 360mg after at least 14 days of calcium supplementation? 27.Has the subject ever shown intolerance to any bisphosphonate? 28.Is the subject scheduled for vertebroplasty? 29.Has the subject participated in a clinical trial with an Investigational Medicinal Product (IMP) during the last 30 days or does the subject plan to participate in such within the next 3 years? (Participation in non-interventional trials is allowed) Bone biopsy sub trial: 30.Does the subject have an International Normalized Ratio (INR) > 1.2 measured the earliest 1 month before the planed bone biopsy? 31.Is the patient currently in anti-coagulation therapy?

E.5 End points

E.5.1

Primary end point(s)

Primary efficacy parameter: `Change in lumbar spine BMD (measured by Dual X-ray Absorptiometry (DXA)) from start of trial period III to end of trial period III.

Parametro di efficacia primaria `Variazione nella densita` minerale ossea della colonna lombare (misurata mediante densitometria a doppio raggio (DXA)) dall`inizio del periodo di studio III alla fine del medesimo.

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

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

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)

Yes

E.7.4

Therapeutic use (Phase IV)

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

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

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

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

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	No
F.1.1	Number of subjects for this age range:	0
F.1.1.1	In Utero	No
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	No
F.1.1.3	Newborns (0-27 days)	No
F.1.1.4	Infants and toddlers (28 days-23 months)	No
F.1.1.5	Children (2-11years)	No
F.1.1.6	Adolescents (12-17 years)	No
F.1.2	Adults (18-64 years)	Yes
F.1.3	Elderly (>=65 years)	Yes
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	No
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	No
F.3.3.1	Women of childbearing potential not using contraception	No
F.3.3.2	Women of child-bearing potential using contraception	No
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	60
F.4.2	For a multinational trial
F.4.2.1	In the EEA	290
F.4.2.2	In the whole clinical trial	390

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

2006-08-01

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2006-06-02

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2011-01-14

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