Clinical Trials Register

Summary
EudraCT Number:	2011-006152-36
Sponsor's Protocol Code Number:	1774
National Competent Authority:	Denmark - DHMA
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2012-05-10
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Denmark - DHMA

A.2

EudraCT number

2011-006152-36

A.3

Full title of the trial

Postoperative treatment with parathyroidea hormone Forteo® in
patients undergoing posterolateral spinal fusion surgery. A prospektive
and a randomized double-blinded, placebo-controlled study

Parathyroidea hormon behandling ved non-instrumenteret posterolateral
spondylodese.
- Prospektivt, dobbeltblindet, randomiseret placebo kontrolleret studie

A.3.1

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

Does postoperative treatment with parathyroidea hormone Forteo®
improve the disability in
elderly patients undergoing spinal stabilization fusion surgery compared
with patients treated with placebo. If that is the case, is there a correlation
between improvement of disability and solid osseous healing?

Kan parathyroidea hormon (PTH) i form af lægemidlet Forsteo forbedre
funktionsniveauet ved uinstrumenteret stivgørende operation i
lænderyggen på ældre patienter, i forhold til placebobehandling. I så fald
kan denne forbedring, forklares ved at patienterne opnår en forbedret
knogleheling?

A.3.2

Name or abbreviated title of the trial where available

PTH-U-DESE-STUDY

PTH-U-DESE-STUDIET

A.4.1

Sponsor's protocol code number

1774

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	Middelfart Rygsektor
B.1.3.4	Country
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	Eli Lilly
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Rygkirurgisk forskningsenhed, SLB
B.5.2	Functional name of contact point	Karen Højmark
B.5.3	Address:
B.5.3.1	Street Address	Østre Hougvej 55
B.5.3.2	Town/ city	Middelfart
B.5.3.3	Post code	5500
B.5.4	Telephone number	004563484198
B.5.5	Fax number	004563484281

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	Forteo
D.2.1.1.2	Name of the Marketing Authorisation holder	Eli Lilly
D.2.1.2	Country which granted the Marketing Authorisation	Denmark
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	Forsteo
D.3.2	Product code	0002-8971
D.3.4	Pharmaceutical form	Solution for injection in pre-filled pen
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	teriparatide [rDNA origin] contains recombinant human parathyroid hormone (1-34)
D.3.9.1	CAS number	52232-67-4
D.3.9.3	Other descriptive name	rhPTH (1-34)
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	20
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	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Injection
D.8.4	Route of administration of the placebo	Subcutaneous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Spinal stenosis

Spinal stenose

E.1.1.1

Medical condition in easily understood language

Spinal stenosis, a painful condition which often results in reduced
walking distance. It is caused by compression of neural structures in the
spinal canal

Operationskrævende forsnævret rygmarvskanal(spinalstenose) betinget
af en fremadglidning af en lænderyghvirvel (spondylolisthesis).Det er en smertefuld lidelse og kan reducere patientens gangdistance.

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	LLT
E.1.2	Classification code	10041597
E.1.2	Term	Spinal stenosis of lumbar region
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 primary aim of this study is to examine the effect on
clinical outcome of postoperative treatment with Forteo® by evaluating self reported disability,(ADL functions-data) in elderly patients undergoing spinal stabilization surgery compared with
placebotreatment.

Det primære formål med projektet er, at belyse, hvorledes behandling med parathyroidea
Hormon (PTH) i form af lægemidlet Forsteo, påvirker det kliniske operationsresultatet. Vi evaluerer selvreporteret funktionsniveau, ADL funktions data præ og postoperativt efter uinstrumenteret stivgørende operation i lænderyggen på ældre patienter i forhold til
Placebobehandling.

E.2.2

Secondary objectives of the trial

The secondary objectives are to define
-if the patients walking
distance is improved
- if the level of pain is reduced.
And if a better fusionrate on CT and DEXA -scan
correlate with the functional outcome of treatment with Forteo®, i.e. if
the walking
distance is improved or the level of pain is reduced.

Det sekundære formål er, at se om patienter behandlet med Forsteo som tillægsbehandling opnår hurtigere fremskridt i forhold til placebobehandling mht. følgende
nedenstående endpoints.
• en forøgelse af gangdistance ud fra forskellen af gangdistancen præ
og postoperativt, som måles på et løbebånd i et træningsrum beliggende
ved siden af rygkirurgisk sengeafsnit, afd. R, Middelfart Sygehus.
• en forbedring af deres bensmerter vurderet ud fra en VAS-score
Samt at belyse om der er en sammenhæng imellem en evt. forbedring og visualiseret heling set på
røntgen, "thin slice CT" (CT-scanning og DEXA –
skanninger) med det kliniske operationsresultat, som f.eks. forbedring i gangdistancen eller ved reduktion af smerte.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Spinal stenosis verified by MRI
Age 60 or above
No diagnosed dementia
(MMSE 24 of 30 correct answers)
Considerable reduction in walking distance which
has not improved during conservative treatment

Spinal stenose verificeret ved MR-scanning
Alder over 60 år
Ingen demens (MMSE 24 ud af 30)
Reduceret gangdistance med kraftige bensmerter, som ikke har oplevet effekt af konservativ behandling.

E.4

Principal exclusion criteria

Contraindication for PTH treatment
Major deformity
Mental illness
Spinal cord compression due to infection or
malignant disease
Resent spinal fracture
hypercalcemia
Reduced kidney function
Metabolic bone disease, including
hypophosphatemia
Untreated anti coagulant treatment
Previous radiation therapy
Haematological disorders
Previously fusion spinal surgery
Age under 60

Kontraindikationer for PTH-behandling vurderet udfra referenceværdier
på blodprøvesvar samt anamnese. (Ophobning af calcium i blodet, stærk
nedsat nyrefunktion, knogle forstyrrende sygdomme, inkl.
hyperparathyrodisme og Mb. Paget, Ondartet lidelse.
Infection
Svær sindslidelse
Tidligere strålet behandlet
Blodsygdom (hæmatologisk sygdom)
Brud af rygsøjlen inden for det sidste år
Tidligere stivgørende rygoperation (spondylodeseoperation)
Alder under 60 år
Patienter, som har behov for tablet behandling med prednisolon.
Kontinuerlig medicinsk behandling med vitamin K antagonist
(f.eks.Warfarin)
Behersker ikke det danske sprog (læse og tale)
Alkoholisme eller stofmisbrug.
Demens vurderet ved en test (MMSE-test) (mindst 24 af 30 rigtige svar)

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint is to examine the effect and
clinical outcome of postoperative treatment with Forteo in elderly patients undergoing spinal stabilization surgery compared with placebotreatment using selfreported questionnaires evaluating disability (DPQ, SF36, ODI, and EQ-5D) præ and postoperative.

Det primære formål er, at belyse, hvorledes behandling med parathyroidea
Hormon (PTH) i form af lægemidlet Forsteo påvirker det kliniske operationsresultatet efter uinstrumenteret stivgørende operation, ved at evaluere patientens daglige selvreporteret funktionsniveau vurderet, ved at
sammenligne scoren af DPQ, SF36, ODI og EQ-5D i spørgeskemaerne præ og postoperativt.

E.5.1.1

Timepoint(s) of evaluation of this end point

By measuring the patients' state of health and disability ADL functions-data (DPQ) before at inclusion (baseline) and after
3,6,12 and 24 months.

Patienterne ses til en klinisk kontrol, hvor ADL funktions-data (DPQ) vha. spørgeskemaer opsamles og evalueres ved baseline og ved postoperative kontroller efter 3, 6, 12 og 24 måneder.

E.5.2

Secondary end point(s)

Secondary endpoints are testing the patients walking distance, level of pain (especially legpain) and use of analgesics præ and postoperative at (baseline) and after
3,6,12 and 24 months after.

Also DEXA- scans (and blood samples control for monitoring the patients calcium level) controls at OUH, Odense, where the patients' fusionrate and fusion mass are evaluated at (baseline) and after
10 days,1,3,6,12 month.
Futher “Thin slice CT” controls are evaluated postoperative at 6 and 12 months to evaluate the fusionrate.

Endvidere ønskes følgende
nedenstående kliniske sekundære endpoints belyst.
• gangdistance ud fra forskellen af gangdistancen præ
og postoperativt, som måles på et løbebånd i et træningsrum beliggende
ved siden af rygkirurgisk sengeafsnit, afd. R, Middelfart Sygehus.
• Patientens bensmerter vurderet ud fra en VAS-score.
• medicinforbrug ved at sammenligne forbruget, som oplyses i
anamnesen og i spørgeskemaerne præ og postoperativt

Endvidere bliver patientens blodprøver(calcium niveauet) kontrolleret af medicinsk rådgivende læge
på endokrinologisk, afd. M på OUH med blodprøver og DEXA
skanning, præoperativt og 10 dage, 1, 3, 6 mdr. og 12 mdr. efter
operationen. Ved samtlige postoperative kontroller i Middelfart
indsamles ADL funktions-data vha. spørgeskemaer.
6 og 12 mdr. efter operationen vil der ligeledes blive fortaget en "Thin
slice CT"-skanning af operationsområdet for at vurdere graden af
helingen.

E.5.2.1

Timepoint(s) of evaluation of this end point

Baseline (10 days and 1 month), 3,6,12 and 24 months.

Baseline (10 dage og 1 mdr), 3,6,12 and 24 mdr.

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

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.6.13.1

Other scope of the trial description

To examine whether there is a positive effect of injecting Forteo during the first postoperative period after fusion
surgery.

At evaluere om patienter behandlet med Forsteo som tillægsbehandling oplever hurtigere fremskridt i forhold til placebobehandling mht. følgende ovenstående endpoints.

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

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

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

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)

E.8.2.2

Placebo

Yes

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.8.5

The trial involves multiple Member States

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

Yes

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

The trial ends when 2 x 50 patients are treated and followed in the
randomized study. Hopefully May 2015.

Projektet afsluttes når 2X 50 patienter har været set til den sidste kliniske postoperative kontrol efter 24 måneder på Middelfart sygehus. Projektet
forventes afsluttet 1. maj 2015.

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

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

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

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

100

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)

There is no treatment or care after the patients have ended the participation in the trial

Der gives ikke nogen form for efter behandling, idet PTH ikke er selve behandlingen men et lægemiddel, som skal understøtte den oprindelige rygkirurgiske behandling.

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2012-05-10

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-01-23

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2018-06-13

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials