Clinical Trials Register

Summary
EudraCT Number:	2020-005712-22
Sponsor's Protocol Code Number:	01-2020
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-06-23
Trial 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

Spain - AEMPS

A.2

EudraCT number

2020-005712-22

A.3

Full title of the trial

Prospective, randomized, multicenter study to compare the efficacy at 52 weeks (1 year) of biosimilar teriparatide and alendronate in the prevention of new morphometric vertebral fractures and / or aggravation of previous vertebral fractures in women with clinical vertebral fracture or recent hip fracture (imminent risk of fracture) and low bone mineral density.

Estudio prospectivo aleatorizado, multicéntrico, para comparar la eficacia a 52 semanas (1 año) de teriparatida biosimilar y alendronato en la prevención de nuevas fracturas vertebrales morfométricas y/o agravamiento de fracturas vertebrales previas en mujeres con fractura vertebral clínica o fractura de cadera reciente (riesgo inminente de fractura) y baja densidad mineral ósea.

A.3.1

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

IMMINENT study_Osteoporosis

Estudio IMMINENT_Osteoporosis

A.3.2

Name or abbreviated title of the trial where available

IMMINENT

A.4.1

Sponsor's protocol code number

01-2020

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	Gedeon Richter Ibérica
B.1.3.4	Country	Spain
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	Gedeon Richter Ibérica
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	TRIALANCE
B.5.2	Functional name of contact point	Mercedes Villa
B.5.3	Address:
B.5.3.1	Street Address	Pavia 8 1º1ª
B.5.3.2	Town/ city	Barcelona
B.5.3.3	Post code	08028
B.5.3.4	Country	Spain
B.5.4	Telephone number	+34636262669
B.5.6	E-mail	mvilla@trialance.com

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.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Teriparatide biosimilar
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Injection (Noncurrent)
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	Yes
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	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.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Alendronic acid
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
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	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

Osteoporosis in postmenopausal women at increased risk of fracture.

Osteoporosis en mujeres postmenopausicas con riesgo de fractura

E.1.1.1

Medical condition in easily understood language

Menopausal women with lower bone density and risk of fracture

Mujeres menopáusicas con baja densidad ósea y riesgo de fractura

E.1.1.2

Therapeutic area

Body processes [G] - Bones and nerves physological processes [G11]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.0
E.1.2	Level	PT
E.1.2	Classification code	10031290
E.1.2	Term	Osteoporotic fracture
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

To assess the efficacy of biosimilar teriparatide compared to alendronate in reducing the incidence of new morphometric vertebral fractures and / or worsening of previous ones in women older than 65 years with recent clinical vertebral fracture or hip fracture and low bone mineral density. after 52 weeks of treatment.

Evaluar la eficacia de teriparatida biosimilar en comparación con alendronato en la reducción de la incidencia de nuevas fracturas vertebrales morfométricas y/o agravamiento de previas en mujeres mayores de 65 años con fractura vertebral clínica o fractura de cadera recientes y baja densidad mineral ósea tras 52 semanas de tratamiento.

E.2.2

Secondary objectives of the trial

• Incidence of new morphometric vertebral fractures and / or aggravation of prior to 26 weeks of treatment.
• Incidence of new clinical vertebral fractures at 26 and 52 weeks.
• Incidence of moderate and severe vertebral fractures (grades 2 and 3) at 26 and 52 weeks.
• Incidence of multiple vertebral fractures at 26 and 52 weeks.
• Incidence of non-vertebral fractures at 26 and 52 weeks.
• Incidence of major non-vertebral fractures (proximal humerus, distal radius, and proximal femur) at 26 and 52 weeks.
• Changes in BMD (Bone Mineral Density) at 52 weeks.
• Changes in TBS (Trabecular Bone Score) at 52 weeks.
• Reduction of spinal pain, using a visual analog scale (VAS) at 26 and 52 weeks.
• Improvement in quality of life, using the EQ-5D questionnaire at 26 and 52 weeks.
• Adherence to treatment throughout the study.
• Safety (adverse events).

• Incidencia de nuevas fracturas vertebrales morfométricas y/o agravamiento de previas a las 26 semanas de tratamiento.
• Incidencia de nuevas fracturas vertebrales clínicas a las 26 y 52 semanas.
• Incidencia de fracturas vertebrales moderadas y severas (grados 2 y 3) a las 26 y 52 semanas.
• Incidencia de fracturas vertebrales múltiples a las 26 y 52 semanas.
• Incidencia de fracturas no vertebrales a las 26 y 52 semanas.
• Incidencia de fracturas no vertebrales principales (húmero proximal, radio distal y fémur proximal) a las 26 y 52 semanas.
• Cambios en la DMO (Densidad Mineral Ósea) a las 52 semanas.
• Cambios en el TBS (Trabecular Bone Score) a las 52 semanas.
• Reducción del dolor vertebral, mediante escala visual analógica (EVA) a las 26 y 52 semanas.
• Mejoría de la calidad de vida, mediante el cuestionario EQ-5D a las 26 y 52 semanas.
• Adherencia al tratamiento a lo largo del estudio.
• Seguridad (acontecimientos adversos).

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Women aged> 65 years.
2. Recent clinical vertebral fracture (<3 months) confirmed by radiography or recent hip (femoral neck or pretrochanteric) fracture (<3 months).
3. Low bone mineral density (BMD) (define by T-score ≤ -1 in lumbar spine, femoral neck or total hip).
4. Patients who authorize their participation in the study by signing the written informed consent.

1. Mujeres de edad > 65 años.
2. Fractura vertebral clínica reciente (< 3 meses) confirmada por radiografía o fractura de cadera (cuello de fémur o pretrocantérea) reciente (< 3 meses).
3. Densidad mineral ósea (DMO) baja (defina por T-score ≤ -1 en columna lumbar, cuello femoral o cadera total).
4. Pacientes que autorizan su participación en el estudio mediante la firma del consentimiento informado por escrito.

E.4

Principal exclusion criteria

1. Hypercalcemia.
2. Vitamin D deficiency. If the serum concentration of 25-hydroxyvitamin D is <20 ng / ml (<50 nmol / l), a supplementation with vitamin D will be carried out, according to usual clinical practice, and the analysis may be repeated. in 2-3 months and assess their inclusion.
3. Primary hyperparathyroidism.
4. Paget's disease of bone.
5. Contraindication to any of the study treatments.
6. Unexplained elevation of parathyroid hormone (PTH) or alkaline phosphatase (FA).
7. Prior use of intravenous zoledronate within 52 weeks prior to study enrollment, intravenous ibandronate or pamidronate within 3 months prior to study enrollment, denosumab within 52 weeks prior to study enrollment, or use prior parathyroid hormone, teriparatide, other analogous hormone, or sodium fluoride at therapeutic doses at any time. Pretreatment with other antiosteoporotic drugs is allowed as long as they are not being taken at the time of study inclusion.
8. Have received at least 1 dose of romosozumab at any previous time
9. Patients who for any condition (cognitive, socio-economic, etc ...) present special difficulties in adherence to treatment
10. Having presented two or more previous vertebral fractures *
11. Patients whose characteristics, according to the doctor's criteria, could benefit from more than one treatment for osteoporosis other than those in the study, such as denosumab or zoledronic acid.

1. Hipercalcemia.
2. Deficiencia de vitamina D. En caso de que la concentración sérica de 25-hidroxivitamina D sea < 20 ng/ml (< 50 nmol/l), se realizará una suplementación con vitamina D, según práctica clínica habitual, pudiendo repetir el análisis en 2-3 meses y valorar su inclusión.
3. Hiperparatiroidismo primario.
4. Enfermedad ósea de Paget.
5. Contraindicación a cualquiera de los tratamientos del estudio.
6. Elevación no explicada de la hormona paratiroidea (PTH) o de la fosfatasa alcalina (FA).
7. Uso previo de zoledronato intravenoso en las 52 semanas anteriores a la inclusión en el estudio, ibandronato o pamidronato intravenoso en los 3 meses anteriores a la inclusión en el estudio, denosumab en las 52 semanas anteriores a la inclusión en el estudio o bien uso previo de hormona paratiroidea, teriparatida, otra hormona análoga o fluoruro sódico a dosis terapéuticas en cualquier momento. Se permite el tratamiento previo con otros fármacos antiosteoporóticos siempre que no se estén tomando en el momento de la inclusión en el estudio.
8. Haber recibido al menos 1 dosis de romosozumab en cualquier momento previo
9. Los pacientes que por cualquier condición (cognitiva, socio-económica, etc...) presenten especiales dificultades a la adherencia al tratamiento
10. Haber presentado dos o más fracturas vertebrales previas*
11. Pacientes que por sus características según el criterio del médico pudieran beneficiarse más de un tratamiento para la osteoporosis diferente a los del estudio, como denosumab o ácido zoledrónico

E.5 End points

E.5.1

Primary end point(s)

Percentage of patients with at least one new morphometric vertebral fracture (incident vertebral fractures) or increased severity of a known vertebral fracture (vertebral re-fracture)

Porcentaje de pacientes con al menos una nueva fractura vertebral morfométrica (fracturas vertebrales incidentes) o el aumento de gravedad de una fractura vertebral ya conocida (re-fractura vertebral) durante el periodo de 52 semanas de estudio

E.5.1.1

Timepoint(s) of evaluation of this end point

During the 52-week study period

Durante el periodo de 52 semanas de estudio

E.5.2

Secondary end point(s)

1 Incidence of new morphometric vertebral fractures or the increase in severity of a known vertebral fracture
2. Incidence of new clinical vertebral fractures
3. Incidence of new non-vertebral fractures
4. Incidence of new major non-vertebral fractures
5. Change in bone mineral density from baseline
6. Change in the trabecular bone score with respect to the base value
7. Change in spinal pain via EVA-pain from baseline]
8. Change in quality of life through the EQ-5D questionnaire compared to baseline
9 .Evaluation of therapeutic adherence

1.Incidencia de nuevas fracturas vertebral morfométricas o el aumento de gravedad de una fractura vertebral ya conocida [inicio y a las 26 semanas].
2.Incidencia de nuevas fracturas vertebrales clínicas [inicio, a las 26 y a las 52 semanas].
3.Incidencia de nuevas fracturas no vertebrales [inicio, a las 26 y a las 52 semanas].
4.Incidencia de nuevas fracturas no vertebrales mayores [inicio, a las 26 y a las 52 semanas].
5.Cambio en la densidad ósea respecto al valor basal [inicio y a las 52 semanas].
6.Cambio en la densidad mineral ósea respecto al valor basa [inicio y a las 52 semanas].
7.Cambio en el dolor vertebral a través de la EVA-dolor respecto al valor basal [inicio, a las 10, a las 26 y a las 52 semanas]
8.Cambio en la calidad de vida a través del cuestionario EQ-5D respecto al valor basal [inicio, a las 10, a las 26 y a las 52 semanas].
9.Evaluación de la adhesión terapéutica [inicio, a las 10, a las 26 y a las 52 semanas]

E.5.2.1

Timepoint(s) of evaluation of this end point

1 Oonset and at 26 weeks.
2. Onset, at 26 and 52 weeks.
3. Onset, at 26 and 52 weeks.
4. Onset, at 26 and 52 weeks.
5. Baseline and at 52 weeks.
6. Start and at 52 weeks.
7. Baseline, at 10, 26, and 52 weeks.
8. Start, at 10, at 26 and at 52 weeks.
9 .Start at 10, 26 and 52 weeks.

1.inicio y a las 26 semanas.
2.Inicio, a las 26 y a las 52 semanas.
3.Inicio, a las 26 y a las 52 semanas.
4.Inicio, a las 26 y a las 52 semanas.
5.Inicio y a las 52 semanas.
6.Inicio y a las 52 semanas.
7.Inicio, a las 10, a las 26 y a las 52 semanas
8.inicio, a las 10, a las 26 y a las 52 semanas.
9.Evaluación de la adhesión terapéutica [inicio, a las 10, a las 26 y a las 52 semanas]

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)

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

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

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

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

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)

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

376

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

376

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)

None

Ninguno

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

2021-07-08

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-07-07

P. End of Trial
P.	End of Trial Status	Ongoing

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