Clinical Trials Register

Summary
EudraCT Number:	2019-004766-17
Sponsor's Protocol Code Number:	zoledronate-fract-65-85yr
National Competent Authority:	Sweden - MPA
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2020-12-07
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Sweden - MPA

A.2

EudraCT number

2019-004766-17

A.3

Full title of the trial

The Fragility Fracture Trial (FFT): A randomized, double-blind, placebo-controlled trial to investigate whether zoledronic acid prevents new fractures in older adults with a recent non-hip, non-vertebral fragility fracture

A.3.1

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

Effects of zoledronic acid after a fragility fracture

Zoledronate till patienter med fraktur-En randomiserad dubbel-blind studie

A.3.2

Name or abbreviated title of the trial where available

Fragility Fracture Trial (FFT)

A.4.1

Sponsor's protocol code number

zoledronate-fract-65-85yr

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	Region Uppsala
B.1.3.4	Country	Sweden
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	Swedish Research Council
B.4.2	Country	Sweden
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Region Uppsala
B.5.2	Functional name of contact point	Peter Nordström
B.5.3	Address:
B.5.3.1	Street Address	Klinisk geriatrik, ingång 40, Akademiska sjukhuset
B.5.3.2	Town/ city	Uppsala
B.5.3.3	Post code	751 85
B.5.3.4	Country	Sweden
B.5.4	Telephone number	0046708996599
B.5.6	E-mail	peter.nordstrom@umu.se

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	Aclasta 5 mg solution for infusion
D.2.1.1.2	Name of the Marketing Authorisation holder	Novartis Europharm Limited
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.3.4	Pharmaceutical form	Infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous drip use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ZOLEDRONIC ACID
D.3.9.1	CAS number	118072-93-8
D.3.9.4	EV Substance Code	SUB00176MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.05
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Infusion
D.8.4	Route of administration of the placebo	Intravenous drip use (Noncurrent)

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Non-hip, non-vertebral fragility fracture

Fragilitetsfraktur annat än kotfraktur eller höftfraktur

E.1.1.1

Medical condition in easily understood language

Fracture other than of the hip or spine that occurs after a fall from standing height or less

Fraktur (exklusive fraktur i rygg eller höft) som orsakas av ett fall från ståhöjd eller lägre

E.1.1.2

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

MedDRA Classification

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 investigate whether zoledronic acid reduces the risk of new clinical fractures, as compared with placebo, in older adults with a recent non-hip, non-vertebral fragility fracture

E.2.2

Secondary objectives of the trial

To investigate whether zoledronic acid, as compared with placebo:

1. has a greater effect in reducing the risk of new clinical fractures in women than in men
2. reduces the risk of cancer
3. reduces the risk of cardiovascular disease (stroke or myocardial infarction)
4. reduces the risk of death
5. reduces the risk of falling

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Willing and able to provide written informed consent
2. Ambulatory (i.e., able to walk without the assistance of another person; canes, walkers, and other assistive devices are permitted)
3. Community dwelling (i.e., living in own home or with friends or relatives)
4. Sustained a non-hip, non-vertebral fragility fracture in the past 2 years
5. Age ≥65 years at the time of fracture

E.4

Principal exclusion criteria

1. History of hip fracture or vertebral compression fracture
2. Undergone bone density scanning since the fragility fracture
3. Severe renal impairment (estimated glomerular filtration rate of <35 ml per minute per 1.73 m2 of body surface area)
4. Remaining life expectancy of <1 year, according the investigator’s judgement
5. Hypocalcemia/hypercalcemia (serum calcium <2.2 or >2.6 mmol/L)
6. Sarcoidosis (contraindication for vitamin D)
7. Previous use of bone-protective drug (e.g., bisphosphonate, teriparatide, denosumab, raloxifene, or strontium ranelate; calcium and vitamin D are acceptable)
8. Use of systemic glucocorticoids at a dose of ≥5 mg (prednisolone or equivalent) for ≥3 months in the past year
9. Malabsorption of calcium and/or vitamin D (e.g., due to gastric bypass)
10. Other medication or medical condition for which bone-protective therapy is indicated (e.g., bone metastases or use of aromatase inhibitor; osteoporosis is permitted)

E.5 End points

E.5.1

Primary end point(s)

Time to new clinical fracture

E.5.1.1

Timepoint(s) of evaluation of this end point

4 and 10 years

E.5.2

Secondary end point(s)

1. Time to first non-vertebral fracture
2. Time to first new non-hip, non-vertebral fracture
3. Time to first hip fracture
4. Time to first new forearm fracture
5. Time to first clinical vertebral fracture
6. Time to death
7. Time to first new cardiovascular event (stroke or myocardial infarction)
8. Time to first new cancer diagnosis, excluding non-melanoma skin cancer
9. Time to first fall from standing height or less not resulting in fracture

E.5.2.1

Timepoint(s) of evaluation of this end point

4 and 10 years

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

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

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

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)

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

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:

2900

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

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

2900

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)

Participants in the placebo group will not be offered zoledronic acid because of budget constraints and because treatment decisions should be based on individual assessments made according to local guidelines.

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

2021-06-30

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-06-03

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

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