Mid Term Review Meeting 04042005

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Mid Term Review Meeting 04/04/2005
ADOQ Advanced Detection of Bone Quality
Overview of the project progress

• A. Berthier

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Project Objectives (1)
Project of the 5th FP of the European
Commission Funding EC, ESA, Swiss funding,
partners / Duration 42 months, started on
01/01/2003

• Objective validation of the 3DpQCT developed by
  SCANCO
• To demonstrate the contribution of bone structure
  and bone quality to assess the fracture risk and
  the evolution of osteoporosis
• To show the potential of the analysis of bone
  quality based on 3 Dimensional peripheral
  Computed Tomography (3DpQCT) for a better
  prevention of the risks, for an earlier detection
  and for a better monitoring of bone loss.
• To allow this new technology to be used
  effectively in clinical diagnostic practice and
  to be compared to DEXA.

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Project Objectives (2)

• Objectives of the clinical studies 5 clinical
  centers (UK, CH, D, F)
• To collect reference data on a general population
  aged from 18 on a population representative of
  astronauts,
• To evaluate the effects of different types of
  physical exercise on bone architecture as a
  prevention mean in young people,
• To assess the effects of a lack of physical
  activity on bone structure,
• To identify thresholds based on architectural
  parameters and densitometric parameters to better
  detect patients at higher risk of osteoporosis or
  at higher risk of fracture.

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Partnership
EUROPEAN SPACE AGENCY (ESA - ESTEC), Noordwijk,
The Netherlands Dr. R. Binot
FREE UNIV. BERLIN Berlin, Germany Dr. G.
Armbrecht Pr. Dieter Felsenberg M. Backström
CAMBRIDGE UNIV. Cambridge, UK Pr. J. Reeve N.
Dalzell
IBT-ETH Zürich, Switzerland Pr. P. Rügsegger Pr.
P. Niederer
ST ETIENNE UNIV. / INSERM St Etienne, France Pr.
C. Alexandre M. Zouch
SCANCO Zürich, Switzerland Dr. B. Koller
MEDES Toulouse, France L. Braak Dr. S. Beroud A.
Berthier
GENEVA UNIV. HOSPITALS Geneva, Switzerland Pr. R.
Rizzoli
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Planning at the KOM
2004
2005
2006
2003
01 04 07 10 01 04 07 10 01 04 07 10 01 03
Scientific report and cost statements
Final report cost statements
Development of the devices certification
eCRF
Files for Ethics committees
Cambridge
St Etienne
Geneva
Berlin
ESA/MEDES protocol
CPK / EDOS experiment
TBD Bed rest study
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Progress Planning after year 1 (01/2004)
2004
2005
2006
2003
01 04 07 10 01 04 07 10 01 04 07 10 01 03
Scientific report and cost statements
Final report cost statements
Development of the devices certification
eCRF
Files for Ethics committees
Cambridge
St Etienne
Geneva
Berlin
ESA/MEDES protocol
CPK / EDOS experiment
TBD Bed rest study
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Progress Planning after year 2 (01/2005)
2004
2005
2006
2003
01 04 07 10 01 04 07 10 01 04 07 10 01 03
Scientific report and cost statements
Final report cost statements
Development of the devices certification
eCRF
Files for Ethics committees radiation protection
Cambridge
St Etienne
Geneva
Berlin
ESA/MEDES protocol
CPK / EDOS experiment
Bed rest study
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Main issues / delays

• Year 2003
• Delay and review of the funding of EFOS for the
  Swiss partners
• For SCANCO, contract only signed in December 2003
  !
• Delay in the development of the systems,
  initiated first thanks to ESA co-funding and
  SCANCO own funding.
• Expected delay of 6 months in the deliveries at
  the end of 2003
• Year 2004
• Delay in CE certification
• Audit in March but certification only granted in
  July !
• 2 deliveries in August/september, 1 in October, 1
  delayed beginning of 2005 for other logistic
  reasons.
• Total delay of about 1 year in the deliveries

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Consequences for the planning

• Delays for some partners for the submission to
  the ethics committees (when it required
  additional measurements on-site).
• Beginning of the clinical studies
• St Etienne September 2004 instead of the fall of
  2003
• CAMB October 2004 instead of the fall of 2003
• BERLIN March 2005 (delay of the answer of BfS)
  instead of January 2004
• GENEVA March 2005 instead of January 2004.

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Two additional opportunities

• Participation to the long term bed rest study on
  women.
• Dedicated XtremeCT rented by ESA for 2 years
• This machine can be used as well for the ADOQ
  protocol to be performed in MEDES (instead of
  retrieving one machine from the partners 6 months
  before the project completion)
• EDOS experiment
• Pre and post flight measurements on astronauts
• Dedicated XtremeCT (resulting from negotiations
  between ESA/ SCANCO and the partners for
  purchasing the other XtremeCT after the project
  completion)
• No need to retrieve an XtremeCT of a partner at
  the end of the project
• ESA/SCANCO agreement
• 1 system dedicated for the bed rest and 1 for
  EDOS.
• All partners will be able to buy their XtremeCT
  after the project completion under the same
  conditions (110 000 )

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Consequences in terms of subject recruitment

• Original objectives of recruitment

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Consequences in terms of subject recruitment

• Expected recruitment up to 12/2005

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Consequences in terms of subject recruitment

• Expected recruitment up to 06/2006

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Funding

• Budget for the clinical studies

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Extension of duration

• Extension of 6 months requested
• To achieve the original objectives in terms of
  recruitment
• To include the 1st results of EDOS and of the bed
  rest study
• To have sufficient time to analyze the results in
  the team and to start disseminating the results
  in symposiums and through publications.
• Extension of contracts for the personnel
• For one partner, the contract of the personnel
  responsible for the measurements started as
  planned at the beginning and an extension will be
  necessary.
• This partner will look for other sources of
  funding
• If not solved, the study will have to stop end
  2005 in this centre.

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Coordination tools

• Web sites
• Public web site http//www.medes.fr/adoq
• Private web site http//www.medes.fr/privateadoq
  (restricted access)
• Documents of the project
• Documents on each protocol file submitted to
  ethics committee, questionnaires
• Common documents minutes, reports
• News
• Case report form application
• To centralise the results
• Results of questionnaires
• Results of the exams (parameters not images)
• Restricted access
• 2 logins passwords per center one for the
  operators, one for the WP leaders for the
  validation of all the data of his WP.
• Better communication within the partners
• Tool for progress monitoring

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Case report form application
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Case report form application

• 2003 - Specifications
• Definition of the different questionnaires with
  the partners
• Specifications of the scenarios
• 2004 - Development
• Delivery in May 2004
• Partners started using the application in
  September.
• Updates
• Automatic import of the XtremeCT results
• Implementation of an import function for the DEXA
  data

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Dissemination activities

• SCANCO - Commercialization of the XtremeCT
• Started in September 2004
• 5 systems sold outside ADOQ (2 in Europe, 3 in
  North America)
• Submission to FDA approval planned in 2005
• The device raises a lot of interest
• Detailed brochures in preparation
• Dissemination through the clinical centers
• Several contacts with pharmaceutical companies
  interested in the XtremeCT.
• Dissemination of the scientific results
• Participation in MEDICA in 11/2004 on ESA booth.
• Participations to symposiums planned in 2006
• World congress of biomechanics.
• IOF meeting
• Others

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Planning for the coming months

• Performance of the clinical studies
• Finite element analyses
• First reporting on the results at the end of 2005
• Dissemination activities
• Through SCANCO for the commercialization
• Through the clinical research network
• 1st publications.
• Looking for interesting research studies in
  continuation to ADOQ in answer to EC calls or/and
  with pharmaceutical companies.