Additional identifiers
EudraCT number
2006-006086-16
ClinicalTrials.gov number
Protocol/serial number
CL3-12911-032
Study information
Scientific title
The efficacy and safety of 2g strontium ranelate in the treatment of male osteoporosis.
A prospective multicentre, international, double-blind, placebo-controlled study with a treatment duration of 2 years and the main study analysis after 1 year. - MALEO
Acronym
MALEO
Study hypothesis
To demonstrate the efficacy over 1 year of strontium ranelate compared to placebo on lumbar Bone Mineral Density (BMD) in men with osteoporosis.
As of 01/03/2011 the anticipated end date for this trial has been updated from 15/10/2009 to 28/02/2011
Ethics approval
Ethics approval received from local medical ethics committee in Italy on 13/09/2007
Study design
Randomised, double-blind, 2 parallel group, placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Male osteoporosis
Intervention
Strontium ranelate versus placebo for two years.
Intervention type
Drug
Phase
Not Specified
Drug names
Strontium ranelate
Primary outcome measures
Bone Mineral Density (BMD) of the lumbar spine.
Primary and secondary outcomes will be measured every 6 months.
Secondary outcome measures
1. BMD at the hip
2. Biochemical bone markers
Primary and secondary outcomes will be measured every 6 months.
Overall trial start date
15/10/2007
Overall trial end date
28/02/2011
Reason abandoned
Eligibility
Participant inclusion criteria
1. Caucasian males of at least 65 years of age
2. Osteoporosis
Participant type
Patient
Age group
Senior
Gender
Male
Target number of participants
221
Participant exclusion criteria
1. BMD T-score less than -4.0
2. More than two prevalent mild and/or moderate osteoporotic vertebral fractures
3. Severe osteoporotic vertebral fractures
Recruitment start date
15/10/2007
Recruitment end date
28/02/2011
Locations
Countries of recruitment
Australia, Belgium, Canada, France, Germany, Hungary, Ireland, Italy, Netherlands, Poland, Russian Federation, South Africa, Spain, Sweden, United Kingdom
Trial participating centre
U.Z GENT Polyclinique dEndocrinologie
Gent
9000
Belgium
Sponsor information
Organisation
Institut de Recherches Internationales Servier (France)
Sponsor details
50 rue Carnot
Suresnes
92284
France
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Institut de Recherches Internationales Servier (France)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Summary results are published on https://clinicaltrials.servier.com.
For interventional Phase III studies ending after the 1st January 2014, the results are/will be published in scientific literature.
IPD sharing plan: The datasets generated during and/or analysed during the current study will be available upon request from https://clinicaltrials.servier.com if a Marketing Authorisation has been granted after 1st January 2014.
Intention to publish date
Participant level data
Available on request
Results - basic reporting
http://clinicaltrials.servier.com/wp-content/uploads/CL3-12911-032_synopsis_report_1.pdf
Publication summary
2013 results in https://www.ncbi.nlm.nih.gov/pubmed/23341486