The efficacy and safety of 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

ISRCTN	ISRCTN49960746
DOI	https://doi.org/10.1186/ISRCTN49960746
EudraCT/CTIS number	2006-006086-16
Secondary identifying numbers	CL3-12911-032

Submission date: 18/10/2007
Registration date: 30/11/2007
Last edited: 28/03/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration and not expected to be available in the future

Contact information

Prof J.M. Kaufman
Scientific

U.Z GENT Polyclinique dEndocrinologie
De Pintelaan 185
Gent
9000
Belgium

Study information

Study design	Randomised, double-blind, 2 parallel group, placebo-controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study acronym	MALEO
Study objectives	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(s)	Ethics approval received from local medical ethics committee in Italy on 13/09/2007
Health condition(s) or problem(s) studied	Male osteoporosis
Intervention	Strontium ranelate versus placebo for two years.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Strontium ranelate
Primary outcome measure	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 study start date	15/10/2007
Completion date	28/02/2011

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Male
Target number of participants	221
Key inclusion criteria	1. Caucasian males of at least 65 years of age 2. Osteoporosis
Key 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
Date of first enrolment	15/10/2007
Date of final enrolment	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

Study participating centre

U.Z GENT Polyclinique dEndocrinologie

Gent
9000
Belgium

Sponsor information

Institut de Recherches Internationales Servier (France)
Industry

50 rue Carnot
Suresnes
92284
France

Website	http://www.servier.com/
"ROR"	https://ror.org/034e7c066

Funders

Funder type

Industry

Institut de Recherches Internationales Servier (France)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
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.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Basic results				No	No
Results article	results	01/02/2013		Yes	No

Editorial Notes

28/03/2018: Publication plan and IPD sharing statement amended.
24/01/2018: Publication plan and IPD sharing statement added.