Condition category
Musculoskeletal Diseases
Date applied
18/10/2007
Date assigned
30/11/2007
Last edited
08/11/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof J.M. Kaufman

ORCID ID

Contact details

U.Z GENT Polyclinique d’Endocrinologie
De Pintelaan 185
Gent
9000
Belgium

Additional identifiers

EudraCT number

2006-006086-16

ClinicalTrials.gov number

Protocol/serial number

CL3-12911-032

Study information

Scientific title

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 d’Endocrinologie
Gent
9000
Belgium

Sponsor information

Organisation

Institut de Recherches Internationales Servier (France)

Sponsor details

50 rue Carnot
Suresnes
92284
France

Sponsor type

Industry

Website

http://www.servier.com/

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

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes