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 |
| Clinical Trials Information System (CTIS) | 2006-006086-16 |
| Protocol serial number | CL3-12911-032 |
| Sponsor | Institut de Recherches Internationales Servier (France) |
| Funder | Institut de Recherches Internationales Servier (France) |
- 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
Scientific
U.Z GENT Polyclinique dEndocrinologie
De Pintelaan 185
Gent
9000
Belgium
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, double-blind, 2 parallel group, placebo-controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Strontium ranelate |
| Primary outcome measure(s) |
Bone Mineral Density (BMD) of the lumbar spine. |
| Key secondary outcome measure(s) |
1. BMD at the hip |
| Completion date | 28/02/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Male |
| Target sample size at registration | 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
- United Kingdom
- Australia
- Belgium
- Canada
- France
- Germany
- Hungary
- Ireland
- Italy
- Netherlands
- Poland
- Russian Federation
- South Africa
- Spain
- Sweden
Study participating centre
U.Z GENT Polyclinique dEndocrinologie
Gent
9000
Belgium
9000
Belgium
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| 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? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2013 | Yes | No | |
| Basic results | No | No | |||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
28/03/2018: Publication plan and IPD sharing statement amended.
24/01/2018: Publication plan and IPD sharing statement added.
