Condition category
Musculoskeletal Diseases
Date applied
20/02/2009
Date assigned
15/05/2009
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

Dr Martin Kühn

ORCID ID

Contact details

Servier Deutschland GmbH
Elsenheimer Str. 53
Munich
80687
Germany
+49 89 57095308
martin.kuehn@de.netgrs.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

IC4-12911-101-DEU

Study information

Scientific title

PERSPECTIVES: Protelos® for postmenauposal osteoporotic patients with previous therapies - an observational prospective multi-centre study

Acronym

PERSPECTIVES

Study hypothesis

Effects of Protelos® therapy on osteoporosis and osteoporosis symptoms under practice daily routine in a non-interventional trial.

Ethics approval

Ethics Committee of Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin), Campus Benjamin Franklin, approved on 08/01/2009 (ref: EA4/101/08)

Study design

Observational prospective longitudinal multi-centre study

Primary study design

Observational

Secondary study design

Multi-centre

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Postmenopausal osteoporosis

Intervention

1. To get information on the evolution of osteoporosis therapy in the treatment postmenopausal osteoporosis via standardised documentation
2. To get information on comobidity and comedication in postmenopausal osteoporosis via standardised documentation.
3. Evaluation of osteoporose-associated pain via Visual Analogue Scale (VAS)
4. Recording of new osteoporose-associated fractures via standardised documentation
5. Evaluation of the efficacy under routine conditions and tolerability of Protelos via Ordinal Scale
6. Recording of the osteoporosis-comedications via standardised documentation
7. Analysis of the adverse drug reactions of Protelos via standardised adverse drug reactions documentation
8. A patients questionnaire (at initiation visit and at final visit) will provide information on:
8.1. Evaluation of the quality of life (patients questionnaire including 9 questions = ordinal scale)
8.2. Evaluation of the compliance, persistence and adherence with Protelos®
8.3. Evaluation of non-medical therapies of postmenopausal osteoporosis (standardised patients questionnaire)

Total duration of follow-up: 3 months

Intervention type

Drug

Phase

Phase IV

Drug names

Strontium ranelate (Protelos®)

Primary outcome measures

1. Efficacy under routine conditions: ordinal scale (very good, good, moderate, bad)
2. Tolerability: ordinal scale (very good, good, moderate, bad)
3. Pain (VAS; 0 = no pain - 10 = unbearable pain)
4. Fractures (standardized documentation)
5. Quality of life (patients questionnaire including 9 questions = ordinal scale)
6. Compliance, persistence, adherence (standardised patients questionnaire)

All data will be assessed at initiation visit and 3 months later at final visit.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

02/02/2009

Overall trial end date

30/09/2009

Reason abandoned

Eligibility

Participant inclusion criteria

Postmenopausal osteoporotic women, treated with strontium ranelat (Protelos®).

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

2,250 patients/ max. 750 doctors

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

02/02/2009

Recruitment end date

30/09/2009

Locations

Countries of recruitment

Germany

Trial participating centre

Servier Deutschland GmbH
Munich
80687
Germany

Sponsor information

Organisation

Servier Deutschland GmbH (Germany)

Sponsor details

Elsenheimer Str. 53
Munich
80687
Germany
+49 89 5709501
marie-laure.escafit-schuelke@de.netgrs.com

Sponsor type

Industry

Website

http://www.servier.de

Funders

Funder type

Industry

Funder name

Servier Deutschland GmbH (Germany)

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