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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2012 results in: DOI: 10.1055 / s-0037-1621662