PERSPECTIVES: Protelos® for postmenauposal osteoporotic patients with previous therapies
| ISRCTN | ISRCTN80637249 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN80637249 |
| Secondary identifying numbers | IC4-12911-101-DEU |
- Submission date
- 20/02/2009
- Registration date
- 15/05/2009
- Last edited
- 23/01/2019
- 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
Dr Martin Kühn
Scientific
Scientific
Servier Deutschland GmbH
Elsenheimer Str. 53
Munich
80687
Germany
| Phone | +49 89 57095308 |
|---|---|
| martin.kuehn@de.netgrs.com |
Study information
| Study design | Observational prospective longitudinal multi-centre study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Multi-centre |
| Study setting(s) | Not specified |
| 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 | PERSPECTIVES: Protelos® for postmenauposal osteoporotic patients with previous therapies - an observational prospective multi-centre study |
| Study acronym | PERSPECTIVES |
| Study objectives | Effects of Protelos® therapy on osteoporosis and osteoporosis symptoms under practice daily routine in a non-interventional trial. |
| Ethics approval(s) | Ethics Committee of Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin), Campus Benjamin Franklin, approved on 08/01/2009 (ref: EA4/101/08) |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | 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 study start date | 02/02/2009 |
| Completion date | 30/09/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 2,250 patients/ max. 750 doctors |
| Key inclusion criteria | Postmenopausal osteoporotic women, treated with strontium ranelat (Protelos®). |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 02/02/2009 |
| Date of final enrolment | 30/09/2009 |
Locations
Countries of recruitment
- Germany
Study participating centre
Servier Deutschland GmbH
Munich
80687
Germany
80687
Germany
Sponsor information
Servier Deutschland GmbH (Germany)
Industry
Industry
Elsenheimer Str. 53
Munich
80687
Germany
| Phone | +49 89 5709501 |
|---|---|
| marie-laure.escafit-schuelke@de.netgrs.com | |
| Website | http://www.servier.de |
"ROR" |
https://ror.org/05wk4ae67 |
Funders
Funder type
Industry
Servier Deutschland GmbH (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2012 | Yes | No |
Editorial Notes
23/01/2019: Publication reference added.
