PERSPECTIVES: Protelos® for postmenauposal osteoporotic patients with previous therapies

ISRCTN	ISRCTN80637249
DOI	https://doi.org/10.1186/ISRCTN80637249
Protocol serial number	IC4-12911-101-DEU
Sponsor	Servier Deutschland GmbH (Germany)
Funder	Servier Deutschland GmbH (Germany)

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

Servier Deutschland GmbH
Elsenheimer Str. 53
Munich
80687
Germany

Phone	+49 89 57095308
Email	martin.kuehn@de.netgrs.com

Study information

Primary study design	Observational
Study design	Observational prospective longitudinal multi-centre study
Secondary study design	Multi-centre
Study type	Participant 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
Phase	Phase IV
Drug / device / biological / vaccine name(s)	Strontium ranelate (Protelos®)
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	30/09/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	2250
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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

23/01/2019: Publication reference added.