Condition category
Musculoskeletal Diseases
Date applied
10/10/2012
Date assigned
27/11/2012
Last edited
13/07/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims:
Osteoporosis affects postmenopausal women and elderly men, and causes loss of bone mass and damage to the bone structure. This leads to an increased risk of fractures. Death after such fractures is more likely. Protelos® is a medicine, which was shown to reduce fracture rates in postmenopausal women. Currently it has been approved for treatment of osteoporosis in men. In study we aim to observe the treatment of osteoporosis with Protelos® in men and postmenopausal women, and see if this has an effect in regards to pain reduction and quality of life.

Who can participate?
Men and postmenopausal women with osteoporosis who have an increased risk of fractures.

What does the study involve?
All patients involved in the study will be treated with Protelos®. The participants will be asked to attend a follow up visit after 3 months. During this visit, a routine investigation will be carried out where information on osteoporosis, other diseases the participant may have and other medications they are taking and pain will be completed. The participants will also be asked to fill out a quality of life questionnaire at each visit.

What are the possible benefits and risks of participating?
The patients have no particular benefits or risks of participating in this study. The treatment given to the participants is part of their daily routine and free to withdraw from the study at any time without giving a particular reason.

Where is the study run from?
The study will be carried out by orthopedic surgeons across Germany.

When is the study starting and how long is it expected to run for?
The study started in October 2012 and is due to end in May 2013. Participants will be recruited until February 2013.

Who is funding the study?
Servier Deutschland, GmbH.

Who is the main contact?
Dr Peter Martinka
peter.martinka@de.netgrs.com

Trial website

Contact information

Type

Scientific

Primary contact

Prof Johann Diederich Ringe

ORCID ID

Contact details

Westdeutsches Osteoporose-Zentrum
Klinikum Leverkusen gGmbH
Dhünnberg 60
Leverkusen
51375
Germany
-
ringe@klinikum-lev.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

IC4-12911-102-DEU

Study information

Scientific title

Protelos® evaluation in the osteoporotic men and women under daily practice conditions. A multicentric prospective observational study

Acronym

PANTHEON

Study hypothesis

Effects of therapy with Protelos® (Strontium ranelate) on the pain perception and quality of life in men and postmenopausal women with osteoporosis under daily routine in an observational prospective multicentre trial carried out by orthopedic surgeons and general practitioners.

Ethics approval

Freiburg Ethics Commission International (FEKI), 10/09/2012

Study design

Observational prospective multicentre open-label study

Primary study design

Observational

Secondary study design

Non-randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

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

Condition

Osteoporosis

Intervention

Observational study to get information about therapy of osteoporosis with Protelos®; under daily routine practice by orthopedic surgeons and general practitioners.

The treatment decision must be made prior to study initiation. Treating physicians will confirm the diagnosis of osteoporosis at baseline. After the baseline visit, there is a final visit after approx. 3 months.

Intervention type

Drug

Phase

Not Applicable

Drug names

Protelos® (Strontium ranelate)

Primary outcome measures

1. Effects of Protelos® on the osteoporosis-related pain
2. Effects of Protelos® on quality of life assessed by EQ-5D
3. Effects of Protelos® on analgesics prescription
4. Information about how Protelos® SmPC and patient information are followed via standardised documentation
5. Analysis of general tolerability of Protelos® under routine conditions via standardised adverse reactions documentation and standardised documentation of therapy discontinuation
6. Analysis of unknown adverse drug reactions via standardised documentation

Secondary outcome measures

No secondary outcome measures

Overall trial start date

08/09/2012

Overall trial end date

31/05/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adult men with osteoporosis at increased risk of fractures
2. Postmenopausal women with osteoporosis at increased risk of fractures

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

2960

Participant exclusion criteria

1. Does not meet inclusion criteria
2. In addition, doctors involved in the trial should follow the Summary of Product Characteristics (SmPC) for Protelos®, which includes the following contraindications:
2.1 Hypersensitivity to the active substance or to any of the excipients.
2.2 Current or previous venous thromboembolic events (VTE), including deep vein thrombosis and pulmonary embolism.
2.3 Temporary or permanent immobilisation due to e.g. post-surgical recovery or prolonged bed rest.

Recruitment start date

08/09/2012

Recruitment end date

01/02/2013

Locations

Countries of recruitment

Germany

Trial participating centre

Westdeutsches Osteoporose-Zentrum
Leverkusen
51375
Germany

Sponsor information

Organisation

Servier Deutschland GmbH (Germany)

Sponsor details

c/o Dr. Peter Martinka
Medical Affairs Officer
Elsenheimerstraße 53
München
80687
Germany
+49 (0)89 5709501
peter.martinka@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