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
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