Protelos® evAluation iN THe osteoporotic mEn and wOmen under daily practice conditioNs
| ISRCTN | ISRCTN73451388 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN73451388 |
| Secondary identifying numbers | IC4-12911-102-DEU |
- Submission date
- 10/10/2012
- Registration date
- 27/11/2012
- Last edited
- 22/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
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
Contact information
Scientific
Westdeutsches Osteoporose-Zentrum
Klinikum Leverkusen gGmbH
Dhünnberg 60
Leverkusen
51375
Germany
| ringe@klinikum-lev.de |
Study information
| Study design | Observational prospective multicentre open-label study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Non-randomised controlled trial |
| Study setting(s) | Other |
| 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 | Protelos® evaluation in the osteoporotic men and women under daily practice conditions. A multicentric prospective observational study |
| Study acronym | PANTHEON |
| Study objectives | 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(s) | Freiburg Ethics Commission International (FEKI), 10/09/2012 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Protelos® (Strontium ranelate) |
| Primary outcome measure | 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 study start date | 08/09/2012 |
| Completion date | 31/05/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 2960 |
| Key inclusion criteria | 1. Adult men with osteoporosis at increased risk of fractures 2. Postmenopausal women with osteoporosis at increased risk of fractures |
| Key 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. |
| Date of first enrolment | 08/09/2012 |
| Date of final enrolment | 01/02/2013 |
Locations
Countries of recruitment
- Germany
Study participating centre
51375
Germany
Sponsor information
Industry
c/o Dr. Peter Martinka
Medical Affairs Officer
Elsenheimerstraße 53
München
80687
Germany
| Phone | +49 (0)89 5709501 |
|---|---|
| peter.martinka@de.netgrs.com | |
| Website | http://www.servier.de |
"ROR" |
https://ror.org/05wk4ae67 |
Funders
Funder type
Industry
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? |
|---|---|---|---|---|---|
| Abstract results | results presented at DGRh | 17/09/2014 | No | No |
Editorial Notes
22/01/2019: Publication reference added.
