Clinical trial NCT02157753: Quality of the Detection & Treatment of Osteoporotic Fractures in a Swiss Trauma Center
Official title: Osteoporotic Fractures in a Swiss Trauma Center - Observational Study to Improve the Diagnosis and Management of and the Persistence to Therapy.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporosis, Postmenopausal
Osteoporosis
Keywords: Osteoporotic fracture
treatment for osteoporosis
adherence and compliance
Lead sponsor: Kantonsspital Aarau
Sponsor class: OTHER
First posted: 2014-06-06
Enrollment: 478
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Every patient with fracture over age of 49, admitted to the Kantonsspital Aarau and treated by the traumatology department, whom a treatment for osteoporosis was suggested according to national guidelines

Brief summary: As a tertiary hospital the Traumatology department at the Kantonsspital Aarau looks after about 500 fracture patients hospitalized with an age over 50 years a year. First, we were interested in the effective rate of osteoporotic fractures in this cohort. As to this objective we offered subsequent diagnostics in suspected patients. 2012 we introduced a diagnostic pathway for every patient over 50 years of age with a fracture, including dual energy x-ray absorptiometry (DXA), a questionnaire about risk factors concerning osteoporosis and risk of fracture, the WHO Fracture Risk Assessment Tool (FRAX) and a laboratory workup focusing on this topic. Considering all these information we sent a detailed therapy-plan to the responsible General practitioner.

The main goal of this study is to verify the persistence and compliance of the osteoporosis therapy 12-15 months after fracture and to clarify any obstacles potentially impeding therapy (prejudice, adverse events, contraindication overlooked, financial problems etc.). The investigators use a postal questionnaire provided to the patient and the general practitioner. Data collection is undertaken by a study nurse, in addition phoning for missing data by phone-call. With the aim to ameliorate the implementation of treatment, patients and general practitioners will be provided with the specifically tailored information found to be missing.


Eligibility criteria: Inclusion criteria:

* age over 50 years
* any peripheral fracture, which led to hospitalisation in Kantonsspital Aarau, traumatology department

Exclusion Criteria:

* no informed consent
* age under 50 years
* not treated by traumatology department

Primary outcomes:
measure: Persistence and compliance with treatment for osteoporosis
timeFrame: 12-15 month after initial fracture
Secondary outcomes:
Other outcomes:
Locations:
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau
Study officials:
affiliation: Kantonsspital Aarau
name: Thomas Gross, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: Kantonsspital Aarau
name: Christoph Hemmeler, Dr.med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Morell S, Hemmeler C, Amsler F, Gross T. Adherence to osteoporosis pharmacotherapy one year after osteoporotic fracture - a Swiss trauma center secondary prevention project. Swiss Med Wkly. 2017 Jul 10;147:w14451. doi: 10.4414/smw.2017.14451. eCollection 2017.
citation: Hemmeler C, Morell S, Amsler F, Gross T. Screening for osteoporosis following non-vertebral fractures in patients aged 50 and older independently of gender or level of trauma energy-a Swiss trauma center approach. Arch Osteoporos. 2017 Dec;12(1):38. doi: 10.1007/s11657-017-0334-3. Epub 2017 Apr 8.