Quality of the Detection & Treatment of Osteoporotic Fractures in a Swiss Trauma Center

Osteoporosis Clinical Trial

Official title:

Osteoporotic Fractures in a Swiss Trauma Center - Observational Study to Improve the Diagnosis and Management of and the Persistence to Therapy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02157753
• Other study ID #: 2013/036
• Status: Completed
• Phase: N/A
• First received: June 3, 2014
• Last updated: March 5, 2018
• Start date: July 2012
• Est. completion date: December 2015

Study information

• Verified date: March 2018
• Source: Kantonsspital Aarau
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 478
• Est. completion date: December 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal
• Osteoporotic Fractures

Locations

Country	Name	City	State
Switzerland	Kantonsspital Aarau	Aarau

Sponsors (1)

Lead Sponsor	Collaborator
Kantonsspital Aarau

Country where clinical trial is conducted

Switzerland, 

References & Publications (2)

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: — View 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 11;147:w14451. doi: 10.4414/smw.2017.14451. eCollection — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Persistence and compliance with treatment for osteoporosis	percentage of persons receiving prescription vs. following completely / partially treatment advice; both, according to self declaration vs. general practitioner information; collection of arguments if therapy was not undertaken	12-15 month after initial fracture