Physician-Pharmacist Collaboration for Osteoporotic Patient Follow-up

Osteoporosis Clinical Trial

— SIOUX  

Official title:

Assessment of the Follow-up of Osteoporotic Patients by a Physician-pharmacist Collaboration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02892188
• Other study ID #: 2013-01Obs-CHRMT
• Status: Completed
• Start date: January 2013
• Est. completion date: February 2019

Study information

• Verified date: December 2019
• Source: Centre Hospitalier Régional Metz-Thionville
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to evaluate the follow-up of the osteoporotic patient by a physician-pharmacist collaboration.

Description:

Treatments allow decreasing the personal fracture risk from 48% to 85% provided that the treatment period is continued at least 3 to 5 years and that hygienic and dietary measures are applied: optimization of the dietary calcium intakes (much more efficient and less dangerous than the medicinal intakes), preservation of a physical activity, fall prevention. The ability of bisphosphonate for decreasing significantly the number of fractures was proved, but the lack of lasting adhesion (persistence) and of flanking measures leads to believe their efficiency may be enhanced: the hip-fracture rate decreases from 2.1% for the non-adherents to 1,3% for the patients with observance, which represents a one-half reduction.

The cost of surgery for a femoral neck fracture is estimated at 8500 euros. So the prevention of only one femoral neck fracture entails a huge economy.

However, 50% of women stop their treatment before a year and the implementation of hygienic and dietary measures leads to a lifestyle change, and faces long time ingrained habits. Only 42% of patients continue their treatment after two years, and only 16% after three years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• older than 18 years old

• having an osteoporosis treatment

• following a Therapeutical Education for Patient

Exclusion Criteria:

• opposition for anonymised data gathering

Related Conditions & MeSH terms

• Osteoporosis

Locations

Country	Name	City	State
France	CHR Metz-Thionville	Metz Cedex 03

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Régional Metz-Thionville

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respect of treatment and of hygienic dietary measures by patients with a self-questionnaire per medical check	This assessment will be made at the end of the follow-up, after three years, but an intermediary assessment about those same criteria is planned at one and two years of the follow-up.	year 3
Secondary	Qualitative evaluation of the professional adhesion for the follow-up process once a year during the annual meeting	This assessment will be made at the end of the follow-up, after three years, but an intermediary assessment about those same criteria is planned at one and two years of the follow-up.	year 3
Secondary	Quantitative evaluation of it by the return rate of questionnaires	This assessment will be made at the end of the follow-up, after three years, but an intermediary assessment about those same criteria is planned at one and two years of the follow-up.	year 3