Physician-Pharmacist Collaboration for Osteoporotic Patient Follow-up (SIOUX)

December 31, 2019 updated by: Centre Hospitalier Régional Metz-Thionville

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

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

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Metz Cedex 03, France, 57085
        • CHR Metz-Thionville

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patient having osteoporosis enrolled into the programm of Therapeutical Educational for patient

Description

Inclusion Criteria:

  • older than 18 years old
  • having an osteoporosis treatment
  • following a Therapeutical Education for Patient

Exclusion Criteria:

  • opposition for anonymised data gathering

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respect of treatment and of hygienic dietary measures by patients with a self-questionnaire per medical check
Time Frame: year 3
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Qualitative evaluation of the professional adhesion for the follow-up process once a year during the annual meeting
Time Frame: year 3
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
Quantitative evaluation of it by the return rate of questionnaires
Time Frame: year 3
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Régional Metz-Thionville

Investigators

  • Principal Investigator: Didier POIVRET, MD, CHR Metz-Thionville

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2013

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

February 1, 2019

Study Registration Dates

First Submitted

August 26, 2016

First Submitted That Met QC Criteria

September 1, 2016

First Posted (Estimate)

September 8, 2016

Study Record Updates

Last Update Posted (Actual)

January 2, 2020

Last Update Submitted That Met QC Criteria

December 31, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-01Obs-CHRMT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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