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Completed

NCT Number: NCT02892188

Physician-Pharmacist Collaboration for Osteoporotic Patient Follow-up

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHR Metz-Thionville

Metz, 57085, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • opposition for anonymised data gathering

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional Metz-Thionville

Other

Registry information

Official study title

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

Acronym: SIOUX

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Sep 8, 2016
Registry last updated
Jan 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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