Adherence to Osteoporosis Treatment and Physicians' Perception Regarding Osteoporosis Medication (IASIS)

January 9, 2019 updated by: Dr Polyzois Makras, 251 Hellenic Air Force & VA General Hospital

Prospective,Non-interventional Study Investigating Possible Correlation Between Adherence to Postmenopausal and Steroid Induced Osteoporosis Treatment and Physicians' Perception Regarding Osteoporosis Medication

This is a study aiming to investigate a possible correlation between the parameters affecting the physicians' therapeutic choice with the patients' overall adherence to osteoporosis treatment. Secondary end-points include correlation between the parameters affecting the physicians' therapeutic choice and the patients' quality of life as well as the evaluation of the whole osteoporosis treatment approach of orthopedic surgeons in Greece (diagnostic means, use of diagnostic and treatment guidelines, methodology of follow - up).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will include 100 orthopedic surgeons from the private sector working in private offices. The selection of this group of physicians resides on the fact that orthopedic surgeons working in private offices hold more than 60% of osteoporosis prescriptions in Greece.

Each physician will fill once a questionnaire regarding the parameters affecting his/her choice of osteoporosis treatment before entering any patient in the study. Following the completion of the questionnaire every physician will recruit up to 10 patients in the study who are eligible for osteoanabolic treatment (teriparatide) according to standard medical practice and the Greek osteoporosis treatment guidelines.

Each patient will receive teriparatide up to 24 months while he/she will fill the Greek EQ5D questionnaire on months: 0,12,24 or at early discontinuation. Adherence to treatment will be evaluated at the same time points as well as on monthly telephone interviews.

Both the adherence to treatment and the possible alteration of patients' quality of life (evaluated through the EQ5D questionnaire) during the study will be correlated with the parameters affecting the initial therapeutic decision of the physician

Study Type

Observational

Enrollment (Actual)

851

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

  • Greece
    • Attiki
      • Athens, Attiki, Greece, 11525
        • 251 Hellenic Air Force & VA General Hospital

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

33 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Female patients with postmenopausal osteoporosis

Male patients ≥ 50 years old with idiopathic osteoporosis

Male and female patients with steroid-induced osteoporosis

Description

Inclusion Criteria:

  • Female patients with postmenopausal osteoporosis (T-score ≤-2,5 SD at any skeletal site) under osteoporosis treatment (except teriparatide) for at least one year with a history of ≥ low-energy fracture during the last 10 years prior the study.
  • Male patients ≥ 50 years old with idiopathic osteoporosis (T-score ≤-2,5 SD at any skeletal site) under osteoporosis treatment (except teriparatide) for at least one year with a history of ≥ low-energy fracture during the last 10 years prior the study.
  • Male and female patients with steroid-induced osteoporosis (T-score ≤-2,5 SD at any skeletal site) under osteoporosis treatment (except teriparatide) for at least one year with a history of ≥ low-energy fracture during the last 10 years prior the study.

Exclusion Criteria:

  • Prior use of teriparatide or PTH(1-84)
  • Hypersensitivity to teriparatide regimen.
  • Pregnancy and lactation.
  • Hypercalcamia.
  • Renal deficiency (eGFR < 30 ml/min).
  • Other bone metabolic diseases (including hyperparathyroidism and Paget's disease) except primary osteoporosis or steroid induced osteoporosis .
  • Uninterpretable increases of alkaline phosphatase (ALP)
  • Prior skeletal radiotherapy.
  • Skeletal malignancies or bone metastases

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to osteoporosis treatment assessed by medication possession ratio (MPR)
Time Frame: 2 years
Adherence to osteoporosis treatment assessed by medication possession ratio Adherence to osteoporosis treatment assessed by medication possession ratio (MPR) and correlation with the parameters affecting the physicians' therapeutic choices
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life assessed by EQ5D questionnaire
Time Frame: 2 years
Quality of life assessed by EQ5D questionnaire and correlation with the parameters affecting the physicians' therapeutic choice
2 years

Collaborators and Investigators

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

Sponsor

251 Hellenic Air Force & VA General Hospital

Collaborators

Hellenic Osteoporosis Foundation (www.http://heliost.gr/en/)

Investigators

  • Study Chair: George Lyritis, Professor, Hellenic Osteoporosis Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 1, 2015

Primary Completion (Actual)

June 30, 2018

Study Completion (Actual)

December 15, 2018

Study Registration Dates

First Submitted

June 10, 2015

First Submitted That Met QC Criteria

June 12, 2015

First Posted (Estimate)

June 16, 2015

Study Record Updates

Last Update Posted (Actual)

January 10, 2019

Last Update Submitted That Met QC Criteria

January 9, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 076/AD7592/S1684/6-5-2015

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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