IASIS: Adherence to Osteoporosis Treatment and Physicians' Perception Regarding Osteoporosis Medication

Sponsor

251 Hellenic Air Force & VA General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02472782

Collaborator

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

851

Enrollment

Location

43.5

Duration (Months)

19.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis, Postmenopausal Osteoporosis, Steroid Induced	Drug: Teriparatide

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 Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

851 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

May 1, 2015

Actual Primary Completion Date :

Jun 30, 2018

Actual Study Completion Date :

Dec 15, 2018

Outcome Measures

Primary Outcome Measures

Adherence to osteoporosis treatment assessed by medication possession ratio (MPR) [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

Secondary Outcome Measures

Quality of life assessed by EQ5D questionnaire [2 years]
Quality of life assessed by EQ5D questionnaire and correlation with the parameters affecting the physicians' therapeutic choice

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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