Overview

This trial is active, not recruiting.

Conditions osteoporosis, postmenopausal, osteoporosis, steroid induced
Treatment teriparatide
Sponsor 251 Hellenic Air Force & VA General Hospital
Collaborator Hellenic Osteoporosis Foundation (www.http://heliost.gr/en/)
Start date May 2015
End date June 2018
Trial size 1000 participants
Trial identifier NCT02472782, 076/AD7592/S1684/6-5-2015

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
Adherence to osteoporosis treatment assessed by medication possession ratio (MPR)
time frame: 2 years

Secondary Outcomes

Measure
Quality of life assessed by EQ5D questionnaire
time frame: 2 years

Eligibility Criteria

Male or female participants at least 35 years old.

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

Additional Information

Official title Prospective,Non-interventional Study Investigating Possible Correlation Between Adherence to Postmenopausal and Steroid Induced Osteoporosis Treatment and Physicians' Perception Regarding Osteoporosis Medication
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
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by 251 Hellenic Air Force & VA General Hospital.