Osteoporosis, Postmenopausal, Osteoporosis, Steroid Induced
Conditions
Keywords
osteoporosis, quality of life, adherence, treatment
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).
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
Interventions
DRUGTeriparatide
The study will include patients from pre-defined groups of individuals (postmenopausal, male, and steroid-induced osteoporosis) who would any way receive teriparatide for their condition according to standard medical practice and Greek treatment guidelines
Sponsors
Hellenic Osteoporosis Foundation (www.http://heliost.gr/en/)
251 Hellenic Air Force & VA General Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Greece
Outcome results
None listed