Prospective,Non-interventional Study Investigating Possible Correlation Between Adherence to Postmenopausal and Steroid Induced Osteoporosis Treatment and Physicians' Perception Regarding Osteoporosis Medication
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 851
- 试验地点
- 1
- 主要终点
- Adherence to osteoporosis treatment assessed by medication possession ratio (MPR)
研究概览
简要总结
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).
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Adherence to osteoporosis treatment assessed by medication possession ratio (MPR)
时间窗: 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
次要结局
- Quality of life assessed by EQ5D questionnaire(2 years)
研究者
Dr Polyzois Makras
Deputy Director, Dpt of Endocrinology & Diabetes
251 Hellenic Air Force & VA General Hospital