A randomised, open-label, multi-national study to investigate the impact of bone marker feedback (at 2 months) on adherence to once monthly Ibandronate treatment for post-menopausal osteoporosis (PMO) - BEATRIS

.V. Roche S.A.0 个研究点目标入组 580 人开始时间: 2006年8月7日最近更新: 2012年3月19日

研究概览

暂无简介。

•- Ambulatory post-menopausal women aged 55-85 years eligible for bisphosphonate treatment or with documented osteoporosis as determined by the treating physician in accordance with local practice;
•- Patients who are either naïve to bisphosphonates or lapsed bisphosphonate users (last bisphosphonate intake > 6 months ago);
•- Patients who, in the opinion of the investigator, are able to understand and complete the questionnaires, are willing and able to comply with the protocol requirements;
•- Patients who have signed the informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•- Hypersensitivity to bisphosphonates;
•- Inability to stand or sit in an upright position for at least 60 minutes;
•- Inability to swallow a tablet whole;
•- Contraindications to calcium or vitamin D therapy;
•- Administration of any investigational drug within 30 days preceding the first dose of the study drug;
•- Uncorrected hypocalcemia or other disturbances of bone and mineral metabolism;
•- Administration of antiresorptive medication within the last 6 months (bisphosphonates, SERMs, calcitonin and hormone replacement therapy);
•- Active disease/ disorder known to influence bone metabolism; eg. liver disease, chronic alcoholism, severe malabsorption syndrome, documented active thyroid disease without treatment;
•- Renal impairment (creatinine clearance <30 mL/min);
•- History of major upper GI disease defined by:
•- Significant upper GI bleeding within the last year requiring hospitalization or
•transfusion;
•- Recurrent peptic ulcer disease documented by radiographic or endoscopic means;
•- Dyspepsia or gastroesophageal reflux that is uncontrolled by medication;
•- Abnormalities of the esophagus that delay esophageal emptying, such as
•stricture, achalasia , or dysmotility;
•- Active gastric/duodenal ulcers.

发起方

.V. Roche S.A.