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
- Conditions
- osteoporosis in postmenopausal women
- Registration Number
- EUCTR2005-005399-34-AT
- Lead Sponsor
- .V. Roche S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 800
- 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method