A randomised, open-label, multi-national, multi-center study to investigate the impact of bone-marker feedback (at 3 months) on adherence to once monthly ibandronate treatment of patients with post-menopausal osteoporosis (PMO) supported by PRP (patient relationship program). - BOUNCE

• Conditions: osteoporosis; MedDRA version: 8.1Level: PTClassification code 10031282

• Registration Number: EUCTR2005-005529-74-LV
• Lead Sponsor: Roche (Hungary) Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-23
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 626

Inclusion Criteria

• Ambulatory post-menopausal women aged 55-85 years eligible for bisphosphonate treatment, with documented osteoporosis as determined by the treating physician (menopausa is defined by having amenorrhea for at least one year prior to study entry OR by having previous ovariectomy);
• Patients who are either naive 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

Exclusion Criteria

• 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/hypercalcemia or other disturbances of bone and mineral metabolism;
• Antiresorptive medication within the last 6 months;
• Treatment with other drugs affecting bone metabolism;
• 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;
• Patients are not excluded because of previous or active gastrointestinal disease, except as outlined above (eg. symptoms of dyspepsia controlled by daily medication or prior history of non-recurrent peptic ulcer disease are not considered exclusionary)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified