osteoporosis MedDRA version: 8.1 Level: PT Classification code 10031282
Conditions
Interventions
Trade Name: Bonviva® 150 mg
Product Name: Bonviva® 150mg film-coated tablets
Pharmaceutical Form: Tablet
INN or Proposed INN: ibandronic acid
Concentration unit: MBq/mg megabecquerel(s)/milligram
Conc
Sponsors
Roche (Hungary) Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
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? 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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the impact of bone marker feedback (using serum CTX and communication of the results) on adherence to once monthly ibandronate in women with postmenopausal osteoporosis supported by PRP (patient relationship program);Secondary Objective: • To evaluate the satisfaction of treatment with monthly ibandronate for each study arm as well as the whole study population including analyses of different patient categories based on the baseline variables (age, previous osteoporosis treatment if any); • To evaluate patient satisfaction with regimen (drug treatment and physician handling); • To evaluate patient satisfaction with a method of assessment through biomarker quantification; • To evaluate physician satisfaction with a method of assessment through biomarker quantification; • To evaluate the effect of monthly ibandronate on suppression of bone turnover markers; • To evaluate the impact of adherence to monthly ibandronate on bonemarker response; • To assess the safety of monthly ibandronate; • To evaluate the impact of PRP on adherence to monthly ibandronate intake;Primary end point(s): Assessment of Adherence For the primary end point patients are defined as having more than 83% adherence to treatment if they took 5 of the 6 monthly ibandronate tablets within the -1 to +21 days of their osteoporosis treatment date each month. Patient adherence will be assessed by maintaining records of “drug dispensed” and “drug returned” on the CRF and patient self-report at visit 2 and final visit. A drug dispensing log will be maintained by the investigator. Patients will be instructed at the baseline visit and at visit 2 to save and return unused or partially used medication packages on visit 2 and final study visit respectively. | — |
Countries
Latvia, Slovenia
Outcome results
None listed