hPrevention of glucocorticoid-induced osteoporosis in postmenopausal women diagnosing any inflammatory rheumatoid disease polymyalgia rheumatica
Conditions
Interventions
Trade Name: Bonviva 150 mg
Product Name: Ibandronate
Product Code: Ro 200-5450
Pharmaceutical Form: Film-coated tablet
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration
Sponsors
Roche Oy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Postmenopausal women 2. = 1 years from menopause 3.Age 50-85 4.Having diagnosis of any inflammatory rheumatoid disease including polymyalgia rheumatica 5.Receiving treatment with 5-15 mg/day of prednisone 6.Mean lumbar spine (L1-L4) BMD = -2.0 7.Treatment for rheumatic disease stable for 3 months before entering the study 8.Presumably 5-15 mg/day prednisone treatment for at least one year 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
Exclusion criteria: 1.Clinical osteoporotic fractures 2.Femoral neck BMD 2.6 or < 2.0 mmol/l 9.Renal impairment defined by creatinine clearance <30 ml/min (calculated) 10.Administration of any investigational drug within 30 days preceding the first dose of study drug 11.Previous treatment with an oral bisphosphonate within the last 6 months, more than 1 month of treatment within the last year, more than 3 months of treatment within the last two years 12.Previous treatment with an IV bisphosphonate at any time 13.Treatment with PTH in the past 2 years 14.Treatment with other drugs affecting bone metabolism within the last 6 months e.g., estrogens (except for vaginal administration), progestins, selective estrogen receptor modulators (SERMs), calcineurin inhibitors, anabolic steroids/androgens, active vitamin D analogs/metabolites (alfacalcidol, calcitriol), calcitonin 15.Active disease/disorder known to influence bone metabolism, such as untreated or uncontrolled hyperthyroidism, hyperparathyroidism, osteomalacia, liver disease, chronic alcoholism or severe malabsorption syndrome 16.Malignant disease (except resected basal cell cancer and treated cervic carcinoma in situ) 17.untreated celiac disease 18.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, and - 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 investigate the efficacy and safety of once monthly ibandronate (150 mg po) plus vitamin D and calcium supplementation in the prevention of glucocorticoid-induced osteoporosis in postmenopausal women compared to oral placebo plus vitamin D and calcium supplementation;Secondary Objective: ;Primary end point(s): 1. Change (%) from baseline in mean lumbar spine (L1-L4) BMD at 12 months | — |
Countries
Finland
Outcome results
None listed