Open label, parallel group, multicenter study of two IV ibandronate regimens (2 mg every 2 months and 3 mg every 3 months) in women with postmenopausal osteoporosis who completed trial BM16550.

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 650

Inclusion Criteria

•Patients who completed the 2 year treatment period in study BM16550 and who had a 75% or more compliance to the IV regimen during the last year of the study; i.e., missed no more than one IV injection during the second year of study BM16550;
•Patients with at least 2 evaluable (L2-L4) vertebrae present on the 2 year lumbar spine BMD scan in study BM165501;
•Patients must be ambulatory at the beginning of the trial. It must not be anticipated that the patient becomes hospitalized, immobilized, or bedridden during the course of the trial;
•Patients who, in the opinion of the investigator, are able and willing to comply with the protocol for its duration;
•Patients who have provided written informed consent to participate in the study.
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

•Patients who completed the 2 year treatment period in study BM16550 more than 3 months prior to the planned baseline visit for study MA17904;
•Severe renal failure (2calculated GFR < 30 ml/min.);
•Malignant disease diagnosed since inclusion into study BM16550 (except successfully resected basal cell cancer);
•Disease/disorder known to influence bone metabolism: Chronic gastrointestinal or liver disease, chronic alcoholism, severe malabsorption syndrome, primary hyperparathyroidism (patients with surgically treated hyperparathyroidism with documented normal serum calcium and PTH will be eligible for enrollment), Paget's disease of bone, histologically documented osteomalacia, or documented active thyroid disease without treatment;
•Administration of any investigational drug other than ibandronate within 30 days preceding the first dose of the study drug;
•Treatment with drugs affecting bone metabolism since the inclusion of the patient into study BM16550, including:
oFluoride (dose greater than 10 mg/day);
oStrontium;
oPTH or similar anabolic agent;
oSystemic hormones (e.g. estrogens3, progestins, SERMs, anabolic steroids, active Vitamin D analogs/metabolites, calcitonin);
oCalcineurin inhibitors [e.g. cyclosporine, tacrolimus]4 or methotrexate;
oTreatment with any bisphosphonate other than ibandronate.
•Treatment with chronic systemic corticosteroid5 at doses affecting bone metabolism within the last 6 months.

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

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