Open label, parallel group, multicenter study of two intravenious ibandronate regimens (2 mg every 2 months and 3 mg every 3 months) in women with postmenopausal osteoporosis who completed trial BM16550. - DIVA-LTE
- Conditions
- ong term study in women with postmenopausal osteoporosis.
- Registration Number
- EUCTR2004-002570-32-DE
- Lead Sponsor
- F. Hoffmann-La Roche Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 650
•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
•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 Main Objective: To study the tolerability and safety (including bone histomorphometry) of long-term treatment with intravenous ibandronate administered as 2 regimens, either 2 mg every 2 months or 3 mg every 3 months.;Secondary Objective: In addition, the study will assess effect of these regimens on lumbar spine and total hip BMD and markers of bone turnover.;Primary end point(s): To assess the long-term safety and tolerability of intravenous ibandronate therapy.<br>The safety of long-term IV ibandronate treatment will be assessed by means of adverse events, laboratory tests and bone histomorphometry.<br>Secondary endpoints:<br>To investigate lumbar spine and total hip BMD changes after long-term treatment with IV ibandronate and to investigate trough and peak serum CTX suppression at steady state. The primary efficacy variable is the relative change (%) from baseline at 36 months in mean lumbar spine (L2-L4) BMD.<br>
- Secondary Outcome Measures
Name Time Method