Randomized, double-blind, double-dummy, parallel group, multicenter study to compare the efficacy and safety of once-monthly oral administration of 150 mg ibandronate with once-weekly oral administration of 70 mg alendronate in postmenopausal osteoporosis - Non-inferiority trial

Phase 1

• Conditions: Study in women with postmenopausal osteoporosis.

• Registration Number: EUCTR2004-002255-14-DK
• Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-10
• Last Update Posted: 3 October 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 1786

Inclusion Criteria

- Women, at least five years after menopause
- Age 55 to 84 years
- -5.0 SD =Mean lumbar spine BMD (L2-L4) T-score < -2.5 SD
- Written 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

- Inability to stand or sit upright for 60 mn
- Hypersensitivity to bisphosphonates and to any of their components
- Contra-indications for calcium or vitamin D therapy
- Vitamin D deficiency (serum 25-hydroxy vitamin D < 16ng/ml, equivalent to 40 nmol/l)
- Renal impairment (creatinine clearance< 35 mL/min, using Cockroft and gault equation)
- History of major upper GI disease
- Malignant disease diagnosed within the previous 10 years(except successfully resected basal cell cancer), breast cancer diagnosed within the previous 20 years
- Active disease/disorder known to influence bone metabolism
- Previous treatment with other drugs affecting bone metabolism

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate non-inferiority of lumbar spine and total hip BMD changes using once-monthly oral ibandronate 150 mg, versus once-weekly oral alendronate 70 mg and also to assess the tolerability and safety of ibandronate versus alendronate.;Secondary Objective: ;Primary end point(s): Relative change (%) from baseline in mean lumbar spine (L2-L4) BMD at 12 months.<br>Relative change (%) from baseline in total hip BMD at 12 months.