A Study of Bonviva (Ibandronate) Once Monthly in Post-Menopausal Women With Osteopenia

Roche

Status and phase: Completed; Phase 4

Conditions: Post-Menopausal Osteopenia

Treatments: Drug: ibandronate [Bonviva/Boniva]; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00129623

BA18492

Details and patient eligibility

About

This 2 arm study will evaluate the efficacy and safety of oral Bonviva 150mg once monthly compared with placebo in post-menopausal women with osteopenia. Patients will be randomized to receive either Bonviva 150mg po monthly, or placebo monthly. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.

Enrollment: 160 patients

Sex: Female

Ages: 45 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• women 45-60 years of age;
• post-menopausal;
• ambulatory.

Exclusion criteria

• vertebral fracture (except traumatic fracture such as in a motor vehicle accident);
• low-trauma osteoporotic fracture in any other bone;
• breast cancer diagnosed within last 20 years;
• other malignancy diagnosed within last 10 years, except successfully resected basal cell cancer;
• treatment with any bisphosphonate within last 2 years;
• treatment with other drugs affecting bone metabolism within last 6 months.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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160 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: ibandronate [Bonviva/Boniva]

2

Placebo Comparator group

Treatment:

Drug: Placebo