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

Roche

Status and phase: Completed; Phase 3

Conditions: Post-Menopausal Osteopenia

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00545207

ML19357

Details and patient eligibility

About

This 2 arm study will compare the effect of oral Bonviva (150mg, monthly) and placebo on parameters of bone micro-architecture, assessed by CT scan, bone turnover and bone mineral density. Patients will be randomized to receive either Bonviva 150mg po or placebo monthly, and measurements will be taken at baseline, and at intervals over 2 years. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals.

Enrollment: 150 patients

Sex: Female

Ages: 55 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• post-menopausal women, aged 55-75 years;
• diagnosed osteopenia.

Exclusion criteria

• history of osteoporotic vertebral fracture;
• contraindication to ibandronate.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: ibandronate [Bonviva/Boniva]

2

Placebo Comparator group

Treatment:

Drug: Placebo