DIVA Study - A Study of Different Regimens of Intravenous Administration of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis

Roche

Status and phase: Completed; Phase 3

Conditions: Post Menopausal Osteoporosis

Treatments: Drug: ibandronate [Bonviva/Boniva]

Study type: Interventional

Funder types: Industry

Identifiers

NCT00048074

BM16550

Details and patient eligibility

About

This study will assess the efficacy and safety of intravenous administration of Bonviva regimens in women with post-menopausal osteoporosis, compared to oral daily administration. Patients will also receive daily supplementation with vitamin D and calcium. The anticipated time of study treatment is 2+ years, and the target sample size is 500+ individuals.

Enrollment: 1,395 patients

Sex: Female

Ages: 55 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• women 55-80 years of age;
• post-menopausal for >=5 years;
• ambulatory.

Exclusion criteria

• malignant disease diagnosed within the previous 10 years (except basal cell cancer that has been successfully removed);
• breast cancer within the previous 20 years;
• allergy to bisphosphonates;
• previous treatment with an intravenous bisphosphonate at any time;
• previous treatment with an oral bisphosphonate within the last 6 months, >1 month of treatment within the last year, or >3 months of treatment within the last 2 years.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,395 participants in 3 patient groups

1

Experimental group

Description:

oral placebo daily and IV ibandronate 2 mg q 2 mo

Treatment:

Drug: ibandronate [Bonviva/Boniva]

Drug: ibandronate [Bonviva/Boniva]

Drug: ibandronate [Bonviva/Boniva]

2

Experimental group

Description:

oral ibandronate 2.5 mg daily and IV placebo q 2 mo and q 3 mo

Treatment:

Drug: ibandronate [Bonviva/Boniva]

Drug: ibandronate [Bonviva/Boniva]

Drug: ibandronate [Bonviva/Boniva]

3

Experimental group

Description:

oral placebo daily and IV ibandronate 3 mg q 3 mo

Treatment:

Drug: ibandronate [Bonviva/Boniva]

Drug: ibandronate [Bonviva/Boniva]

Drug: ibandronate [Bonviva/Boniva]