A Study To Assess The Quality Of Bone In Patients Taking Oral Ibandronate Versus Placebo

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 4

Conditions: Osteoporosis

Treatments: Drug: ibandronate

Study type: Interventional

Funder types: Industry

Identifiers

NCT02948881

BON103593

Details and patient eligibility

About

The purpose of this study is to estimate the effect of oral Boniva (ibandronate sodium)taken once monthly versus placebo on bone quality and strength at the hip at one year.

Enrollment: 100 patients

Sex: Female

Ages: 55 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ambulatory, postmenopausal women who are diagnosed with osteoporosis.
• Must be able to stand or sit upright for at least 60 minutes and swallow a tablet whole.

Exclusion criteria

• Have been treated with other bisphosphonates or using chronic steroids within the past 6 months.
• Have a history of major upper GI diseases or have severe kidney dysfunction.
• Have a spine fracture (identified on x-ray).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind