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

A One Year, Parallel, Placebo-controlled, Double-blind, Randomized Study to Assess the Effect of Monthly 150mg Oral Ibandronate Dosing Versus Placebo on Bone Quality and Strength at the Proximal Femur in Women With Osteoporosis

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02948881

Enrollment

100

Registered

2016-10-31

Start date

2005-08-31

Completion date

2007-07-31

Last updated

2016-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis

Keywords

Osteoporosis, bisphosphonates, bone

Brief summary

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.

Interventions

DRUGibandronate

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

FEMALE

Age

55 Years to 80 Years

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).

Design outcomes

Primary

Measure	Time frame
Bone quality and strength at the hip by characterizing changes in trabecular and cortical bone quality using Volumetric Quantitative Computed Tomography (vQCT) and novel imaging analysis methods, including a subset of bone biopsies for one year.	1 Year

Secondary

Measure	Time frame
Relationship between biomarkers and changes in bone quality for one year.	1 Year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026