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OpenTrials
Completed

NCT Number: NCT02948881

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

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.

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

55 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

GSK Investigational Site, Upland, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Ibandronate

Drug

Primary outcomes

  1. 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.

    Time frame: 1 Year

Secondary outcomes

  1. Relationship between biomarkers and changes in bone quality for one year.

    Time frame: 1 Year

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Oct 31, 2016
Registry last updated
Oct 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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