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NCT Number: NCT00148915

A Study To Assess the Quality and Strength of Bone in Women Participants With Osteoporosis Taking Oral Ibandronate Versus Placebo

The purpose of this randomized, double-blind, placebo-controlled study is to estimate the effect of oral ibandronate sodium (Boniva) taken once monthly versus placebo on bone quality and strength at the proximal femur 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 between the age of 55 to 80 years diagnosed with osteoporosis
  • BMD T-Score less than or equal to (<=) -2.0 at total spine or total femur or total neck, and BMD T-score greater than or equal to (>=) -5.0 at all 3 sites

Exclusion criteria

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

Treatment and study plan

Ibandronate

Drug

Other names: Boniva

Placebo

Drug

matching placebo

Primary outcomes

  1. Mean percent change in integral (cortical and trabecular bone compartments combined) hip bone mineral density (BMD) as determined by Volumetric Quantitative Computed Tomography (vQCT) at one year

    Time frame: Year 1

Secondary outcomes

  1. Mean percent change in BMD of the proximal femur and lumbar spine according to vQCT at one year

    Time frame: Year 1

  2. Mean percent change of proximal femur and spine BMD according to Dual- Energy X-ray Absorptiometry (DXA) scans

    Time frame: Year 1

  3. Hip geometry assessed by cross-sectional dimensions of hip using vQCT

    Time frame: Year 1

  4. Finite element composition of hip and spine to estimate hip and spine strength

    Time frame: Year 1

  5. Hip geometry assessed by cross-sectional dimensions of hip using DXA

    Time frame: Year 1

  6. Trabecular bone dimensions by bone biopsies using histomorphometry and micro computed tomography to assess bone quality

    Time frame: Year 1

  7. Change from baseline for serum-C-terminal cross-linking telopeptide of Type I collagen (Serum-CTX)

    Time frame: Months 3, 6, 9, and 12

  8. Change from baseline for bone-specific alkaline phosphatase (Bone ALP)

    Time frame: Months 3, 6, 9, and 12

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A One Year, Parallel, Placebo-controlled, Double-blind, Randomized Study to Assess the Effect of Monthly 150 mg 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
Sep 8, 2005
Registry last updated
Nov 8, 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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