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OpenTrials
Completed

NCT Number: NCT00545207

A Study of Bonviva (Ibandronate) Once Monthly in Post-Menopausal Women With Osteopenia.

This 2 arm study will compare the effect of oral Bonviva (150mg, monthly) and placebo on parameters of bone micro-architecture, assessed by CT scan, bone turnover and bone mineral density. Patients will be randomized to receive either Bonviva 150mg po or placebo monthly, and measurements will be taken at baseline, and at intervals over 2 years. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals.

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Key information

Conditions

Post-Menopausal Osteopenia

Age range

55 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Lyon, France

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • post-menopausal women, aged 55-75 years;
  • diagnosed osteopenia.

Exclusion criteria

  • history of osteoporotic vertebral fracture;
  • contraindication to ibandronate.

Treatment and study plan

ibandronate [Bonviva/Boniva]

Drug

150mg po monthly for 2 years

Placebo

Drug

po monthly for 2 years

Primary outcomes

  1. Trabecular BV/TV at distal radius of non-dominant arm

    Time frame: 12 arms

Secondary outcomes

  1. Trabecular BV/TV at distal radius of non-dominant arm

    Time frame: 6 months and 2 years

  2. Bone density, trabecular BV/TV at distal tibia

    Time frame: 6 months, 1 and 2 years

  3. Serum CTX

    Time frame: Intervals throughout study

  4. Lumbar hip and wrist BMD

    Time frame: 1 and 2 years

  5. AEs and laboratory parameters

    Time frame: Throughout study

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Randomized, Double-blind Study of the Effect of Oral Monthly Bonviva on in Vivo Bone Micro-architecture Parameters in Post-menopausal Women With Osteopenia

Important dates

Primary completion
2010
Study completion
2010
First posted
Oct 17, 2007
Registry last updated
Jan 26, 2017

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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