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OpenTrials
Completed

NCT Number: NCT00327990

Evaluation Of Missed Osteoporosis Diagnoses, And Preference Between Once Monthly Ibandronate And Once Weekly Alendronate

This is a two part study (screening and treatment). The first part (screening) is designed to evaluate the percentage of patients missed in diagnosing osteoporosis by general practitioners (GP's). The second part (treatment) is designed to determine the preference by patients for the once monthly ibandronate or the once weekly alendronate.

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Key information

Age range

60 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

GSK Investigational Site, Bennebroek, Netherlands

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About this study

A multi-centre, randomised, open-label, cross-over study to evaluate the percentage of false negative osteoporosis diagnoses using the standard case-finding procedure as described by the Dutch Institute for Health Care (CBO) and to determine the preference of adult osteoporosis patients between once monthly dosing of ibandronate (150 mg) and once weekly dosing of alendronate (70 mg).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Women registered with a GP, without a prior history of osteoporosis. According to a case-finding procedure, osteoporosis will be diagnosed or excluded.

Exclusion criteria

  • Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia.
  • Inability to stand or sit in the upright position for 60 minutes.
  • Previous use of bone active agents (e.g. strontium, PTH).
  • Significant medical condition which may preclude the patient's ability to complete the study.
  • History of alcohol or drug abuse.
  • Hypersensitivity to any component of the bisphosphonates alendronate and ibandronate.
  • Administration of any investigational drug within 30 days preceding the first dose of the study drug.
  • Serum total calcium > 10.5 mg/dL or < 8.0 mg/dL (equivalent to 2.63 mmol/L and 1.99 mmol/L).
  • Osteoporosis by secondary causes, will be excluded especially when an isolated deformity of the vertebral body is detected during x-ray analysis.

Treatment and study plan

Ibandronate

Drug

Alendronate

Drug

Other names: Ibandronate

Primary outcomes

  1. Part 1: Percentage of patients falsely not diagnosed with osteoporosis using the standard case-finding and additional X-ray procedure in GP practice. Part 2: Patient preference for once monthly ibandronate or once weekly alendronate

Secondary outcomes

  1. Part 1: To assess the safety and tolerance of both ibandronate and alendronate. Part 2: To assess patient preference in reminder methods during once monthly ibandronate regimen: postcard, text message or telephone patient relationship program.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Multi Centre, Randomised, Open Label, Cross-over Study to Evaluate the Percentage of False Negative Osteoporosis Diagnosis's Using the Standard Case-finding Procedure as Described by the Dutch Institute for Healthcare (CBO) and to Determine the Preference of Adult Osteoporosis Patients Between Once Monthly Dosing of Ibandronate (150 mg) and Once Weekly Dosing of Alendronate (70 mg)

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
May 19, 2006
Registry last updated
May 30, 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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