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

Condition(s) targeted: Osteoporosis

Intervention: Ibandronate (Drug); Alendronate (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline

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.

Official title: 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).

Study design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study

Primary outcome: 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 outcome: 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.

Minimum age: 60 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

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.

GSK Clinical Trials Call Center, TILBURG 5038 DE, Netherlands

GSK Clinical Trials Call Center, LOSSER 7581 BV, Netherlands

GSK Clinical Trials Call Center, EERSEL 5521 CD, Netherlands

GSK Clinical Trials Call Center, HEERLEN 6417 BR, Netherlands

GSK Clinical Trials Call Center, POORTVLIET 4693 BT, Netherlands

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GSK Clinical Trials Call Center, HOOGWOUD 1718 BG, Netherlands

GSK Clinical Trials Call Center, ZAANDAM 1504 JA, Netherlands

GSK Clinical Trials Call Center, HEERLEN 6415 HT, Netherlands

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Starting date: April 2005
Last updated: November 8, 2007