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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2006-12-31

Brief Summary

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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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Detailed Description

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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).

Conditions

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Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Ibandronate

Intervention Type DRUG

Alendronate

Intervention Type DRUG

Other Intervention Names

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Ibandronate

Eligibility Criteria

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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.

Minimum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No