Status:
COMPLETED
Evaluation Of Missed Osteoporosis Diagnoses, And Preference Between Once Monthly Ibandronate And Once Weekly Alendronate
Lead Sponsor:
GlaxoSmithKline
Conditions:
Osteoporosis
Eligibility:
FEMALE
60+ years
Phase:
PHASE4
Brief Summary
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...
Detailed Description
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 Institu...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00327990
Start Date
April 1 2005
End Date
December 1 2006
Last Update
May 30 2017
Active Locations (38)
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1
GSK Investigational Site
Bennebroek, Netherlands, 2121 BB
2
GSK Investigational Site
Breda, Netherlands, 4834 AD
3
GSK Investigational Site
Damwoude, Netherlands, 9104 GJ
4
GSK Investigational Site
Driebergen-Rijsenburg, Netherlands, 3972 WG