Last updated: 11/04/2018 08:19:40
Evaluation Of Missed Osteoporosis Diagnoses, And Preference Between Once Monthly Ibandronate And Once Weekly Alendronate
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official 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)
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
300
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Osteoporosis
Product
ibandronic acid
Collaborators
Not applicable
Study date(s)
April 2005 to December 2006
Type
Interventional
Phase
4
Participation criteria
Sex
Female
Age
60+ years
Accepts healthy volunteers
No
- Women registered with a GP, without a prior history of osteoporosis. According to a case-finding procedure, osteoporosis will be diagnosed or excluded.
- 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.
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
DRIEBERGEN-RIJSENBURG, Netherlands, 3972 WG
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2006-27-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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