Clinical trial NCT00327990: Evaluation Of Missed Osteoporosis Diagnoses, And Preference Between Once Monthly Ibandronate And Once Weekly Alendronate
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoporosis
Keywords: ibandronate
osteoporosis
preference
case-finding
post-menopausal
alendronate
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-05-19
Enrollment: 300
Sex: FEMALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 second part (treatment) is designed to determine the preference by patients for the once monthly ibandronate or the once weekly alendronate.

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 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).

Eligibility 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.

Primary outcomes:
measure: 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:
measure: 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.
Other outcomes:
Locations:
city: Bennebroek
country: Netherlands
facility: GSK Investigational Site
city: Breda
country: Netherlands
facility: GSK Investigational Site
city: Damwoude
country: Netherlands
facility: GSK Investigational Site
city: Den Haag
country: Netherlands
facility: GSK Investigational Site
city: Den Haag
country: Netherlands
facility: GSK Investigational Site
city: Den Haag
country: Netherlands
facility: GSK Investigational Site
city: Driebergen-rijsenburg
country: Netherlands
facility: GSK Investigational Site
city: Easterein
country: Netherlands
facility: GSK Investigational Site
city: Eersel
country: Netherlands
facility: GSK Investigational Site
city: Eindhoven
country: Netherlands
facility: GSK Investigational Site
city: Enschede
country: Netherlands
facility: GSK Investigational Site
city: Etten-leur
country: Netherlands
facility: GSK Investigational Site
city: Geleen
country: Netherlands
facility: GSK Investigational Site
city: Groesbeek
country: Netherlands
facility: GSK Investigational Site
city: Heerlen
country: Netherlands
facility: GSK Investigational Site
city: Hengelo
country: Netherlands
facility: GSK Investigational Site
city: Hoogvliet
country: Netherlands
facility: GSK Investigational Site
city: Hoogwoud
country: Netherlands
facility: GSK Investigational Site
city: Hulst
country: Netherlands
facility: GSK Investigational Site
city: Landgraaf
country: Netherlands
facility: GSK Investigational Site
city: Losser
country: Netherlands
facility: GSK Investigational Site
city: Midwoud
country: Netherlands
facility: GSK Investigational Site
city: Nijverdal
country: Netherlands
facility: GSK Investigational Site
city: Nunspeet
country: Netherlands
facility: GSK Investigational Site
city: Oldebroek
country: Netherlands
facility: GSK Investigational Site
city: Oudenbosch
country: Netherlands
facility: GSK Investigational Site
city: Poortvliet
country: Netherlands
facility: GSK Investigational Site
city: Prinsenbeek
country: Netherlands
facility: GSK Investigational Site
city: Raalte
country: Netherlands
facility: GSK Investigational Site
city: Ridderkerk
country: Netherlands
facility: GSK Investigational Site
city: Rotterdam
country: Netherlands
facility: GSK Investigational Site
city: Spijkenisse
country: Netherlands
facility: GSK Investigational Site
city: Tilburg
country: Netherlands
facility: GSK Investigational Site
city: Voerendaal
country: Netherlands
facility: GSK Investigational Site
city: Wassenaar
country: Netherlands
facility: GSK Investigational Site
city: Wildervank
country: Netherlands
facility: GSK Investigational Site
city: Woerden
country: Netherlands
facility: GSK Investigational Site
city: Zaandam
country: Netherlands
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials, MD
role: STUDY_DIRECTOR
References: