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

Osteoporosis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00327990
• Other study ID #: IBN104125
• Status: Completed
• Phase: Phase 4
• First received: May 18, 2006
• Last updated: May 24, 2017
• Start date: April 2005
• Est. completion date: December 2006

Study information

• Verified date: May 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• Ibandronate

• Alendronate

Locations

Country	Name	City	State
Netherlands	GSK Investigational Site	Bennebroek
Netherlands	GSK Investigational Site	Breda
Netherlands	GSK Investigational Site	Damwoude
Netherlands	GSK Investigational Site	Den Haag
Netherlands	GSK Investigational Site	Den Haag
Netherlands	GSK Investigational Site	Den Haag
Netherlands	GSK Investigational Site	Driebergen-rijsenburg
Netherlands	GSK Investigational Site	Easterein
Netherlands	GSK Investigational Site	Eersel
Netherlands	GSK Investigational Site	Eindhoven
Netherlands	GSK Investigational Site	Enschede
Netherlands	GSK Investigational Site	Etten-leur
Netherlands	GSK Investigational Site	Geleen
Netherlands	GSK Investigational Site	Groesbeek
Netherlands	GSK Investigational Site	Heerlen
Netherlands	GSK Investigational Site	Hengelo
Netherlands	GSK Investigational Site	Hoogvliet
Netherlands	GSK Investigational Site	Hoogwoud
Netherlands	GSK Investigational Site	Hulst
Netherlands	GSK Investigational Site	Landgraaf
Netherlands	GSK Investigational Site	Losser
Netherlands	GSK Investigational Site	Midwoud
Netherlands	GSK Investigational Site	Nijverdal
Netherlands	GSK Investigational Site	Nunspeet
Netherlands	GSK Investigational Site	Oldebroek
Netherlands	GSK Investigational Site	Oudenbosch
Netherlands	GSK Investigational Site	Poortvliet
Netherlands	GSK Investigational Site	Prinsenbeek
Netherlands	GSK Investigational Site	Raalte
Netherlands	GSK Investigational Site	Ridderkerk
Netherlands	GSK Investigational Site	Rotterdam
Netherlands	GSK Investigational Site	Spijkenisse
Netherlands	GSK Investigational Site	Tilburg
Netherlands	GSK Investigational Site	Voerendaal
Netherlands	GSK Investigational Site	Wassenaar
Netherlands	GSK Investigational Site	Wildervank
Netherlands	GSK Investigational Site	Woerden
Netherlands	GSK Investigational Site	Zaandam

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.