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

May 24, 2017 updated by: GlaxoSmithKline

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Bennebroek, Netherlands, 2121 BB
        • GSK Investigational Site
      • Breda, Netherlands, 4834 AD
        • GSK Investigational Site
      • Damwoude, Netherlands, 9104 GJ
        • GSK Investigational Site
      • Den Haag, Netherlands, 2582 LJ
        • GSK Investigational Site
      • Den Haag, Netherlands, 2544 KM
        • GSK Investigational Site
      • Den Haag, Netherlands, 2584 HV
        • GSK Investigational Site
      • Driebergen-rijsenburg, Netherlands, 3972 WG
        • GSK Investigational Site
      • Easterein, Netherlands, 8734 CG
        • GSK Investigational Site
      • Eersel, Netherlands, 5521 CD
        • GSK Investigational Site
      • Eindhoven, Netherlands, 5613 BE
        • GSK Investigational Site
      • Enschede, Netherlands, 7544 NZ
        • GSK Investigational Site
      • Etten-leur, Netherlands, 4872 LA
        • GSK Investigational Site
      • Geleen, Netherlands, 6163 GC
        • GSK Investigational Site
      • Groesbeek, Netherlands, 6561 CM
        • GSK Investigational Site
      • Heerlen, Netherlands, 6417 BR
        • GSK Investigational Site
      • Hengelo, Netherlands, 7255 AM
        • GSK Investigational Site
      • Hoogvliet, Netherlands, 3192 JN
        • GSK Investigational Site
      • Hoogwoud, Netherlands, 1718 BG
        • GSK Investigational Site
      • Hulst, Netherlands, 4561 CJ
        • GSK Investigational Site
      • Landgraaf, Netherlands, 6373 JS
        • GSK Investigational Site
      • Losser, Netherlands, 7581 BV
        • GSK Investigational Site
      • Midwoud, Netherlands, 1679 GJ
        • GSK Investigational Site
      • Nijverdal, Netherlands, 7442 LS
        • GSK Investigational Site
      • Nunspeet, Netherlands, 8071 LX
        • GSK Investigational Site
      • Oldebroek, Netherlands, 8096 AV
        • GSK Investigational Site
      • Oudenbosch, Netherlands, 4731 MA
        • GSK Investigational Site
      • Poortvliet, Netherlands, 4693 BT
        • GSK Investigational Site
      • Prinsenbeek, Netherlands, 4841 RR
        • GSK Investigational Site
      • Raalte, Netherlands, 8101 ZW
        • GSK Investigational Site
      • Ridderkerk, Netherlands, 2985 VG
        • GSK Investigational Site
      • Rotterdam, Netherlands, 3082 DC
        • GSK Investigational Site
      • Spijkenisse, Netherlands, 3207 NB
        • GSK Investigational Site
      • Tilburg, Netherlands, 5038 DE
        • GSK Investigational Site
      • Voerendaal, Netherlands, 6367 ED
        • GSK Investigational Site
      • Wassenaar, Netherlands, 2241 KE
        • GSK Investigational Site
      • Wildervank, Netherlands, 9648 BE
        • GSK Investigational Site
      • Woerden, Netherlands, 3443 GG
        • GSK Investigational Site
      • Zaandam, Netherlands, 1504 JA
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

May 18, 2006

First Submitted That Met QC Criteria

May 18, 2006

First Posted (Estimate)

May 19, 2006

Study Record Updates

Last Update Posted (Actual)

May 30, 2017

Last Update Submitted That Met QC Criteria

May 24, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IBN104125

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Osteoporosis

Clinical Trials on Alendronate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Dominican Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe