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

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Primary Purpose

Status

Completed

Phase

Phase 4

Locations

Netherlands

Study Type

Interventional

Intervention

Ibandronate

Alendronate

About this trial

This is an interventional treatment trial for Osteoporosis focused on measuring ibandronate, osteoporosis, preference, case-finding, post-menopausal, alendronate

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Outcomes

Primary Outcome Measures

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

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.

Full Information

NCT ID

NCT00327990

First Posted

May 18, 2006

Last Updated

May 24, 2017

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00327990

Brief Title

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

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

April 2005 (undefined)

Primary Completion Date

December 2006 (Actual)

Study Completion Date

December 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoporosis

Keywords

ibandronate, osteoporosis, preference, case-finding, post-menopausal, alendronate

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

300 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Ibandronate

Intervention Type

Drug

Intervention Name(s)

Alendronate

Other Intervention Name(s)

Ibandronate

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

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.

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

No

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials, MD

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Bennebroek

ZIP/Postal Code

2121 BB

Country

Netherlands

Facility Name

GSK Investigational Site

City

Breda

ZIP/Postal Code

4834 AD

Country

Netherlands

Facility Name

GSK Investigational Site

City

Damwoude

ZIP/Postal Code

9104 GJ

Country

Netherlands

Facility Name

GSK Investigational Site

City

Den Haag

ZIP/Postal Code

2544 KM

Country

Netherlands

Facility Name

GSK Investigational Site

City

Den Haag

ZIP/Postal Code

2582 LJ

Country

Netherlands

Facility Name

GSK Investigational Site

City

Den Haag

ZIP/Postal Code

2584 HV

Country

Netherlands

Facility Name

GSK Investigational Site

City

Driebergen-rijsenburg

ZIP/Postal Code

3972 WG

Country

Netherlands

Facility Name

GSK Investigational Site

City

Easterein

ZIP/Postal Code

8734 CG

Country

Netherlands

Facility Name

GSK Investigational Site

City

Eersel

ZIP/Postal Code

5521 CD

Country

Netherlands

Facility Name

GSK Investigational Site

City

Eindhoven

ZIP/Postal Code

5613 BE

Country

Netherlands

Facility Name

GSK Investigational Site

City

Enschede

ZIP/Postal Code

7544 NZ

Country

Netherlands

Facility Name

GSK Investigational Site

City

Etten-leur

ZIP/Postal Code

4872 LA

Country

Netherlands

Facility Name

GSK Investigational Site

City

Geleen

ZIP/Postal Code

6163 GC

Country

Netherlands

Facility Name

GSK Investigational Site

City

Groesbeek

ZIP/Postal Code

6561 CM

Country

Netherlands

Facility Name

GSK Investigational Site

City

Heerlen

ZIP/Postal Code

6417 BR

Country

Netherlands

Facility Name

GSK Investigational Site

City

Hengelo

ZIP/Postal Code

7255 AM

Country

Netherlands

Facility Name

GSK Investigational Site

City

Hoogvliet

ZIP/Postal Code

3192 JN

Country

Netherlands

Facility Name

GSK Investigational Site

City

Hoogwoud

ZIP/Postal Code

1718 BG

Country

Netherlands

Facility Name

GSK Investigational Site

City

Hulst

ZIP/Postal Code

4561 CJ

Country

Netherlands

Facility Name

GSK Investigational Site

City

Landgraaf

ZIP/Postal Code

6373 JS

Country

Netherlands

Facility Name

GSK Investigational Site

City

Losser

ZIP/Postal Code

7581 BV

Country

Netherlands

Facility Name

GSK Investigational Site

City

Midwoud

ZIP/Postal Code

1679 GJ

Country

Netherlands

Facility Name

GSK Investigational Site

City

Nijverdal

ZIP/Postal Code

7442 LS

Country

Netherlands

Facility Name

GSK Investigational Site

City

Nunspeet

ZIP/Postal Code

8071 LX

Country

Netherlands

Facility Name

GSK Investigational Site

City

Oldebroek

ZIP/Postal Code

8096 AV

Country

Netherlands

Facility Name

GSK Investigational Site

City

Oudenbosch

ZIP/Postal Code

4731 MA

Country

Netherlands

Facility Name

GSK Investigational Site

City

Poortvliet

ZIP/Postal Code

4693 BT

Country

Netherlands

Facility Name

GSK Investigational Site

City

Prinsenbeek

ZIP/Postal Code

4841 RR

Country

Netherlands

Facility Name

GSK Investigational Site

City

Raalte

ZIP/Postal Code

8101 ZW

Country

Netherlands

Facility Name

GSK Investigational Site

City

Ridderkerk

ZIP/Postal Code

2985 VG

Country

Netherlands

Facility Name

GSK Investigational Site

City

Rotterdam

ZIP/Postal Code

3082 DC

Country

Netherlands

Facility Name

GSK Investigational Site

City

Spijkenisse

ZIP/Postal Code

3207 NB

Country

Netherlands

Facility Name

GSK Investigational Site

City

Tilburg

ZIP/Postal Code

5038 DE

Country

Netherlands

Facility Name

GSK Investigational Site

City

Voerendaal

ZIP/Postal Code

6367 ED

Country

Netherlands

Facility Name

GSK Investigational Site

City

Wassenaar

ZIP/Postal Code

2241 KE

Country

Netherlands

Facility Name

GSK Investigational Site

City

Wildervank

ZIP/Postal Code

9648 BE

Country

Netherlands

Facility Name

GSK Investigational Site

City

Woerden

ZIP/Postal Code

3443 GG

Country

Netherlands

Facility Name

GSK Investigational Site

City

Zaandam

ZIP/Postal Code

1504 JA

Country

Netherlands

Osteoporosis

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial