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

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT00327990

Collaborator

(none)

300

Enrollment

Locations

Duration (Months)

7.9

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis	Drug: Ibandronate Drug: Alendronate	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Apr 1, 2005

Actual Primary Completion Date :

Dec 1, 2006

Actual Study Completion Date :

Dec 1, 2006

Outcome Measures

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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

Female

Accepts 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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	GSK Investigational Site	Bennebroek	Netherlands	2121 BB
2	GSK Investigational Site	Breda	Netherlands	4834 AD
3	GSK Investigational Site	Damwoude	Netherlands	9104 GJ
4	GSK Investigational Site	Den Haag	Netherlands	2544 KM
5	GSK Investigational Site	Den Haag	Netherlands	2582 LJ
6	GSK Investigational Site	Den Haag	Netherlands	2584 HV
7	GSK Investigational Site	Driebergen-rijsenburg	Netherlands	3972 WG
8	GSK Investigational Site	Easterein	Netherlands	8734 CG
9	GSK Investigational Site	Eersel	Netherlands	5521 CD
10	GSK Investigational Site	Eindhoven	Netherlands	5613 BE
11	GSK Investigational Site	Enschede	Netherlands	7544 NZ
12	GSK Investigational Site	Etten-leur	Netherlands	4872 LA
13	GSK Investigational Site	Geleen	Netherlands	6163 GC
14	GSK Investigational Site	Groesbeek	Netherlands	6561 CM
15	GSK Investigational Site	Heerlen	Netherlands	6417 BR
16	GSK Investigational Site	Hengelo	Netherlands	7255 AM
17	GSK Investigational Site	Hoogvliet	Netherlands	3192 JN
18	GSK Investigational Site	Hoogwoud	Netherlands	1718 BG
19	GSK Investigational Site	Hulst	Netherlands	4561 CJ
20	GSK Investigational Site	Landgraaf	Netherlands	6373 JS
21	GSK Investigational Site	Losser	Netherlands	7581 BV
22	GSK Investigational Site	Midwoud	Netherlands	1679 GJ
23	GSK Investigational Site	Nijverdal	Netherlands	7442 LS
24	GSK Investigational Site	Nunspeet	Netherlands	8071 LX
25	GSK Investigational Site	Oldebroek	Netherlands	8096 AV
26	GSK Investigational Site	Oudenbosch	Netherlands	4731 MA
27	GSK Investigational Site	Poortvliet	Netherlands	4693 BT
28	GSK Investigational Site	Prinsenbeek	Netherlands	4841 RR
29	GSK Investigational Site	Raalte	Netherlands	8101 ZW
30	GSK Investigational Site	Ridderkerk	Netherlands	2985 VG
31	GSK Investigational Site	Rotterdam	Netherlands	3082 DC
32	GSK Investigational Site	Spijkenisse	Netherlands	3207 NB
33	GSK Investigational Site	Tilburg	Netherlands	5038 DE
34	GSK Investigational Site	Voerendaal	Netherlands	6367 ED
35	GSK Investigational Site	Wassenaar	Netherlands	2241 KE
36	GSK Investigational Site	Wildervank	Netherlands	9648 BE
37	GSK Investigational Site	Woerden	Netherlands	3443 GG
38	GSK Investigational Site	Zaandam	Netherlands	1504 JA