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

Condition(s) targeted: Osteoporosis

Intervention: Ibandronate (Drug); Alendronate (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline

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.

Official title: See Detailed Description

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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: 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.

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).

Minimum age: 60 Years. Maximum age: N/A. Gender(s): Female.

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.

GSK Investigational Site, Bennebroek 2121 BB, Netherlands

GSK Investigational Site, Breda 4834 AD, Netherlands

GSK Investigational Site, Damwoude 9104 GJ, Netherlands

GSK Investigational Site, Den Haag 2544 KM, Netherlands

GSK Investigational Site, Den Haag 2582 LJ, Netherlands

GSK Investigational Site, Den Haag 2584 HV, Netherlands

GSK Investigational Site, Driebergen-rijsenburg 3972 WG, Netherlands

GSK Investigational Site, Easterein 8734 CG, Netherlands

GSK Investigational Site, Eersel 5521 CD, Netherlands

GSK Investigational Site, Eindhoven 5613 BE, Netherlands

GSK Investigational Site, Enschede 7544 NZ, Netherlands

GSK Investigational Site, Etten-leur 4872 LA, Netherlands

GSK Investigational Site, Geleen 6163 GC, Netherlands

GSK Investigational Site, Groesbeek 6561 CM, Netherlands

GSK Investigational Site, Heerlen 6417 BR, Netherlands

GSK Investigational Site, Hengelo 7255 AM, Netherlands

GSK Investigational Site, Hoogvliet 3192 JN, Netherlands

GSK Investigational Site, Hoogwoud 1718 BG, Netherlands

GSK Investigational Site, Hulst 4561 CJ, Netherlands

GSK Investigational Site, Landgraaf 6373 JS, Netherlands

GSK Investigational Site, Losser 7581 BV, Netherlands

GSK Investigational Site, Midwoud 1679 GJ, Netherlands

GSK Investigational Site, Nijverdal 7442 LS, Netherlands

GSK Investigational Site, Nunspeet 8071 LX, Netherlands

GSK Investigational Site, Oldebroek 8096 AV, Netherlands

GSK Investigational Site, Oudenbosch 4731 MA, Netherlands

GSK Investigational Site, Poortvliet 4693 BT, Netherlands

GSK Investigational Site, Prinsenbeek 4841 RR, Netherlands

GSK Investigational Site, Raalte 8101 ZW, Netherlands

GSK Investigational Site, Ridderkerk 2985 VG, Netherlands

GSK Investigational Site, Rotterdam 3082 DC, Netherlands

GSK Investigational Site, Spijkenisse 3207 NB, Netherlands

GSK Investigational Site, Tilburg 5038 DE, Netherlands

GSK Investigational Site, Voerendaal 6367 ED, Netherlands

GSK Investigational Site, Wassenaar 2241 KE, Netherlands

GSK Investigational Site, Wildervank 9648 BE, Netherlands

GSK Investigational Site, Woerden 3443 GG, Netherlands

GSK Investigational Site, Zaandam 1504 JA, Netherlands

Starting date: April 2005
Last updated: March 17, 2011