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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00327990
First received: May 18, 2006
Last updated: March 17, 2011
Last verified: March 2011
  Purpose

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 Intervention Phase
Osteoporosis
Drug: Ibandronate
Drug: Alendronate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: See Detailed Description

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

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.

Estimated Enrollment: 300
Study Start Date: April 2005
Intervention Details:
    Drug: Ibandronate Drug: Alendronate
    Other Names:
    • Ibandronate
    • 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).

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00327990

Locations
Netherlands
GSK Investigational Site
Bennebroek, Netherlands, 2121 BB
GSK Investigational Site
Breda, Netherlands, 4834 AD
GSK Investigational Site
Damwoude, Netherlands, 9104 GJ
GSK Investigational Site
Den Haag, Netherlands, 2584 HV
GSK Investigational Site
Den Haag, Netherlands, 2544 KM
GSK Investigational Site
Den Haag, Netherlands, 2582 LJ
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
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00327990     History of Changes
Other Study ID Numbers: IBN104125
Study First Received: May 18, 2006
Last Updated: March 17, 2011
Health Authority: Netherlands: Medicines Evaluation Board (MEB)

Keywords provided by GlaxoSmithKline:
ibandronate
osteoporosis
preference
case-finding
post-menopausal
alendronate

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases
Bone Diseases, Metabolic
Musculoskeletal Diseases
Alendronate
Ibandronic acid
Bone Density Conservation Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014