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

NCT00327990 | Completed Phase 4

• 1 other identifier: IBN104125
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 38

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.

Conditions

Osteoporosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Interventions

Ibandronate DRUG

Alendronate DRUG

Also known as: Ibandronate

Eligibility Criteria

• Age: 60 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women registered with a GP, without a prior history of osteoporosis. According to a case-finding procedure, osteoporosis will be diagnosed or excluded.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (38)

GSK Investigational Site

Bennebroek, 2121 BB, Netherlands

Location

GSK Investigational Site

Breda, 4834 AD, Netherlands

Location

GSK Investigational Site

Damwoude, 9104 GJ, Netherlands

Location

GSK Investigational Site

Driebergen-Rijsenburg, 3972 WG, Netherlands

Location

GSK Investigational Site

Eersel, 5521 CD, Netherlands

Location

GSK Investigational Site

Eindhoven, 5613 BE, Netherlands

Location

GSK Investigational Site

Enschede, 7544 NZ, Netherlands

Location

GSK Investigational Site

Etten-Leur, 4872 LA, Netherlands

Location

GSK Investigational Site

Geleen, 6163 GC, Netherlands

Location

GSK Investigational Site

Groesbeek, 6561 CM, Netherlands

Location

GSK Investigational Site

Heerlen, 6417 BR, Netherlands

Location

GSK Investigational Site

Hengelo, 7255 AM, Netherlands

Location

GSK Investigational Site

Hoogvliet, 3192 JN, Netherlands

Location

GSK Investigational Site

Hoogwoud, 1718 BG, Netherlands

Location

GSK Investigational Site

Hulst, 4561 CJ, Netherlands

Location

GSK Investigational Site

Landgraaf, 6373 JS, Netherlands

Location

GSK Investigational Site

Losser, 7581 BV, Netherlands

Location

GSK Investigational Site

Midwoud, 1679 GJ, Netherlands

Location

GSK Investigational Site

Nijverdal, 7442 LS, Netherlands

Location

GSK Investigational Site

Nunspeet, 8071 LX, Netherlands

Location

GSK Investigational Site

Oldebroek, 8096 AV, Netherlands

Location

GSK Investigational Site

Oosterend, 8734 CG, Netherlands

Location

GSK Investigational Site

Oudenbosch, 4731 MA, Netherlands

Location

GSK Investigational Site

Poortvliet, 4693 BT, Netherlands

Location

GSK Investigational Site

Prinsenbeek, 4841 RR, Netherlands

Location

GSK Investigational Site

Raalte, 8101 ZW, Netherlands

Location

GSK Investigational Site

Ridderkerk, 2985 VG, Netherlands

Location

GSK Investigational Site

Rotterdam, 3082 DC, Netherlands

Location

GSK Investigational Site

Spijkenisse, 3207 NB, Netherlands

Location

GSK Investigational Site

The Hague, 2544 KM, Netherlands

Location

GSK Investigational Site

The Hague, 2582 LJ, Netherlands

Location

GSK Investigational Site

The Hague, 2584 HV, Netherlands

Location

GSK Investigational Site

Tilburg, 5038 DE, Netherlands

Location

GSK Investigational Site

Voerendaal, 6367 ED, Netherlands

Location

GSK Investigational Site

Wassenaar, 2241 KE, Netherlands

Location

GSK Investigational Site

Wildervank, 9648 BE, Netherlands

Location

GSK Investigational Site

Woerden, 3443 GG, Netherlands

Location

GSK Investigational Site

Zaandam, 1504 JA, Netherlands

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

Ibandronic Acid; Alendronate

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals

Study Officials

• GSK Clinical Trials, MD

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2006
• First Posted: May 19, 2006
• Study Start: April 1, 2005
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: May 30, 2017

Record last verified: 2017-05

Locations

NL (38)