OsteoporosisPhase 4NCT00327990
Evaluation Of Missed Osteoporosis Diagnoses, And Preference Between Once Monthly Ibandronate And Once Weekly Alendronate
A Phase 4 study testing Ibandronate and Alendronate in people with Osteoporosis, run by GlaxoSmithKline at 38 sites in Netherlands.
Trial 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). Read more about this study
- Who is it for?
- Ages 60 years and older, women only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Ibandronate and Alendronate
- How many people
- 300 participants
- Where
- 38 sitesNetherlands
- Study dates
- Apr 2005to Dec 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women registered with a GP, without a prior history of osteoporosis. According to a case-finding procedure, osteoporosis will be diagnosed or excluded.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
38 sites in 1 country.
38 sites in 1 country
Netherlands38 sites
GSK Investigational Site
Bennebroek, 2121 BB
GSK Investigational Site
Breda, 4834 AD
GSK Investigational Site
Damwoude, 9104 GJ
GSK Investigational Site
Driebergen-Rijsenburg, 3972 WG
GSK Investigational Site
Eersel, 5521 CD
GSK Investigational Site
Eindhoven, 5613 BE
GSK Investigational Site
Enschede, 7544 NZ
GSK Investigational Site
Etten-Leur, 4872 LA
GSK Investigational Site
Geleen, 6163 GC
GSK Investigational Site
Groesbeek, 6561 CM
GSK Investigational Site
Heerlen, 6417 BR
GSK Investigational Site
Hengelo, 7255 AM
GSK Investigational Site
Hoogvliet, 3192 JN
GSK Investigational Site
Hoogwoud, 1718 BG
GSK Investigational Site
Hulst, 4561 CJ
GSK Investigational Site
Landgraaf, 6373 JS
GSK Investigational Site
Losser, 7581 BV
GSK Investigational Site
Midwoud, 1679 GJ
GSK Investigational Site
Nijverdal, 7442 LS
GSK Investigational Site
Nunspeet, 8071 LX
GSK Investigational Site
Oldebroek, 8096 AV
GSK Investigational Site
Oosterend, 8734 CG
GSK Investigational Site
Oudenbosch, 4731 MA
GSK Investigational Site
Poortvliet, 4693 BT
GSK Investigational Site
Prinsenbeek, 4841 RR
GSK Investigational Site
Raalte, 8101 ZW
GSK Investigational Site
Ridderkerk, 2985 VG
GSK Investigational Site
Rotterdam, 3082 DC
GSK Investigational Site
Spijkenisse, 3207 NB
GSK Investigational Site
The Hague, 2544 KM
GSK Investigational Site
The Hague, 2582 LJ
GSK Investigational Site
The Hague, 2584 HV
GSK Investigational Site
Tilburg, 5038 DE
GSK Investigational Site
Voerendaal, 6367 ED
GSK Investigational Site
Wassenaar, 2241 KE
GSK Investigational Site
Wildervank, 9648 BE
GSK Investigational Site
Woerden, 3443 GG
GSK Investigational Site
Zaandam, 1504 JA
About this study
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)
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.
Read the 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).
- Conditions
- Osteoporosis
- Being tested
- Ibandronate, Alendronate
- Keywords
- ibandronate, osteoporosis, preference, case-finding, post-menopausal, alendronate
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbandronateDrug
AlendronateDrug
Also called Ibandronate
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2006 (estimated)
- Study startApr 2005
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, MD, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00327990
- Sponsor's protocol ID
- IBN104125
- Status last verified
- May 2017
- First submitted
- 18 May 2006
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00327990
- Acronym / sponsor ID
- IBN104125
- Conditions
- Osteoporosis
- Keywords
- ibandronate, osteoporosis, preference, case-finding, post-menopausal, alendronate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 19 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women registered with a GP, without a prior history of osteoporosis. According to a case-finding procedure, osteoporosis will be diagnosed or excluded.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ibandronate | Drug | – |
| AlendronateAlso: Ibandronate | Drug | – |
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
1 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials, MD study director
GlaxoSmithKline
38 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ibandronate and Alendronate in people with Osteoporosis, run by GlaxoSmithKline at 38 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017; AzTrials last refreshed its copy on 7 Nov 2026.