OsteoporosisPhase 3NCT00400530
Upper GI Handling of Branded vs. Generic Alendronate
A Phase 3 study testing MK0217, alendronate sodium / Duration of Treatment: 1 Month and Comparator: Alendronate-Teva / Duration of Treatment: 1 Month in people with Osteoporosis, run by Merck Sharp & Dohme LLC.
Trial summary
To compare upper GI handling of fosamax and generic, because the main AE profile of alendronate is before systemic absorption in the esophagus; differences could be relevant to the side effect profile. Read more about this study
- Who is it for?
- Ages 55 to 75 years, women only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- MK0217, alendronate sodium / Duration of Treatment: 1 Month and Comparator: Alendronate-Teva / Duration of Treatment: 1 Month
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Dec 2005to not given
- Phase
- Phase 3
- 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 55 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Post-menopausal females aged greater 55 years
- Prescribed alendronate 70 mg tablets for a therapeutic indication throughout the previous 3 months and expected to continue on this treatment for the duration of the study
- Willing to abstain from alcohol for 24 hours before each dose and until the end of each study day
- Willing to abstain from smoking for 24 hours before each dose and until the end of each study day
Who cannot join
- History of drug hypersensitivity
- Suffers from dysphagia, achalasia, or other conditions or medications affecting upper gastrointestinal motility
About this study
Official title: A Randomized, Single-Blind Study to Evaluate Upper Gastrointestinal Handling of Branded Versus Generic Alendronate Tablets
To compare upper GI handling of fosamax and generic, because the main AE profile of alendronate is before systemic absorption in the esophagus; differences could be relevant to the side effect profile.
- Conditions
- Osteoporosis
- Being tested
- MK0217, alendronate sodium / Duration of Treatment: 1 Month, Comparator: Alendronate-Teva / Duration of Treatment: 1 Month
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK0217, alendronate sodium / Duration of Treatment: 1 MonthDrug
Comparator: Alendronate-Teva / Duration of Treatment: 1 MonthDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Gamma camera imaging of tablet dissolution in oesophagus
Secondary outcomes (1)
Gamma camera dissolution of tablets in stomach
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2006 (estimated)
- Study startDec 2005
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 Merck Sharp & Dohme LLCThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Enrolment
- 25 participants
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00400530
- Sponsor's protocol ID
- 2006_050
- Status last verified
- Nov 2006
- First submitted
- 16 Nov 2006
- Last updated
- 17 Nov 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-Blind Study to Evaluate Upper Gastrointestinal Handling of Branded Versus Generic Alendronate Tablets
- ClinicalTrials.gov ID
- NCT00400530
- Acronym / sponsor ID
- 2006_050
- Conditions
- Osteoporosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- First posted
- 17 Nov 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.
To compare upper GI handling of fosamax and generic, because the main AE profile of alendronate is before systemic absorption in the esophagus; differences could be relevant to the side effect profile.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
Who may qualify
- Ages
- 55 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Post-menopausal females aged greater 55 years
- Prescribed alendronate 70 mg tablets for a therapeutic indication throughout the previous 3 months and expected to continue on this treatment for the duration of the study
- Willing to abstain from alcohol for 24 hours before each dose and until the end of each study day
- Willing to abstain from smoking for 24 hours before each dose and until the end of each study day
Key exclusion criteria (2 listed)
- History of drug hypersensitivity
- Suffers from dysphagia, achalasia, or other conditions or medications affecting upper gastrointestinal motility
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 |
|---|---|---|
| MK0217, alendronate sodium / Duration of Treatment: 1 Month | Drug | – |
| Comparator: Alendronate-Teva / Duration of Treatment: 1 Month | Drug | – |
Primary outcome
Gamma camera imaging of tablet dissolution in oesophagus
1 secondary outcome
Gamma camera dissolution of tablets in stomach
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 17 Nov 2006.
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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.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MK0217, alendronate sodium / Duration of Treatment: 1 Month and Comparator: Alendronate-Teva / Duration of Treatment: 1 Month in people with Osteoporosis, run by Merck Sharp & Dohme LLC.
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 4 inclusion and 2 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 17 Nov 2006. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Gamma camera imaging of tablet dissolution in oesophagus. 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 17 Nov 2006.