Paget's Disease of BonePhase 3NCT00480662
A Research Study to Test the Effectiveness of MK0217 in Patients With Paget's Bone Disease (0217-206)(COMPLETED)
A Phase 3 study testing alendronate in people with Paget's Disease of Bone, run by Organon and Co.
Trial summary
To test the safety, effectiveness of MK0217 when taken once a week for six months in treating patients with Paget's bone disease. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Paget's Disease of Bone
- What is being tested?
- alendronate
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Oct 2001to Oct 2002
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, ages 18 to 90 years with a diagnosis of Paget's bone disease
Who cannot join
- Patient cannot stand or sit upright for at least 30 minutes
- Patient has difficulty swallowing or problems with digestive system
About this study
Official title: A 6-Month, Multicenter, Double-Blind, Randomized, Active-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Alendronate 280-mg Oral Buffered Solution Once Weekly in Patients With Paget's Disease of Bone
To test the safety, effectiveness of MK0217 when taken once a week for six months in treating patients with Paget's bone disease.
- Conditions
- Paget's Disease of Bone
- Being tested
- alendronate
- Keywords
- Paget's bone disease
- Medical subject headings
- Osteitis Deformans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alendronateDrug
Also called MK0217
Duration of Treatment : 6 Months
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients will have a decrease of at least 30% in their blood alkaline phosphatase level after 6 months
Secondary outcomes (1)
MK0217 will be safely tolerated
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2007 (estimated)
- Study startOct 2001
- Primary completionOct 2002
- Study completionOct 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Paget's Disease of BoneStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00480662
- Sponsor's protocol ID
- 0217-206
- Other IDs
- MK0217-206, 2007_555
- Status last verified
- Feb 2022
- First submitted
- 30 May 2007
- Last updated
- 14 Aug 2024
- Results posted
- No
Publications
Hooper M, Faustino A, Reid IR, Hosking D, Gilchrist NL, Selby P, Wu M, Salzmann G, West J, Leung A. Randomized, active-controlled study of once-weekly alendronate 280 mg high dose oral buffered solution for treatment of Paget's disease. Osteoporos Int. 2009 Jan;20(1):141-50. doi: 10.1007/s00198-008-0639-6. Epub 2008 Jun 7.
PubMed 18536953
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 6-Month, Multicenter, Double-Blind, Randomized, Active-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Alendronate 280-mg Oral Buffered Solution Once Weekly in Patients With Paget's Disease of Bone
- ClinicalTrials.gov ID
- NCT00480662
- Acronym / sponsor ID
- 0217-206
- Conditions
- Paget's Disease of Bone
- Keywords
- Paget's bone disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Oct 2001
- Primary completion
- Oct 2002 (actual)
- Study completion
- Oct 2002 (actual)
- First posted
- 31 May 2007 (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 test the safety, effectiveness of MK0217 when taken once a week for six months in treating patients with Paget's bone disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male or female, ages 18 to 90 years with a diagnosis of Paget's bone disease
Key exclusion criteria (2 listed)
- Patient cannot stand or sit upright for at least 30 minutes
- Patient has difficulty swallowing or problems with digestive system
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 |
|---|---|---|
| alendronateAlso: MK0217Duration of Treatment : 6 Months | Drug | – |
Primary outcome
Patients will have a decrease of at least 30% in their blood alkaline phosphatase level after 6 months
1 secondary outcome
MK0217 will be safely tolerated
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 14 Aug 2024.
- Results publication: PubMed 18536953Hooper M, Faustino A, Reid IR, Hosking D, Gilchrist NL, Selby P, Wu M, Salzmann G, West J, Leung A. Randomized, active-controlled study of once-weekly alendronate 280 mg high dose oral buffered solution for treatment of Paget's disease. Osteoporos Int. 2009 Jan;20(1):141-50. doi: 10.1007/s00198-008-0639-6. Epub 2008 Jun 7.
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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 alendronate in people with Paget's Disease of Bone, run by Organon and Co.
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 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 14 Aug 2024. 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?
Patients will have a decrease of at least 30% in their blood alkaline phosphatase level after 6 months. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00480662, which also lists 1 linked publication.
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 14 Aug 2024; AzTrials last refreshed its copy on 6 Nov 2026.