OsteoporosisPhase 3NCT00480766
A Research Study to Evaluate the Safety and Effectiveness of MK0217 to Prevent and Treat Bone Loss (0217-193)(COMPLETED)
A Phase 3 study testing MK0217/Duration of Treatment : 12 Months in people with Osteoporosis, run by Organon and Co.
Trial summary
A research study to see how safe and effective MK0217 is when taken weekly for the prevention and treatment of steroid induced bone loss. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Osteoporosis
- What is being tested?
- MK0217/Duration of Treatment : 12 Months
- How many people
- 173 participants
- Where
- No sites listed yet
- Study dates
- Jul 2001to Aug 2003
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Man or woman aged 18 to 80 years, being treated with oral glucocorticoid (steroid), without vertebral fracture or prior osteoporotic fracture
Who cannot join
- Mentally or legally incompetent, pregnant, alcohol or drug dependence, history of heart disease, kidney disease, hypertension, upper gastrointestinal disease, cancer, being treated with hormone replacement therapy, or life expectancy of less than 3 years
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, 12-Month Study to Evaluate the Efficacy and Safety of Oral Alendronate Sodium Once Weekly for the Prevention and Treatment of Glucocorticoid-Induced Bone Loss
A research study to see how safe and effective MK0217 is when taken weekly for the prevention and treatment of steroid induced bone loss.
- Conditions
- Osteoporosis
- Being tested
- MK0217/Duration of Treatment : 12 Months
- Keywords
- Glucocorticoid
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK0217/Duration of Treatment : 12 MonthsDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the effect of patients taking MK0217 once weekly along with steroids for a 12 month period by checking the percentage change of bone mineral density as compared to patients taking placebo
Secondary outcomes (1)
Describe how safe and tolerable the drug MK0217 is when patients take it once weekly over 3 months
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 startJul 2001
- Primary completionAug 2003
- Study completionAug 2003
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 OsteoporosisStudies 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
- 173 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
- NCT00480766
- Sponsor's protocol ID
- 0217-193
- Other IDs
- 2007_560
- Status last verified
- Feb 2022
- First submitted
- 30 May 2007
- Last updated
- 14 Aug 2024
- Results posted
- No
Publications
Stoch SA, Saag KG, Greenwald M, Sebba AI, Cohen S, Verbruggen N, Giezek H, West J, Schnitzer TJ. Once-weekly oral alendronate 70 mg in patients with glucocorticoid-induced bone loss: a 12-month randomized, placebo-controlled clinical trial. J Rheumatol. 2009 Aug;36(8):1705-14. doi: 10.3899/jrheum.081207. Epub 2009 Jun 1.
PubMed 19487264
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 Multicenter, Randomized, Double-Blind, Placebo-Controlled, 12-Month Study to Evaluate the Efficacy and Safety of Oral Alendronate Sodium Once Weekly for the Prevention and Treatment of Glucocorticoid-Induced Bone Loss
- ClinicalTrials.gov ID
- NCT00480766
- Acronym / sponsor ID
- 0217-193
- Conditions
- Osteoporosis
- Keywords
- Glucocorticoid
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Jul 2001
- Primary completion
- Aug 2003 (actual)
- Study completion
- Aug 2003 (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.
A research study to see how safe and effective MK0217 is when taken weekly for the prevention and treatment of steroid induced bone loss.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Man or woman aged 18 to 80 years, being treated with oral glucocorticoid (steroid), without vertebral fracture or prior osteoporotic fracture
Key exclusion criteria (1 listed)
- Mentally or legally incompetent, pregnant, alcohol or drug dependence, history of heart disease, kidney disease, hypertension, upper gastrointestinal disease, cancer, being treated with hormone replacement therapy, or life expectancy of less than 3 years
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/Duration of Treatment : 12 Months | Drug | – |
Primary outcome
Assess the effect of patients taking MK0217 once weekly along with steroids for a 12 month period by checking the percentage change of bone mineral density as compared to patients taking placebo
1 secondary outcome
Describe how safe and tolerable the drug MK0217 is when patients take it once weekly over 3 months
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 19487264Stoch SA, Saag KG, Greenwald M, Sebba AI, Cohen S, Verbruggen N, Giezek H, West J, Schnitzer TJ. Once-weekly oral alendronate 70 mg in patients with glucocorticoid-induced bone loss: a 12-month randomized, placebo-controlled clinical trial. J Rheumatol. 2009 Aug;36(8):1705-14. doi: 10.3899/jrheum.081207. Epub 2009 Jun 1.
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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/Duration of Treatment : 12 Months in people with Osteoporosis, 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 1 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?
Assess the effect of patients taking MK0217 once weekly along with steroids for a 12 month period by checking the percentage change of bone mineral density as compared to patients taking placebo. 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 NCT00480766, 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.