Postmenopausal OsteoporosisPhase 3NCT00092027
A Study to Evaluate the Safety and Tolerability of MK0217 in Women (0217-219)
A Phase 3 study testing MK0217, alendronate sodium/Duration of Treatment: 6 months in people with Postmenopausal Osteoporosis, run by Organon and Co.
Trial summary
This study is to assess the safety and tolerability of MK0217 being evaluated to treat women with postmenopausal osteoporosis. Read more about this study
- Who is it for?
- Ages 25 years and older, women only
- Conditions the study is for
- Postmenopausal Osteoporosis
- What is being tested?
- MK0217, alendronate sodium/Duration of Treatment: 6 months
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 454 participants
- Where
- No sites listed yet
- Study dates
- 19 Mar 2003to 15 Mar 2004
- 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 25 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with postmenopausal osteoporosis
Who cannot join
- High risk for fractures
- Esophageal abnormalities
- Upper gastrointestinal symptoms that are not relieved with medication
- Metabolic bone disease (example - vitamin D deficiency)
- Medications that would affect the breakdown or build-up of bone
About this study
Official title: A Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Compare the Safety and Tolerability of an Oral Buffered Solution of Alendronate Sodium 70 mg Once-Weekly Versus Placebo for the Treatment of Osteoporosis in Postmenopausal Women
This study is to assess the safety and tolerability of MK0217 being evaluated to treat women with postmenopausal osteoporosis.
- Conditions
- Postmenopausal Osteoporosis
- Being tested
- MK0217, alendronate sodium/Duration of Treatment: 6 months, Comparator: placebo / Duration of Treatment: 6 months
- Medical subject headings
- Osteoporosis, Postmenopausal
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: 6 monthsDrug
Comparator: placebo / Duration of Treatment: 6 monthsDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the upper gastrointestinal (UGI) safety and tolerability of 6 months of treatment with once weekly alendronate 70 mg in an oral buffered solution in comparison to placebo in postmenopausal women with osteoporosis
Secondary outcomes (2)
To evaluate the overall safety and tolerability of once weekly alendronate 70 mg oral buffered solution versus placebo
To evaluate the mean percent change from baseline in bone markers (BSAP, Urinary NTx) at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2004 (estimated)
- Study start19 Mar 2003
- Primary completion15 Mar 2004
- Study completion15 Mar 2004
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 Postmenopausal 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
- 454 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
- NCT00092027
- Sponsor's protocol ID
- 0217-219
- Other IDs
- MK0217-219, 2004_017
- Status last verified
- Feb 2022
- First submitted
- 21 Sep 2004
- Last updated
- 14 Aug 2024
- Results posted
- No
Publications
Cryer B, Binkley N, Simonelli C, Lewiecki EM, Lanza F, Chen E, Petruschke RA, Mullen C, de Papp AE. A randomized, placebo-controlled, 6-month study of once-weekly alendronate oral solution for postmenopausal osteoporosis. Am J Geriatr Pharmacother. 2005 Sep;3(3):127-36. doi: 10.1016/s1543-5946(05)80019-4.
PubMed 16257815
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 Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Compare the Safety and Tolerability of an Oral Buffered Solution of Alendronate Sodium 70 mg Once-Weekly Versus Placebo for the Treatment of Osteoporosis in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT00092027
- Acronym / sponsor ID
- 0217-219
- Conditions
- Postmenopausal Osteoporosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 454 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 19 Mar 2003 (actual)
- Primary completion
- 15 Mar 2004 (actual)
- Study completion
- 15 Mar 2004 (actual)
- First posted
- 24 Sep 2004 (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 study is to assess the safety and tolerability of MK0217 being evaluated to treat women with postmenopausal osteoporosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women with postmenopausal osteoporosis
Key exclusion criteria (5 listed)
- High risk for fractures
- Esophageal abnormalities
- Upper gastrointestinal symptoms that are not relieved with medication
- Metabolic bone disease (example - vitamin D deficiency)
- Medications that would affect the breakdown or build-up of bone
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: 6 months | Drug | – |
| Comparator: placebo / Duration of Treatment: 6 months | Drug | – |
Primary outcome
To evaluate the upper gastrointestinal (UGI) safety and tolerability of 6 months of treatment with once weekly alendronate 70 mg in an oral buffered solution in comparison to placebo in postmenopausal women with osteoporosis
2 secondary outcomes
To evaluate the overall safety and tolerability of once weekly alendronate 70 mg oral buffered solution versus placebo
To evaluate the mean percent change from baseline in bone markers (BSAP, Urinary NTx) at 6 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.
- Background: PubMed 16257815Cryer B, Binkley N, Simonelli C, Lewiecki EM, Lanza F, Chen E, Petruschke RA, Mullen C, de Papp AE. A randomized, placebo-controlled, 6-month study of once-weekly alendronate oral solution for postmenopausal osteoporosis. Am J Geriatr Pharmacother. 2005 Sep;3(3):127-36. doi: 10.1016/s1543-5946(05)80019-4.
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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: 6 months in people with Postmenopausal 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 5 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?
To evaluate the upper gastrointestinal (UGI) safety and tolerability of 6 months of treatment with once weekly alendronate 70 mg in an oral buffered solution in comparison to placebo in postmenopausal women with osteoporosis. 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 NCT00092027, 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.