OsteoporosisNCT00145067
Osteoporosis Disease Management Demonstration Project (0000-040)
A study testing Disease Management Assessment in people with Osteoporosis, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of the study is to evaluate the impact disease management interventions in treatment compliance among post-fracture and osteoporosis patients. 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?
- Disease Management Assessment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 230 participants
- Where
- No sites listed yet
- Study dates
- Nov 2003to Jun 2006
- Phase
- Interventional
- 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
- Members of of the Kaiser Permanente Health Plan who have fractured a bone.
Who cannot join
- Individuals who are not members of the Kaiser Permanente Health Plan.
About this study
Official title: Three Methods of Delivering Health Care for Secondary Prevention of Osteoporosis
The purpose of the study is to evaluate the impact disease management interventions in treatment compliance among post-fracture and osteoporosis patients.
- Conditions
- Osteoporosis
- Being tested
- Disease Management Assessment
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disease Management AssessmentBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment persistence
Secondary outcomes (1)
Patient satisfaction and knowledge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2005 (estimated)
- Study startNov 2003
- Primary completionJun 2006
- Study completionJun 2006
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.
- 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- 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
- NCT00145067
- Sponsor's protocol ID
- 0000-040
- Other IDs
- 040, 2005_051
- Status last verified
- Nov 2015
- First submitted
- 1 Sep 2005
- Last updated
- 3 Nov 2015
- Results posted
- No
Publications
Waalen J, Bruning AL, Peters MJ, Blau EM. A telephone-based intervention for increasing the use of osteoporosis medication: a randomized controlled trial. Am J Manag Care. 2009 Aug 1;15(8):e60-70.
PubMed 19659407
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three Methods of Delivering Health Care for Secondary Prevention of Osteoporosis
- ClinicalTrials.gov ID
- NCT00145067
- Acronym / sponsor ID
- 0000-040
- Conditions
- Osteoporosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Nov 2003
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 5 Sep 2005 (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.
The purpose of the study is to evaluate the impact disease management interventions in treatment compliance among post-fracture and osteoporosis patients.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Members of of the Kaiser Permanente Health Plan who have fractured a bone.
Key exclusion criteria (1 listed)
- Individuals who are not members of the Kaiser Permanente Health Plan.
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 |
|---|---|---|
| Disease Management Assessment | Behavioural | – |
Primary outcome
Treatment persistence
1 secondary outcome
Patient satisfaction and knowledge
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 3 Nov 2015.
- Derived from this study: PubMed 19659407Waalen J, Bruning AL, Peters MJ, Blau EM. A telephone-based intervention for increasing the use of osteoporosis medication: a randomized controlled trial. Am J Manag Care. 2009 Aug 1;15(8):e60-70.
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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 study testing Disease Management Assessment 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 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 3 Nov 2015. 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.
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?
Treatment persistence. 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 NCT00145067, 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 3 Nov 2015.