OsteoporosisNCT00139425
Osteoporosis Disease Management Demonstration Project (0000-037)
A study testing Disease Management Assessment in people with Osteoporosis, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of this study is to assess the impact of disease management interventions on bone mineral density (BMD) screening rates and osteoporosis treatment rates in women age 65 years or older. Read more about this study
- Who is it for?
- Ages 65 to 89 years, 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
- 10,000 participants
- Where
- No sites listed yet
- Study dates
- May 2003to Dec 2004
- 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 65 to 89 years
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- Members of the Henry Ford Health System
Who cannot join
- Individuals who are not members of the Henry Ford Health System
About this study
Official title: Osteoporosis Prevention and Treatment Program: A Disease Management Demonstration Project
The purpose of this study is to assess the impact of disease management interventions on bone mineral density (BMD) screening rates and osteoporosis treatment rates in women age 65 years or older.
- 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.
Bone mineral density (BMD) testing rates
Secondary outcomes (1)
Osteoporosis medication treatment rates
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2005 (estimated)
- Study startMay 2003
- Primary completionDec 2004
- Study completionDec 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 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
- 10,000 participants
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
- NCT00139425
- Sponsor's protocol ID
- 0000-037
- Other IDs
- 037, 2005_048
- Status last verified
- Apr 2016
- First submitted
- 29 Aug 2005
- Last updated
- 22 Apr 2016
- Results posted
- No
Publications
Lafata JE, Kolk D, Peterson EL, McCarthy BD, Weiss TW, Chen YT, Muma BK. Improving osteoporosis screening: results from a randomized cluster trial. J Gen Intern Med. 2007 Mar;22(3):346-51. doi: 10.1007/s11606-006-0060-9.
PubMed 17356966
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteoporosis Prevention and Treatment Program: A Disease Management Demonstration Project
- ClinicalTrials.gov ID
- NCT00139425
- Acronym / sponsor ID
- 0000-037
- Conditions
- Osteoporosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10,000 participants
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- May 2003
- Primary completion
- Dec 2004 (actual)
- Study completion
- Dec 2004 (actual)
- First posted
- 31 Aug 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 this study is to assess the impact of disease management interventions on bone mineral density (BMD) screening rates and osteoporosis treatment rates in women age 65 years or older.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 65 to 89 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Members of the Henry Ford Health System
Key exclusion criteria (1 listed)
- Individuals who are not members of the Henry Ford Health 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 |
|---|---|---|
| Disease Management Assessment | Behavioural | – |
Primary outcome
Bone mineral density (BMD) testing rates
1 secondary outcome
Osteoporosis medication treatment rates
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 22 Apr 2016.
- Derived from this study: PubMed 17356966Lafata JE, Kolk D, Peterson EL, McCarthy BD, Weiss TW, Chen YT, Muma BK. Improving osteoporosis screening: results from a randomized cluster trial. J Gen Intern Med. 2007 Mar;22(3):346-51. doi: 10.1007/s11606-006-0060-9.
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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 22 Apr 2016. 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?
Bone mineral density (BMD) testing rates. 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 NCT00139425, 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 22 Apr 2016.