OsteoporosisNCT00949611
Wiser Choices in Osteoporosis Choice II: A Decision Aid for Patients and Clinicians
A study testing FRAX + Decision Aid and FRAX estimated fracture risk in people with Osteoporosis and Osteopenia, run by Mayo Clinic at 2 sites in United States.
Trial summary
Emphasis in treating osteoporosis has been on T-scores rather than overall fracture risk. Fracture Risk Assessment Tool (FRAX) supports a risk sensitive approach to osteoporosis treatment by providing an absolute fracture risk. Read more about this study
- Who is it for?
- Ages 50 to 90 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Osteopenia, Fragility Fractures
- What is being tested?
- FRAX + Decision Aid and FRAX estimated fracture risk
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2009to Feb 2011
- 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 50 to 90 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Peri and Postmenopausal Caucasian, Black, Hispanic and Asian women, aged 50-90
- Bone mineral density (BMD) T-Score < 1.0
- Have appointment with clinician to discuss test results and treatment options
- Patients with FRAX <20% risk who have taken a bisphosphonate for < 5 years.
Who cannot join
- Unable to speak or read English
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mayo Clinic
Rochester, Minnesota, 55901
Mayo Clinic
Rochester, Minnesota, 55902
About this study
Official title: Wiser Choices In Osteoporosis Choice II
Emphasis in treating osteoporosis has been on T-scores rather than overall fracture risk. Fracture Risk Assessment Tool (FRAX) supports a risk sensitive approach to osteoporosis treatment by providing an absolute fracture risk. FRAX combined with a decision aid may promote a shared decision making approach with patients, allowing the clinician and patient to weigh potential fracture risk (without treatment), versus risk reduction with medication (including side effects and costs). OSTEOPOROSIS CHOICE II will test the effectiveness of:
- FRAX
- FRAX + decision aid
- Usual care (no decision aid and no FRAX given to clinician)
- Conditions
- Osteoporosis, Osteopenia, Fragility Fractures
- Being tested
- FRAX + Decision Aid, FRAX estimated fracture risk
- Keywords
- Decision Aid, Shared Decision Making, Shared Medical Decision Making
- Medical subject headings
- Osteoporosis, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FRAX + Decision AidBehavioural
Also called Decision Support
Clinicians will present patient's with their individualized risk of osteoporotic fracture in 10 years, based on the FRAX risk calculator, as well as sharing a decision aid with them, which shows their risk of fracture, risk reduction on medications, as well as the downsides of the medications.
FRAX estimated fracture riskBehavioural
Also called Risk estimate
The clinician is provided with the patient's estimated risk of fracture as computed by the FRAX
| Study group | Role | What they receive |
|---|---|---|
| FRAX + Decision Aid | Experimental | Not described Receives: Behavioral: FRAX + Decision Aid |
| Usual care | No intervention | Not described |
| FRAX estimated fracture risk | Experimental | Not described Receives: Behavioral: FRAX estimated fracture risk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication start/stop, knowledge, and patient involvement.
Measured: Baseline and at 6 months
Secondary outcomes (1)
Decisional quality.
Measured: Baseline and 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 posted30 Jul 2009 (estimated)
- Study startMay 2009
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for Informed Medical Decision Making, Olmsted Medical Center
- Responsible party
- Principal investigator, Victor Montori, Mayo Clinic
- Investigators
- Victor M. Montori, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00949611
- Sponsor's protocol ID
- 08-006070
- Status last verified
- Feb 2016
- First submitted
- 28 Jul 2009
- Last updated
- 2 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
LeBlanc A, Wang AT, Wyatt K, Branda ME, Shah ND, Van Houten H, Pencille L, Wermers R, Montori VM. Encounter Decision Aid vs. Clinical Decision Support or Usual Care to Support Patient-Centered Treatment Decisions in Osteoporosis: The Osteoporosis Choice Randomized Trial II. PLoS One. 2015 May 26;10(5):e0128063. doi: 10.1371/journal.pone.0128063. eCollection 2015.
PubMed 26010755Wyatt KD, Branda ME, Inselman JW, Ting HH, Hess EP, Montori VM, LeBlanc A. Genders of patients and clinicians and their effect on shared decision making: a participant-level meta-analysis. BMC Med Inform Decis Mak. 2014 Sep 2;14:81. doi: 10.1186/1472-6947-14-81.
PubMed 25179289
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wiser Choices In Osteoporosis Choice II
- ClinicalTrials.gov ID
- NCT00949611
- Acronym / sponsor ID
- 08-006070
- Conditions
- Osteoporosis, Osteopenia, Fragility Fractures
- Keywords
- Decision Aid, Shared Decision Making, Shared Medical Decision Making
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Foundation for Informed Medical Decision Making, Olmsted Medical Center
- Study start
- May 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 30 Jul 2009 (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.
Emphasis in treating osteoporosis has been on T-scores rather than overall fracture risk. Fracture Risk Assessment Tool (FRAX) supports a risk sensitive approach to osteoporosis treatment by providing an absolute fracture risk. FRAX combined with a decision aid may promote a shared decision making approach with patients, allowing the clinician and patient to weigh potential fracture risk (without treatment), versus risk reduction with medication (including side effects and costs). OSTEOPOROSIS CHOICE II will test the effectiveness of:
- FRAX
- FRAX + decision aid
- Usual care (no decision aid and no FRAX given to clinician)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FRAX + Decision Aid | Experimental | Behavioral: FRAX + Decision Aid |
| Usual care | No intervention | – |
| FRAX estimated fracture risk | Experimental | Behavioral: FRAX estimated fracture risk |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Peri and Postmenopausal Caucasian, Black, Hispanic and Asian women, aged 50-90
- Bone mineral density (BMD) T-Score < 1.0
- Have appointment with clinician to discuss test results and treatment options
- Patients with FRAX <20% risk who have taken a bisphosphonate for < 5 years.
Key exclusion criteria (1 listed)
- Unable to speak or read English
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 |
|---|---|---|
| FRAX + Decision AidAlso: Decision SupportClinicians will present patient's with their individualized risk of osteoporotic fracture in 10 years, based on the FRAX risk calculator, as well as sharing a decision aid with them, which shows their risk of fracture, risk reduction on medications, as well as the downsides of the medications. | Behavioural | FRAX + Decision Aid |
| FRAX estimated fracture riskAlso: Risk estimateThe clinician is provided with the patient's estimated risk of fracture as computed by the FRAX | Behavioural | FRAX estimated fracture risk |
Primary outcome
Medication start/stop, knowledge, and patient involvement.
Time frame: Baseline and at 6 months
1 secondary outcome
Decisional quality.
Time frame: Baseline and 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 2 Feb 2016.
- Derived from this study: PubMed 26010755LeBlanc A, Wang AT, Wyatt K, Branda ME, Shah ND, Van Houten H, Pencille L, Wermers R, Montori VM. Encounter Decision Aid vs. Clinical Decision Support or Usual Care to Support Patient-Centered Treatment Decisions in Osteoporosis: The Osteoporosis Choice Randomized Trial II. PLoS One. 2015 May 26;10(5):e0128063. doi: 10.1371/journal.pone.0128063. eCollection 2015.
- Derived from this study: PubMed 25179289Wyatt KD, Branda ME, Inselman JW, Ting HH, Hess EP, Montori VM, LeBlanc A. Genders of patients and clinicians and their effect on shared decision making: a participant-level meta-analysis. BMC Med Inform Decis Mak. 2014 Sep 2;14:81. doi: 10.1186/1472-6947-14-81.
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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.
Victor M. Montori, M.D. principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FRAX + Decision Aid and FRAX estimated fracture risk in people with Osteoporosis and Osteopenia, run by Mayo Clinic at 2 sites in United States.
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 4 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 2 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Medication start/stop, knowledge, and patient involvement. (time frame: Baseline and at 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 NCT00949611, which also lists 2 linked publications.
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 2 Feb 2016.