NCT00578981

Brief Summary

To develop a decision aid to support the decision to use (or not use) bisphosphonates in postmenopausal women at risk for osteoporotic fractures, and to assess the impact of the decision aid on start and six month adherence to bisphosphonates.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 21, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

February 2, 2016

Status Verified

February 1, 2016

Enrollment Period

11 months

First QC Date

December 20, 2007

Last Update Submit

February 1, 2016

Conditions

OsteoporosisBone Loss, Age RelatedPostmenopausal Bone LossPostmenopausal Osteoporosis

Keywords

Osteoporosis, age-relatedOsteoporosis, PostmenopausalBone LossLow Bone Density

Outcome Measures

Primary Outcomes (1)

  • Evidence of success of decision aid to providers and patients, which leads to improved knowledge, reduced decisional conflict and enhanced satisfaction with the decision, and enhanced adherence to medication.

    Directly following intervention.

Secondary Outcomes (1)

  • Evaluate ability to recruit participants and collect patient outcomes.

    One year after start of study.

Study Arms (2)

Arm 1

EXPERIMENTAL
Behavioral: Osteoporosis Choice Decision Aid

Arm 2

NO INTERVENTION

Interventions

Osteoporosis Choice Decision AidBEHAVIORAL

The provider will introduce the patient to the choice of bisphosphonates using the decision aid.

Arm 1

Eligibility Criteria

Age50 Years - 90 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female, post-menopausal women aged 50 to 90.
  • Have a bone mineral density (BMD) evaluation resulting in a T-Score of \<-1.0.
  • Have a follow-up appointment with a provider in the areas of Family Medicine (FM), Primary Care Internal Medicine (PCIM), or POM.
  • Have no major barriers (i.e., severe hearing impairment, dementia, require interpreter, etc.) to participation in shared decision-making (per provider's assessment)
  • Enrollment is open to females of diverse racial backgrounds.

You may not qualify if:

  • Currently taking a bisphosphonate.
  • Not available for 6 month follow-up phone call.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (3)

  • Wyatt 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.

    PMID: 25179289DERIVED

  • Montori VM, Shah ND, Pencille LJ, Branda ME, Van Houten HK, Swiglo BA, Kesman RL, Tulledge-Scheitel SM, Jaeger TM, Johnson RE, Bartel GA, Melton LJ 3rd, Wermers RA. Use of a decision aid to improve treatment decisions in osteoporosis: the osteoporosis choice randomized trial. Am J Med. 2011 Jun;124(6):549-56. doi: 10.1016/j.amjmed.2011.01.013.

    PMID: 21605732DERIVED

  • Pencille LJ, Campbell ME, Van Houten HK, Shah ND, Mullan RJ, Swiglo BA, Breslin M, Kesman RL, Tulledge-Scheitel SM, Jaeger TM, Johnson RE, Bartel GA, Wermers RA, Melton LJ 3rd, Montori VM. Protocol for the Osteoporosis Choice trial. A pilot randomized trial of a decision aid in primary care practice. Trials. 2009 Dec 10;10:113. doi: 10.1186/1745-6215-10-113.

    PMID: 20003299DERIVED

MeSH Terms

Conditions

OsteoporosisOsteoporosis, PostmenopausalBone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Victor M. Montori, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 20, 2007

First Posted

December 21, 2007

Study Start

August 1, 2007

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

February 2, 2016

Record last verified: 2016-02

Locations

US(1)