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OPTIONS Research Study for Osteoporosis and Lower Limb Fractures

This study, called OPTIONS, is looking at ways to help people aged 65 and older who have broken a bone in their leg or hip due to osteoporosis (a disease that weakens bones). It tests a program called OPTIONS (OsteoPorotic fracTure preventION System), which helps healthcare providers, patients, and their caregivers with exercise, nutrition, and bone-strengthening medications. This is compared to "Enhanced usual care," which includes a fall prevention program from the CDC. The goal is to see if the OPTIONS program can improve your ability to function and your quality of life after leaving a skilled nursing facility (SNF). You may be able to join if you are 65 or older, lived at home before your fracture, and are going to a SNF for rehabilitation after breaking a lower limb bone. The study is currently unclear on its recruitment status and plans to enroll 1344 participants.

Study design
This interventional study plans to enroll 1344 participants aged 65 and older. It compares the OPTIONS program to enhanced usual care.
What's involved
Patient-reported function and quality of life will be measured at discharge from a skilled nursing facility (within four weeks) and at six and twelve months after discharge.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for twelve months after discharge from a skilled nursing facility.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06731608

OsteoPorotic fracTure preventION System (OPTIONS) Research Study

Recruiting
NAAges 65+InterventionalPrevention
Brigham and Women's Hospital
~1,344 participants
Updated 2026-01-29 on ClinicalTrials.gov
What's tested:OPTIONSEnhanced usual care

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Patient-reported function
Measured over Discharge from a SNF within four weeks and at six months and twelve months post-SNF discharge (three-time points)
+1 more outcome measured

Conditions

Osteoporosis
Lower Limb Fracture

Explore related trials

Lower Extremity FractureOsteoporosis

Where it's being run

2 sites across 2 states
Maryland1
Massachusetts1

Study leadership

  • Denise Orwig, PhD · PRINCIPAL_INVESTIGATOR · University of Maryland, Baltimore
  • Patricia Dykes, RN, PhD · PRINCIPAL_INVESTIGATOR · Brigham and Women's Hospital

Who to contact

Patricia Dykes, RN, PhD
[email protected]
617-850-5748
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age ≥65 years old
Community-dwelling at the time of fracture
Admission to a participating SNF for rehabilitation following a lower limb fragility fracture, including pelvic fractures
Expected discharge to the community (home or assisted living)

Exclusion

Not English or Spanish speaker
Admission Brief Interview for Mental Status (BIMS) score 0-7
SNF length of stay \< 7 days
Regular access to a working telephone or other communication device
Receiving hospice or end-of-life care

What this trial measures

  • Patient-reported functionDischarge from a SNF within four weeks and at six months and twelve months post-SNF discharge (three-time points)

    Daily Activity Scale of the Activity Measure for Post-Acute Care (AM-PAC) Daily Activity Outpatient Short Form (Low Function): The AM-PAC measures a patient's functional ability to perform daily activities, with higher scores indicating greater independence (raw scores range from 6 to 24).

  • Patient-reported quality of lifeDischarge from a SNF within four weeks and at six months and twelve months post-SNF discharge (three-time points)

    Euroqol-5-Dimension Questionnaire-3-Level (EQ-5D-3L): The EQ-5D-3L measures health-related quality of life (Mobility, Self-care, Usual activities, Pain or discomfort, and Anxiety or depression). The best possible health state is represented by score of 1, and the worst possible health state is less than 0.