OPTIONS Program for Osteoporosis

(OPTIONS Trial)

Not yet recruiting at 1 trial location

Overseen By Patricia Dykes, RN, PhD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Disqualifiers: Non-English/Spanish, No phone, Hospice, Severe cognitive impairment

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 3-12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called OPTIONS (OsteoPorotic FracTure PreventION System) to help older adults recover better after breaking a hip or leg. The trial aims to determine if integrating exercise, a healthy diet, and bone-strengthening medication into care at skilled nursing facilities and at home can improve patients' mobility and quality of life. Participants will come from facilities using special healthcare software and will receive one of two types of care: the full OPTIONS program or the usual care with added fall prevention tips. The trial seeks individuals aged 65 and over who have been admitted to a participating nursing facility and are expected to return home afterward. As an unphased trial, this study offers participants the chance to contribute to innovative care strategies that could enhance recovery and quality of life for many others.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on adding a regimen of exercise, healthy diet, and bone-strengthening medications.

What prior data suggests that the OPTIONS program is safe for older adults?

Research shows that the treatments in the OPTIONS program are generally safe and well-tolerated. Studies indicate that current osteoporosis medications can help build bone or slow bone loss, significantly reducing fractures without major side effects. Specifically, treatments like bisphosphonates and denosumab have lowered fracture risks for years without causing other health problems. These treatments are part of the OPTIONS program, which also includes exercise and dietary advice.

Additionally, combining exercise with medication has helped prevent falls, an important aspect of the program. This approach has improved bone health and reduced fracture risk, with no significant negative effects reported. Overall, the strategies within OPTIONS, focusing on exercise, diet, and medication, have a strong safety record based on previous studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for osteoporosis, which often focus solely on medication, the OPTIONS intervention is unique because it combines clinical decision support with a holistic approach that includes exercise, nutrition, and bone-enhancing medications. This system uses an integrated electronic health record platform to deliver these interventions, ensuring consistent and personalized care in skilled nursing facilities. Researchers are excited about OPTIONS because it not only aims to prevent fractures but also empowers both healthcare providers and patients with tailored strategies to enhance bone health comprehensively.

What evidence suggests that the OPTIONS program is effective for improving recovery after a hip or leg fracture?

Research has shown that a program like OPTIONS, which participants in this trial may receive, includes exercise, healthy eating, and bone-strengthening medication, and can help older adults recover better from fractures. One study found that these activities can lower the risk of breaking the thigh bone, a common issue for people with osteoporosis. Another study showed that starting and continuing osteoporosis medication early can greatly reduce the chance of having another fracture, especially in the hip. These findings suggest that the OPTIONS program could improve bone health and help prevent future fractures in older adults after a hip or leg fracture. Meanwhile, participants in the enhanced usual care arm will have access to the STEADI toolkit, a fall prevention program from the CDC. ^{2 4 6 7 8}

Who Is on the Research Team?

Denise Orwig, PhD

Principal Investigator

University of Maryland, Baltimore

Patricia Dykes, RN, PhD

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

This trial is for older adults who have osteoporosis and have suffered a broken hip or leg. It aims to improve their recovery by testing a program called OPTIONS, which integrates exercise, diet, and bone-strengthening medication into post-fracture care in skilled nursing facilities (SNFs) and after discharge.

Inclusion Criteria

Admitted to a participating SNF

Expected to be discharged back to the community

I am 65 years old or older.

Exclusion Criteria

Do not have access to a working phone

Not in hospice care or no terminal condition (not expected to live at least 4 months)

No severe cognitive impairment (Minimum Data Set 3.0 Cognitive Function Scale (MDS-COGS) score < 5: 0, 1 represents cognitively intact-mild impairment, 2, 3, 4 represents mild-moderate impairment, 5, 6, 7, 8 represents moderate-severe impairment)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the OPTIONS intervention or enhanced usual care in SNFs for rehabilitation

3-12 weeks

In-person visits at SNFs

Follow-up

Participants are monitored for safety and effectiveness after discharge from SNF

12 months

Follow-up assessments at discharge, 6 months, and 12 months post-SNF discharge

Implementation

Implementation of the OPTIONS intervention toolkit and evaluation of adherence during SNF and community care transitions

Pilot phase and trial completion

What Are the Treatments Tested in This Trial?

Interventions

• Enhanced usual care
• OsteoPorotic FracTure PreventION System (OPTIONS)

Trial Overview The study compares the effectiveness of the OPTIONS program with enhanced usual care in SNFs. Enhanced usual care includes standard post-fracture treatment plus information on fall prevention. The goal is to see if OPTIONS can improve physical function and quality of life after discharge.

How Is the Trial Designed?

Group I: OPTIONS intervention Experimental Treatment 1 Intervention

OPTIONS is a multimodal intervention approach that includes providing clinical decision support (CDS) for healthcare providers, patients, and their caregivers focused on exercise, nutrition, and bone-enhancing medications using CDS in SNFs that use the same electronic health record system (PointClickCare).

Group II: Enhanced Usual Care Active Control 1 Intervention

Enhanced usual care includes access to the STEADI (Stopping Elderly Accidents, Deaths, and Injuries) toolkit, a fall prevention program from the CDC.

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Hebrew SeniorLife

Collaborator

Trials

52

Recruited

273,000+

University of Maryland, Baltimore

Collaborator

Trials

729

Recruited

540,000+

University of Florida

Collaborator

Trials

1,428

Recruited

987,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

University of Arkansas

Collaborator

Trials

500

Recruited

153,000+

Published Research Related to This Trial

Preventing osteoporosis-related fractures, especially hip fractures, is crucial as they significantly reduce quality of life and have a high mortality rate, particularly in older adults, with a 51% mortality rate within a year for nonagenarians after a hip fracture.

Effective prevention strategies should start in childhood to build peak bone mass and promote a healthy lifestyle, while also addressing modifiable risk factors like falls, to reduce the increasing prevalence of osteoporotic fractures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk factors and prevention of osteoporosis-related fractures. Dontas, IA., Yiannakopoulos, CK.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4089021/

Osteoporosis Prevention, Screening, and Treatment Recommended measures include sufficient calcium and vitamin D levels, regular weight-bearing exercise, fall prevention, and avoidance of tobacco and excessive ...

2. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2829238

Screening for Osteoporosis to Prevent Fractures: US ... The USPSTF concludes that the evidence is insufficient and the balance of benefits and harms for screening for osteoporosis to prevent ...

3. uspreventiveservicestaskforce.org uspreventiveservicestaskforce.org/uspstf/recommendation/osteoporosis-screening

Osteoporosis to Prevent Fractures: Screening The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for osteoporosis to ...

4. bmcmedicine.biomedcentral.com bmcmedicine.biomedcentral.com/articles/10.1186/s12916-021-02226-8

Effect of an osteoporotic fracture prevention program on ... However, femoral fractures, the most frequent fracture type, were reduced in the intervention group (HR 0.76; 95% CI 0.59–0.99). Mortality and ...

5. link.springer.com link.springer.com/article/10.1007/s00198-025-07687-8

Effectiveness of treatment initiation for secondary fracture ... Early initiation and sustained use of osteoporosis medication significantly reduced the risk of secondary fractures, particularly hip fractures, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9546973/

The clinician's guide to prevention and treatment of osteoporosis Current medications build bone and/or decrease bone breakdown and dramatically reduce incident fractures. All antifracture therapeutics treat but do not cure ...

7. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2829239

Screening for Osteoporosis to Prevent Fractures: A ... Osteoporosis treatment with bisphosphonates or denosumab over several years was associated with fracture reductions and no meaningful increase ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0167494324002346

Priority interventions for the prevention of falls or fractures ... For the prevention of falls in patients with osteoporosis, effective interventions include exercise and exercise plus medication.