Comparative Effectiveness of Multimodal Interventions to Prevent Osteoporotic Fractures -– Cycle 3 2022

Notice of Upcoming PCORI Funding Announcement
The Patient-Centered Outcomes Research Institute (PCORI) intends to reissue a Targeted PCORI Funding Announcement on September 7, 2022, seeking to fund high-quality, comparative clinical effectiveness research (CER) projects that focus on multimodal interventions to prevent fractures in people with osteoporosis and a history of a fracture. This preannouncement is provided to allow potential applicants additional time to identify collaborators; obtain stakeholder input on potential studies; and develop responsive, high-quality proposals.

Research Initiative Highlights
Fracture is a significant consequence from osteoporosis with estimates of one in two women and up to one in four men experiencing a fracture in their lifetime due to osteoporosis, which translates to about 2 million people affected annually. Consequences of osteoporotic-related fractures include significant mortality and morbidity, with decreases in functional independence, quality of life, and ability to live in the community. Another consequence of fracture is a subsequent fracture, with about 10 percent refracturing within 1 year and 30 percent within 5 years.

Osteoporosis treatment is multimodal and includes drug therapies and nonpharmacological interventions. While evidence exists for single interventions, broad evidence gaps exist around multimodal interventions to prevent second fractures and stakeholders have identified more research as a priority.

This Targeted PCORI Funding Announcement will solicit applications that respond to the following question:

What is the comparative effectiveness of multimodal treatment interventions (i.e., combination of pharmacologic and/or non-pharmacologic) on patient-centered outcomes in people with osteoporosis and a history of fractures?

Proposed studies should compare the effectiveness of pharmacological and/or nonpharmacological combination interventions. PCORI is interested in comparing combinations and/or sequences of interventions that are either in common use, have suggested efficacy, or have strong theoretical underpinnings. Regardless, proposed combinations or sequences of interventions should address actual clinical choices or dilemmas faced by patients, caregivers, and clinicians in specific practice settings.

Studies should focus on postmenopausal women and on men with osteoporosis and a history of fracture. Underrepresented groups from previous studies (e.g., men and women in racial/ethnic groups other than Caucasian) are of particular interest.

Applicants should consider the following outcomes: fractures, validated measures of pain and functional status, functional independence, institutionalization, quality of life, and other outcomes important to clinician and patient shared decision making.

Length of follow-up should be determined based on appropriateness for the intervention/design up to a maximum of four years for fracture outcomes; other outcomes may have a shorter follow-up.

For questions regarding this funding announcement, please reach out to sciencequestions@pcori.org.

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