65 and older, any sex, with Fractures, Bone. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants Experiencing Fragility Fractures and Serious Fall-Related Injuries (FF/SFI)Primary· 36 months
Every 4 months the investigators will call the participants asking questions about the main outcome, FF/SFI. A fall calendar will be given to the participant to record all fall events (e.g., date, location). This will help participants to recall falls during the 4 month period. In addition, this will allow medical records to be requested, using a signed authorization form (part of the consent form). The investigators will review all relevant Electronic Health Records (EHR) information, such as hospital and emergency department discharge summaries, outpatient visit notes, consultation notes, ph
Group
Value
95% CI
Enhanced Usual Care - Control Group
186
Enhanced Usual Care Plus Exercise Coaching Intervention
166
Number of Falls and Falls-related Injuries Using the Behavioral Risk Factor Surveillance System (BRFSS)Secondary· 36 months
The investigators will examine the number of falls, and fall-related injuries using two questions from the BRFSS.
Group
Value
95% CI
Enhanced Usual Care - Control Group
0.87
0.79 – 0.95
Enhanced Usual Care Plus Exercise Coaching Intervention
0.84
0.76 – 0.93
Percentage of Participants With Excellent/Very Good Health Using the Patient Reported Outcomes Measurement Information System (PROMIS)Secondary· 36 months
The investigators will use a self-reported health question to assess key patient centered outcomes that the intervention may improve. This question is from the NIH-supported PROMIS. The outcome is categorized as excellent/very good health vs. good/fair/poor health as reported on the single question.
Group
Value
95% CI
Enhanced Usual Care - Control Group
52.2
Enhanced Usual Care Plus Exercise Coaching Intervention
54.3
Assessment of Fear of Falling Using the Falls Efficacy Scale International (FES-I)Secondary· 36 months
The investigators will use the 7-item version of the Falls Efficacy Scale International (FES-I), used to quantify fear of falling in 7 different scenarios. Each item is scored 1-4, with higher scores being associated with greater fear. Total sum score is reported, possible range 7-28.
Group
Value
95% CI
Enhanced Usual Care - Control Group
11.65
10.96 – 12.33
Enhanced Usual Care Plus Exercise Coaching Intervention
11.11
10.45 – 11.77
Percentage of Participants Meeting Physical Activity Guidelines Using the National Health Interview Survey (NHIS)Secondary· 36 months
The investigators will use 6 questions from the NHIS at baseline and the 36 month follow-up to measure participants' activity level. Percentage of participants with a sum of moderate and vigorous minutes \>=150 is reported.
Group
Value
95% CI
Enhanced Usual Care - Control Group
50.7
Enhanced Usual Care Plus Exercise Coaching Intervention
50.9
Assessment of Physical Function Using PROMISSecondary· 36 months
The investigators will use 4 physical function questions to assess physical function subscale of PROMIS. Each item ranges 1-5. Total sum score is reported; higher scores are associated with lower levels of physical function. Total sum score range, 4-20.
Group
Value
95% CI
Enhanced Usual Care - Control Group
9.00
8.28 – 9.72
Enhanced Usual Care Plus Exercise Coaching Intervention
8.77
8.08 – 9.47
Assessment of Depression Using PROMISSecondary· 36 months
The investigators will use 4 depression questions to assess key patient centered outcomes that the intervention may improve. These questions are from the NIH-supported PROMIS.
Group
Value
95% CI
Enhanced Usual Care - Control Group
5.62
5.21 – 6.03
Enhanced Usual Care Plus Exercise Coaching Intervention
5.52
5.12 – 5.91
Assessment of Anxiety Using PROMISSecondary· 36 months
The investigators will use 4 anxiety questions to assess key patient centered outcomes that the intervention may improve. These questions are from the NIH-supported PROMIS.
Group
Value
95% CI
Enhanced Usual Care - Control Group
6.21
5.79 – 6.64
Enhanced Usual Care Plus Exercise Coaching Intervention
6.07
5.66 – 6.48
Assessment of Loneliness Using PROMISSecondary· 36 months
The investigators will use 3 loneliness questions to assess key patient centered outcomes that the intervention may improve. These questions are from the NIH-supported PROMIS.
Group
Value
95% CI
Enhanced Usual Care - Control Group
4.19
3.92 – 4.46
Enhanced Usual Care Plus Exercise Coaching Intervention
4.12
3.86 – 4.38
Adverse events — posted to ClinicalTrials.gov
Time frame: Data were collected every 4 months for the full 36-month duration of study participation..
Reporting threshold: 0.5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Enhanced Usual Care - Control Group
Serious: 162/569 (28%)
Deaths: 22/569
Enhanced Usual Care Plus Exercise Coaching Intervention
The investigators propose a 36-month multi-center randomized effectiveness trial to compare the impact of an Enhanced Usual Care (Control) intervention, with Exercise Coaching (Exercise), on Fragility Fractures and Serious Fall-Related Injuries (FF/SFRI) in patients with a previous fragility fracture (FF).
The investigators will also examine the impact of the intervention on several secondary outcomes like: loneliness, physical function, and bone strength. The investigators will do this by following a Pragmatic trial design: 1) limiting exclusions to increase representativeness, 2) limiting research contacts (average 30 min/year) and 3) limiting measures to those practicable for use in usual care.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Milton S. Hershey Medical Center
Last refreshed: 5 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02714257.