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Abaloparatide and pelvic fracture healing: a phase 2 randomized placebo-controlled trial

Nieves, Jeri W; Cosman, Felicia; McMahon, Donald; Berman, Heather; Bartolotta, Roger J; Kazam, J Jacob; Hentschel, Isabelle; Egol, Kenneth; Forsh, David; Zhu, Yuan-Shan; Yoo, Jae Eun; Lane, Joseph
UNLABELLED:Pelvic fractures result in prolonged pain and immobility. In a randomized controlled trial of patients with pelvic fracture, whether abaloparatide (ABL) vs. placebo (PBO) improves healing at 3 months was evaluated. There was no significant difference in CT radiologic healing, physical performance, or change in pain in ABL vs. placebo. PURPOSE/OBJECTIVE:To determine if abaloparatide (ABL) vs. placebo (PBO) improves radiologic healing, pain, and functional outcome at 3 months in patients with pelvic fracture. METHODS:Postmenopausal women and men ≥ 50 years old, enrolled within 4 weeks of pelvic fracture (n = 48), were randomized to blinded ABL vs. PBO. The primary endpoint, fracture healing at 3 months, was assessed by two radiologists using a 5-point scale for cortical bridging from CT images comparing groups by Jonckheere-Terpstra test. The odds of healing (3 or 4 cortices bridged) were analyzed with Mantel-Haenszel relative risks (RR). Pain was assessed monthly by Numeric Rating Scale (NRS). The Short Physical Performance Battery (SPPB; walk speed, chair stands, and balance) evaluated functional mobility. RESULTS:Groups were balanced with a mean age = 82, 93% were female, 98% had multiple rami fractures, 67% had sacral fracture, and 36% had ≥ 1 displaced fracture. CT images at 3 months showed no significant difference in bridging score distribution (indicator of healing) in patients with ABL vs. PBO (p = 0.15) after adjusting for age, sacral fracture, displacement, or compliance. When evaluating individual fractures (n = 81), similar bridging scores were seen with ABL and PBO (p = 0.13). When patients were stratified as healed or not healed, 39% were healed with ABL and 64% healed with PBO (RR 0.61; 95% CI 0.33, 1.12). When looking at the 81 individual fractures, 47% were healed with ABL and 53% healed with PBO (RR = 0.88; 95% CI 0.55, 1.40). Using least square means controlling for age, sacral, and displaced fracture, NRS pain score was higher in the placebo than the ABL group at baseline (p < 0.05), but there were no further group differences in change in pain score SPPB and TUG scores improved over time in both groups without group differences. CONCLUSION/CONCLUSIONS:In this small study, there was no significant difference in CT radiologic healing, physical performance, or change in pain with ABL vs. placebo in patients with acute pelvic fracture. TRIAL REGISTRATION/BACKGROUND:ClinicalTrials.gov identifier: NCT04249232 registered January 27, 2020.
PMID: 42618812
ISSN: 1433-2965
CID: 6071482

Precision Medicine in Atopic Dermatitis: Present and Future

Fonacier, Luz; Mawhirt, Stephanie; Stern, Heather; Roellke, Emma; Singer, Sydney; Hunt, Amanda; Lio, Peter
PMID: 42288255
ISSN: 1534-4436
CID: 6049222

A Curious Case of Hypocalcemia-Induced Seizure From Early Childhood Food Avoidance

Hershberger, Sarah; Bogale, Kaleb; Stern, Heather; Jhaveri, Pooja
PMID: 37974464
ISSN: 2154-1671
CID: 5603072

Persistent Penicillin Allergy Label in Pharmacies after Penicillin Allergy De-labeling [Meeting Abstract]

Diaz, A M; Fonacier, L; Stern, H; Mawhirt, S; Banta, E; Sani, S
Rationale: Carrying a penicillin allergy label is associated with increased healthcare costs and adverse events. De-labeling a penicillin allergy can optimize antimicrobial stewardship and improve patient care.
Method(s): We performed an IRB-approved retrospective study of patients over 11 years-old, who were de-labeled of penicillin allergy (negative skin testing and aminopenicillin oral challenge) in our clinic between May 2019 and May 2022. Patients had their penicillin allergy removed from our electronic medical record (EMR) and were given a wallet card denoting results. A letter with fax confirmation of receipt was sent to both primary care physician and pharmacy. EMR review and phone interviews with patients and pharmacies were subsequently conducted to determine penicillin allergy status and antibiotic prescribing patterns.
Result(s): A total of 78 charts were reviewed: 68 underwent phone interviews, 9 were lost to follow up, and 1 was deceased. From these charts, 77 (99%) remained de-labeled in our EMR, whereas 24 (31%) had an active penicillin allergy listed in their pharmacy. Out of 68 patients interviewed, 66 (97%) recalled a negative penicillin allergy result, 30 (44%) took penicillins since de-labeling, 31 (46%) were not prescribed penicillins, 4 (6%) avoided penicillins, while 3 (4%) reported unknown antibiotic use.
Conclusion(s): This study demonstrates that our pencillin de-labeling protocol is effective in maintaining a non-allergic status and allowing for subsequent penicillin administration. However, the discrepancy in allergy records between our EMR and patients' pharmacies exemplifies the need to identify barriers in universally de-labeling patients.
Copyright
EMBASE:2022489344
ISSN: 1097-6825
CID: 5509742

Needs Assessment for Eosinophilic Esophagitis Education in School Nurses

Bogale, Kaleb; Stern, Heather; Jhaveri, Punit; Jhaveri, Pooja
Over the past 2 decades, eosinophilic esophagitis (EoE) has become increasingly recognized as a common cause of gastrointestinal morbidity in children. A mainstay of treatment is food avoidance, which must be implemented in both the home and school settings for school-aged children. The aim of this study is to assess school nurses' familiarity with EoE with regard to food avoidance and treatment in the school setting. We conducted a 19-question online survey of 60 school nurses (elementary through high school) recruited from Dauphin, Lebanon, and Lancaster Counties in Pennsylvania. Results indicated that 62% of respondents were familiar with EoE. However, only 22% felt comfortable distinguishing between symptoms of EoE and food-dependent anaphylaxis. Almost all respondents (97%) were interested in learning more about EoE. We report significantly increased familiarity with food-dependent anaphylaxis in comparison with EoE among school nurses. There is an interest and need for increasing education on EoE.
PMID: 33438514
ISSN: 1546-8364
CID: 5327992

A Novel RAC2 Variant Presenting as Severe Combined Immunodeficiency [Letter]

Stern, Heather; Donkó, Agnes; Shapiro, Teresa; Hsu, Amy P; Leto, Thomas L; Holland, Steven M; Andreae, Doerthe Adriana
PMID: 33188496
ISSN: 1573-2592
CID: 5327982

Strategies to identify and prevent penicillin allergy mislabeling and appropriately de-label patients

Stern, Heather; Lutzkanin, Kristen; Lutzkanin, Andrew
Taking a good drug allergy history is critical, followed by removing the "penicillin-allergic" label in certain low-risk patients and referring for testing those at high risk.
PMID: 34818164
ISSN: 1533-7294
CID: 5328002

Evaluating Reported Penicillin Allergy in Preteen and Adolescent Females: A Retrospective Study and Quality Improvement Project [Meeting Abstract]

Stern, Heather; Ajewole, Oyindamola; Horwitz, Alexandra
ISI:000517092700171
ISSN: 0091-6749
CID: 5328012

Analysis of Salivary MicroRNAs in Pediatric Eosinophilic Esophagitis [Meeting Abstract]

Lambert, Kristin; Stern, Heather; Ishmael, Faoud; Jhaveri, Punit; Alexander, Chandran; Jhaveri, Pooja
ISI:000517092700131
ISSN: 0091-6749
CID: 5328022

A NOVEL MUTATION IN RAC2 IN AN INFANT WITH COMBINED IMMUNE DEFICIENCY [Meeting Abstract]

Stern, H.; Shapiro, T.; Andreae, D.
ISI:000496175500327
ISSN: 1081-1206
CID: 5328032