Effects of recombinant human parathyroid hormone on the anabolic window and acceleration of lower extremity stress fracture healing

Thesis (M.A.)--Boston UniversityBACKGROUND: Stress fractures are one of the more severe overuse injuries and occur more frequently in women than men. Location and severity of stress fractures vary according to the sport and intensity of physical activity and most commonly involve the lower extremities. The treatment period may extend beyond 12 weeks based on the severity of the stress fracture and physical activity of the patient. Although data are sparse, there is an evolving interest in using systemic medical interventions to potentially improve or accelerate stress fracture repair. Intermittent administration of human recombinant parathyroid hormone (PTH) (1-34) (Teriparatide) is a FDA-approved anabolic treatment used to treat osteoporosis in men and women and reduce fracture risk in postmenopausal women. Although there may be potential benefits of systemic teriparatide therapy to hasten the healing of fractures, there only a few randomized, controlled studies at present. OBJECTIVES: To determine in this randomized, placebo-controlled study whether teriparatide can increase the anabolic window in premenopausal women with lower extremity stress fractures and can hasten the healing process, as assessed by Magnetic Resonance Imaging (MRI). Specifically, we will evaluate: 1) Whether bone formation markers increases more rapidly than resorption markers in response to daily teriparatide (20 μg) at 4 and 8 weeks and of the anabolic window, using the area under the curve between percent changes in biomarkers of formation over resorption over time, and 2) whether there is acceleration of the stress fracture healing, as assessed by MRI images. [TRUNCATED

Short-term effects of teriparatide versus placebo on bone biomarkers, structure, and fracture healing in women with lower-extremity stress fractures: A pilot study

Aims In this pilot, placebo-controlled study, we evaluated whether brief administration of teriparatide (TPTD) in premenopausal women with lower-extremity stress fractures would increase markers of bone formation in advance of bone resorption, improve bone structure, and hasten fracture healing according to magnetic resonance imaging (MRI). Methods: Premenopausal women with acute lower-extremity stress fractures were randomized to injection of TPTD 20-µg subcutaneous (s.c.) (n = 6) or placebo s.c. (n = 7) for 8 weeks. Biomarkers for bone formation N-terminal propeptide of type I procollagen (P1NP) and osteocalcin (OC) and resorption collagen type-1 cross-linked C-telopeptide (CTX) and collagen type 1 cross-linked N-telopeptide (NTX) were measured at baseline, 4 and 8 weeks. The area between the percent change of P1NP and CTX over study duration is defined as the anabolic window. To assess structural changes, peripheral quantitative computed topography (pQCT) was measured at baseline, 8 and 12 weeks at the unaffected tibia and distal radius. The MRI of the affected bone assessed stress fracture healing at baseline and 8 weeks. Results: After 8 weeks of treatment, bone biomarkers P1NP and OC increased more in the TPTD- versus placebo-treated group (both p ≤ 0.01), resulting in a marked anabolic window (p ≤ 0.05). Results from pQCT demonstrated that TPTD-treated women showed a larger cortical area and thickness compared to placebo at the weight bearing tibial site, while placebo-treated women had a greater total tibia and cortical density. No changes at the radial sites were observed between groups. According to MRI, 83.3% of the TPTD- and 57.1% of the placebo-treated group had improved or healed stress fractures (p = 0.18). Conclusions: In this randomized, pilot study, brief administration of TPTD showed anabolic effects that TPTD may help hasten fracture healing in premenopausal women with lower-extremity stress fractures. Larger prospective studies are warranted to determine the effects of TPTD treatment on stress fracture healing in premenopausal women

HIV Prevention and Care Among Black Cisgender Sexual Minority Men and Transgender Women: Protocol for an HIV Status–Neutral Cohort Study Using an Observational-Implementation Hybrid Approach

Background: Black cisgender gay, bisexual, and other sexual minority men (SMM) and transgender women (TW) continue to be heavily affected by HIV. Further research is needed to better understand HIV prevention and care outcomes in this population. In particular, there is a need for research examining the impact of substance use and sleep health on HIV prevention and treatment outcomes among Black SMM and TW. Objective: This paper outlines the study methods being used in the recently launched follow-up study to the Neighborhoods and Networks (N2) study, which we refer to as N2 Part 2 (N2P2). N2P2 aims to address this gap in the literature, build off the findings of the original N2 study, and identify socioenvironmental determinants of health, including whether neighborhood and network factors mediate and moderate these relationships. Methods: Building on the N2 cohort study in Chicago from 2018 to 2022, N2P2 used a prospective longitudinal cohort design and an observational-implementation hybrid approach. With sustained high levels of community engagement, we aim to recruit a new sample of 600 Black SMM and TW participants residing in the Chicago metropolitan statistical area. Participants are asked to participate in 3 study visits across an 18-month study period (1 visit every 9 months). Four different forms of data are collected per wave: (1) an in-person survey, (2) biological specimen collection, (3) a daily remote ecological momentary assessment for 14 days after each study visit, and (4) data from electronic health records. These forms of data collection continue to assess neighborhood and network factors and specifically explore substance use, sleep, immune function, obesity, and the implementation of potential interventions that address relevant constructs (eg, alcohol use and pre-exposure prophylaxis adherence). Results: The N2P2 study was funded in August 2021 by the National Institute of Drug Abuse (R01DA054553 and R21DA053156) and National Heart, Lung, and Blood Institute (R01HL160325). This study was launched in November 2022. Recruitment and enrollment for the first wave of data collection are currently ongoing. Conclusions: The N2P2 study is applying innovative methods to comprehensively explore the impacts of substance use and sleep health on HIV-related outcomes among an HIV status-neutral cohort of Black SMM and TW in Chicago. This study is applying an observational-implementation hybrid design to help us achieve findings that support rapid translation, a critical priority among populations such as Black SMM and TW that experience long-standing inequities with regard to HIV and other health-related outcomes. N2P2 will directly build off the findings that have resulted from the original N2 study among Black SMM and TW in Chicago. These findings provide a better understanding of multilevel (eg, individual, network, and neighborhood) factors that contribute to HIV-related outcomes and viral suppression among Black SMM and TW. International registered report identifier (irrid): DERR1-10.2196/48548.</p

Who can we reach and who can we keep? predictors of intervention engagement and adherence in a cluster randomized controlled trial in South Africa

CITATION: Rabie, S., et al. 2020. Who can we reach and who can we keep? predictors of intervention engagement and adherence in a cluster randomized controlled trial in South Africa. BMC Public Health, 20:275, doi:10.1186/s12889-020-8357-x.The original publication is available at https://bmcemergmed.biomedcentral.comBackground: Engaging and retaining young men in community-based interventions is highly challenging. The purpose of this study was to investigate the individual factors that predict intervention engagement and adherence in a sample of at-risk South African men. Methods: Baseline data were collected as a part of a cluster randomised control trial (RCT) situated in Khayelitsha and Mfuleni, two peri-urban settlements situated on the outskirts of Cape Town, South Africa. Neighbourhoods were randomised to one of three intervention conditions. We performed univariate descriptive statistics to report neighbourhood and individual socio-demographic factors, and ran multivariate models, adjusting for entry of study, to determine if high adherence and consistency of engagement with the intervention were associated with sociobehavioural demographics and risk behaviours, such as hazardous substance use, gangsterism, and criminal activity. Results: Total of 729 men were on average 22.5 years old (SD 2.8), with a mean of 10 years of education. More than half of the sample were single (94%), lived with their parents (66%) and had an income below ~$30 (52%). The overall mean of adherence is 0.41 (SD 0.24) and mean of consistency of engagement is 0.61 (SD 0.30). Our data indicated that completing more years of education, living with parents, and having higher socioeconomic status were significantly associated with higher rates of engagement and adherence. Men with a history of gang membership demonstrated higher levels of adherence and consistent engagement with the intervention, compared with other men who were recruited to the intervention. Crucially, our data show that young men with a history of substance use, and young men who report symptoms of depression and high levels of perceived stress are equally likely as other young men to adhere to the intervention and attend intervention sessions consistently. Conclusion: Our results may contribute to a better understanding of young men’s patterns of engagement and adherence to public health interventions. The results may have important implications for policy and practice, as they may be useful in planning more effective interventions and could potentially be used to predict which young men can be reached through community-based interventions.https://bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-020-8357-xPublisher's versio

Sexual Assault Nurse Examiners Lead to Improved Uptake of Services: A Cross-Sectional Study

Introduction: Sexual Assault Nurse Examiners (SANE), who are trained to provide comprehensive and compassionate specialty care to sexual assault survivors, are increasingly used in the emergency department (ED), but there is little published literature to support their benefit. In this study we aimed to compare services offered and received by sexual assault survivors in the ED when care was provided by a SANE vs those with traditional care teams, hypothesizing that SANE utilization will be associated with improved uptake of recommended services.Methods: This was a retrospective review examining all patient encounters in which a sexual assault was disclosed in a large, urban, adult ED between June 1, 2019–June 30, 2022. We extracted timeline information from the ED encounter, demographic information, resources offered to and accepted by the patient, clinical care data, and continuity of care data from the medical record. We used unadjusted and adjusted analyses to compare patient demographics and services offered and accepted between SANE and non-SANE encounters.Results: We included a total of 182 encounters in the analysis, of which 130 (71.4%) involved SANEs. Demographics were similar between groups, except there was a larger proportion of cisgender men in the non-SANE group (14.0% vs 5.5%), and the timing of visits differed, with non-SANE visits more common during the overnight shift. All recommended testing, prophylaxis, and resources were offered more frequently during SANE visits, and all but one were more frequently accepted by patients during SANE visits, although not all comparisons reached statistical significance.Conclusion: Patients who received care from a SANE were more often offered recommended services and resources and more frequently accepted them. Making SANE care available at all times to these vulnerable patients would both improve patient outcomes and allow hospitals to meet required quality metrics. States should consider expanding legislation to encourage and fund SANE coverage for all hospitals to support access to vital resources in the ED for survivors of sexual assault

Who can we reach and who can we keep? Predictors of intervention engagement and adherence in a cluster randomized controlled trial in South Africa.

BackgroundEngaging and retaining young men in community-based interventions is highly challenging. The purpose of this study was to investigate the individual factors that predict intervention engagement and adherence in a sample of at-risk South African men.MethodsBaseline data were collected as a part of a cluster randomised control trial (RCT) situated in Khayelitsha and Mfuleni, two peri-urban settlements situated on the outskirts of Cape Town, South Africa. Neighbourhoods were randomised to one of three intervention conditions. We performed univariate descriptive statistics to report neighbourhood and individual socio-demographic factors, and ran multivariate models, adjusting for entry of study, to determine if high adherence and consistency of engagement with the intervention were associated with socio-behavioural demographics and risk behaviours, such as hazardous substance use, gangsterism, and criminal activity.ResultsTotal of 729 men were on average 22.5 years old (SD 2.8), with a mean of 10 years of education. More than half of the sample were single (94%), lived with their parents (66%) and had an income below ~$30 (52%). The overall mean of adherence is 0.41 (SD 0.24) and mean of consistency of engagement is 0.61 (SD 0.30). Our data indicated that completing more years of education, living with parents, and having higher socioeconomic status were significantly associated with higher rates of engagement and adherence. Men with a history of gang membership demonstrated higher levels of adherence and consistent engagement with the intervention, compared with other men who were recruited to the intervention. Crucially, our data show that young men with a history of substance use, and young men who report symptoms of depression and high levels of perceived stress are equally likely as other young men to adhere to the intervention and attend intervention sessions consistently.ConclusionOur results may contribute to a better understanding of young men's patterns of engagement and adherence to public health interventions. The results may have important implications for policy and practice, as they may be useful in planning more effective interventions and could potentially be used to predict which young men can be reached through community-based interventions.Trial registrationClinicalTrials.gov registration, NCT02358226. Prospectively registered 24 November 2014

Identifying fetal alcohol spectrum disorder among South African children at aged 1 and 5 years

BackgroundFetal Alcohol Spectrum Disorders (FASD) are a global health concern. Early intervention mitigates deficits, yet early diagnosis remains challenging. We examined whether children can be screened and meet diagnoses for FASD at 1.5 years compared to 5 years post-birth.MethodsA population cohort of pregnant women in 24 neighborhoods (N = 1258) was recruited and 84.5 %-96 % were reassessed at two weeks post-birth, 0.5 years, 1.5 years, 3 years, and 5 years later. A two-step process was followed to diagnose FASD; first, a paraprofessional screened the children and then a physician evaluated the child. We evaluated FASD symptoms at 1.5 vs. 5 years. We also examined maternal differences in children receiving a positive FASD screening (n = 160) with those who received a negative FASD screening.ResultsScreening positive for FASD more than doubled from 1.5 years to 5 years (from 6.8 % to 14.8 %). About one quarter of children who screened positive and were evaluated by a physician, were diagnosed as having a FASD. However, half did not complete the 2nd stage screening. Compared to mothers of children with a negative FASD screening, mothers of children with a positive FASD screening were less likely to have a high school education and more likely to have lower incomes, have experienced interpersonal partner violence, and have a depressed mood. Mothers of children who did not follow up for a 2nd stage physician evaluation were more like to live in informal housing compared to those who followed-up (81.3 % vs. 62.5 %, p = 0.014).ConclusionsWe found that children can be screened and diagnosed for FASD at 1.5 and 5 years. As FASD characteristics develop over time, repeated screenings are necessary to identify all affected children and launch preventive interventions. Referrals for children to see a physician to confirm diagnosis and link children to care remains a challenge. Integration with the primary healthcare system might mitigate some of those difficulties

Identifying fetal alcohol spectrum disorder among South African children at aged 1 and 5 years.

BackgroundFetal Alcohol Spectrum Disorders (FASD) are a global health concern. Early intervention mitigates deficits, yet early diagnosis remains challenging. We examined whether children can be screened and meet diagnoses for FASD at 1.5 years compared to 5 years post-birth.MethodsA population cohort of pregnant women in 24 neighborhoods (N = 1258) was recruited and 84.5 %-96 % were reassessed at two weeks post-birth, 0.5 years, 1.5 years, 3 years, and 5 years later. A two-step process was followed to diagnose FASD; first, a paraprofessional screened the children and then a physician evaluated the child. We evaluated FASD symptoms at 1.5 vs. 5 years. We also examined maternal differences in children receiving a positive FASD screening (n = 160) with those who received a negative FASD screening.ResultsScreening positive for FASD more than doubled from 1.5 years to 5 years (from 6.8 % to 14.8 %). About one quarter of children who screened positive and were evaluated by a physician, were diagnosed as having a FASD. However, half did not complete the 2nd stage screening. Compared to mothers of children with a negative FASD screening, mothers of children with a positive FASD screening were less likely to have a high school education and more likely to have lower incomes, have experienced interpersonal partner violence, and have a depressed mood. Mothers of children who did not follow up for a 2nd stage physician evaluation were more like to live in informal housing compared to those who followed-up (81.3 % vs. 62.5 %, p = 0.014).ConclusionsWe found that children can be screened and diagnosed for FASD at 1.5 and 5 years. As FASD characteristics develop over time, repeated screenings are necessary to identify all affected children and launch preventive interventions. Referrals for children to see a physician to confirm diagnosis and link children to care remains a challenge. Integration with the primary healthcare system might mitigate some of those difficulties