Activity

Achievement of 5-10% weight loss (WL) among older adults living with obesity considerably improves prognosis of health-related outcomes; however, concomitant declines in bone mineral density (BMD) limit overall benefit by increasing fracture risk. Declines in mechanical loading contribute to WL-associated BMD loss, with pilot data signaling the addition of external weight replacement (via weighted vest use) during intentional WL mitigates bone loss at weight bearing sites to a similar degree as resistance exercise training (RT). Definitive data in support of weighted vest use as a potential strategy to mitigate WL-associated bone loss in this population are needed.

In the Incorporating Nutrition, Vests, Education, and Strength Training (INVEST) in Bone Health trial (NCT04076618), 192 older adults (60-85years) who are overweight (BMI≥27kg/m

) with at least one obesity-related risk factor or obese (BMI=30-40kg/m

) will be randomly assigned to participate in one of three 12-month intervention groups WL alon to minimize bone loss during intentional WL among older adults with obesity.The National Institutes of Health (NIH) and the National Institute of Mental Health (NIMH) have implemented numerous clinical trial policies in recent years. These policies have well-intended goals but concerns of undue burden have been raised by professional societies. This study identified the new and revised NIH and NIMH clinical trial policies from 2005 to 2019 and summarized the publicly-identified potential benefits and burdens of those policies. Five new/revised NIH-wide and four NIMH-only clinical trial policies were identified. Potential benefits were improved identification, review, conduct, and reporting of publicly-funded clinical trials. Potential burdens were loss of researcher time, potential loss of future research funding opportunities for basic behavioral researchers, and researcher confusion resulting from perceived definition overlap between clinical trials and basic science. Future clinical trial policy development may benefit from early engagement of researchers as stakeholders. Policymakers may benefit from publicly incorporating benefit/burden analyses and outcome evaluations into future policy development.

Retrospective studies have shown that angiotensin-converting-enzyme (ACE) inhibitors are associated with a reduced risk of complications and mortality in persons with novel coronavirus disease 2019 (COVID-19). Thus, we aimed to examine the efficacy of ramipril, an ACE-inhibitor, in preventing ICU admission, mechanical ventilation and/or mortality while also minimizing the risk of transmission and use of personal protective equipment (PPE).

RAMIC is a multicenter, randomized, double-blind, allocation-concealed, placebo-controlled trial comparing the efficacy of treatment with ramipril 2.5mg orally daily compared to placebo for 14days. The study population includes adult patients with COVID-19 who were admitted to a hospital or assessed in an emergency department or ambulatory clinic. Key exclusion criteria include ICU admission or need for mechanical ventilation at screening, use of an ACE inhibitor or angiotensin-receptor-II blocker within 7days, glomerular filtration rate<40mL/min or a systolic blood pressure (BP)<100mmHg or diastolic BP<65mmHg. Patients are randomized 21 to receive ramipril (2.5mg) or placebo daily. Informed consent and study visits occur virtually to minimize the risk of SARS-CoV-2 transmission and preserve PPE. The primary composite endpoint of ICU admission, invasive mechanical ventilation and death are adjudicated virtually.

RAMIC is designed to assess the efficacy of treatment with ramipril for 14days to decrease ICU admission, mechanical ventilator use and mortality in patients with COVID-19 and leverages virtual study visits and endpoint adjudication to mitigate risk of infection and to preserve PPE (ClinicalTrials.gov, NCT04366050).

RAMIC is designed to assess the efficacy of treatment with ramipril for 14 days to decrease ICU admission, mechanical ventilator use and mortality in patients with COVID-19 and leverages virtual study visits and endpoint adjudication to mitigate risk of infection and to preserve PPE (ClinicalTrials.gov, NCT04366050).

People with opioid use disorder (OUD) often have a co-occurring psychiatric disorder, which elevates the risk of morbidity and mortality. Promising evidence supports the use of collaborative care for treating people with OUD in primary care. Whether collaborative care interventions that treat both OUD and psychiatric disorders will result in better outcomes is presently unknown.

The Whole Health Study is a 3-arm randomized controlled trial designed to test collaborative care treatment for OUD and the psychiatric disorders that commonly accompany OUD. Approximately 1200 primary care patients aged ≥18years with OUD and depression, anxiety, or PTSD will be randomized to one of three conditions (1) Augmented Usual Care, which consists of a primary care physician (PCP) waivered to prescribe buprenorphine and an addiction psychiatrist to consult on medication-assisted treatment; (2) Collaborative Care, which consists of a waivered PCP, a mental health care manager trained in psychosocial treatments for OUD and psychiatric disorders, and an addiction psychiatrist who provides consultation for OUD and mental health; or (3) Collaborative Care Plus, which consists of all the elements of the Collaborative Care arm plus a Certified Recovery Specialist to help with treatment engagement and retention. Primary outcomes are six-month rates of opioid use and six-month rates of remission of co-occurring psychiatric disorders.

The Whole Health Study will investigate whether collaborative care models that address OUD and co-occurring depression, anxiety, or PTSD will result in better patient outcomes. The results will inform clinical care delivery during the current opioid crisis.

http://www.clinicaltrials.gov registration NCT04245423.

http://www.clinicaltrials.gov registration NCT04245423.

To compare the efficacy of denosumab and alendronate on raising spine bone mineral density (BMD) in long-term glucocorticoid (GC) users.

Adult patients receiving long-term prednisolone (≥2.5mg/day for ≥1year) were recruited and randomized to either subcutaneous denosumab (60mg/6months) or oral alendronate (70mg/week). BMD (lumbar spine, femoral neck, hip) and bone markers (serum P1NP and CTX) were measured at month 0, 6 and 12. The difference in spine BMD (primary outcome) at month 12 was compared between the two groups.

139 subjects were recruited (age 50.0±12.7years; 96% women) 69 assigned denosumab and 70 assigned alendronate. selleck kinase inhibitor At entry, 73(53%) patients were osteoporotic and 82(59%) patients were naive to the bisphosphonates. Baseline clinical characteristics and BMD values were similar in the two groups. At month 12, a significant gain in mean BMD at the lumbar spine (+3.5±2.5%; p<0.001), hip (+0.9±2.8%; p=0.01) and femoral neck (+1.04±4.1%; p=0.047); was observed in denosumab-treated patients, whereas the corresponding change was +2.