Adiposity
Age Gene/Environment Susceptibility-Reykjavik-Bone Marrow Adiposity Study
This study is an ongoing population-based study of older men and women in Iceland. It was initiated to examine genetic susceptibility and gene/environment interaction as these contribute to phenotypes common in old age. AGES-Bone Marrow Adiposity Study is sponsored by NIAMS to determine the correlation of marrow adiposity with bone markers and other body composition parameters, such as bone density, body fat mass, visceral and subcutaneous adipose tissue, and fatty muscle infiltration.
Principal Investigator: Ann V. Schwartz, PhD, MPH
Project Director: Trisha F. Hue, PhD, MPH
Research Area: Bone, Adiposity
Status: Completed
AFF
Atypical Femoral Fractures: A Population-Based Study of Risk Factors and Relationship to Bisphosphonate Exposure and Discontinuation)(AFF)
Dr. Doug Bauer, a UCSF General Internist and SFCC member for over 25 years, recently received an NIH grant to study the long-term effects of bisphosphonates, particularly the occurrence of atypical femoral fractures (AFF) which appear to be more common after prolonged bisphosphonate use. Along with UCSF Biostatistician Dennis Black and a Danish collaborator, he plans to analyse longitudinal pharmacy and fracture data from Denmark dating back to 1995. Dr. Bauer hopes to determine how the duration of bisphosphonate use and other risk factors, and discontinuation of bisphosphonates, relates to the risk of AFF in the Danish population.
Principal Investigator: Douglas C. Bauer, MD
Research Area: Bone
Status: Completed
CALERIE
Comprehensive Assessment of Long-term Effects of Reducing Intake of Energy
This study is a multi-center, parallel-group, randomized, controlled trial that's overall aim is to test the hypothesis that two years of sustained caloric restriction will slow aging and protect against age-related disease processes. UCSF is providing DXA Quality Assurance. BMD at the hip, spine and wrist, as well as composition of the total body are measured for the study, and UCSF is centrally analyzing and archiving all scans.
Principal Investigator: Ann V. Schwartz, PhD, MPH
Research Area: Aging/Longevity, Bone
Status: Completed
CARGO
Comprehensive Evaluation of Aging-Related Clinical Outcomes and Geroproteins (CARGO)
Our study harnesses the comprehensive data and statistical power of the Cardiovascular Health Study (CHS) and Dynamics of Health and Body Composition Study (Health ABC) to analyze whether proteins discovered to delay or accelerate aging in the brain, heart, and skeletal muscle are associated with important clinical outcomes: dementia, heart failure, and mobility disability. Data and specimens from the Baltimore Longitudinal Study of Aging (BLSA) will enable us to understand how these proteins vary with age and influence the brain,heart and muscle across the life span. This study will provide a comprehensive picture of the potential of these proteins to give rise to new treatments for major causes of aging-related disability and mortality.
Principal Investigator: Steven R.Cummings, MD
Project Director: Robin Collins, MPH
Research Area: Aging/Longevity
Status: Completed
COZI
Comparative Effectiveness of Zolpidem and Cognitive Behavioral Therapy for Insomnia in Rural Adults (COZI)
Insomnia is a common health problem that causes distress, impaired function, and increased risk for other health problems. Chronic insomnia is defined by problems with the quality or amount of sleep, including difficulty falling asleep, frequent awakenings, and/or awakening early and being unable to return to sleep. In developing this application, patients, providers, payors, and the investigators identified both concerns and opportunities with current treatments for chronic insomnia. Medications and Cognitive Behavioral therapy for insomnia (CBT-I; a treatment program to improve sleep through changes in behavior and thinking) are both effective for treating insomnia. Zolpidem, the most frequently prescribed insomnia medication, is widely available, but may cause side effects and dependency. CBT-I is the recommended first line treatment by many professional organizations, but it is not widely available in physicians’ practices. Patients, providers, and payors face important unanswered questions: Which treatment should be used for the treatment of chronic insomnia? Is combination therapy more effective, and does it result in lower zolpidem use? Who responds best to which treatment? These dilemmas are particularly relevant to patients and providers in rural areas, where access to behavioral health specialists is limited, and concerns regarding use of controlled substances is particularly acute. COZI will address these questions.
Principal Investigator: Katie L. Stone, PhD (Dual PI: Daniel J. Buysse)
Project Director: Robin Collins, MPH
Research Area: Aging/Longevity, Sleep, Cognitive function
Status: Ongoing
Creatine Dilution
Determination of Skeletal Muscle Mass by Creatine Dilution
A novel measure of total body skeletal muscle mass is the creatine dilution method. Briefly, the total creatine pool size, and thus total body skeletal muscle mass, can be estimated by orally dosing individuals with deuterated creatine (d3-creatine) and then subsequently measuring labeled creatinine (d3-creatinine) in a single urine sample. We posit that total body skeletal muscle mass as measured by this method is related to strength and physical performance, and that individuals with decreased total body skeletal muscle mass will have an increased risk of falls, fractures and functional impairments. We use traditional methods such as receiver-operator curves, and newer approaches including the net reclassification index and predictiveness curves, to investigate whether total body skeletal muscle mass as determined by the creatine dilution method is superior to appendicular lean mass (from DXA), age, BMI and strength in predicting the risk of falls, fractures, mortality and mobility limitationin older men. We plan to efficiently test these hypotheses via an ancillary study to the ongoing Osteoporotic Fractures in Men (MrOS) study - a large, well-characterized, prospective, multicenter study. We propose to add this measure to the already funded study Visit 4. Should our hypotheses prove correct, the creatine dilution method for assessing total body skeletal muscle mass would become a critical research tool used to elucidate the pathophysiology of sarcopenia. By providing a highly precise method to monitor response, the creatine dilution method will aid the development of novel agents for reversing age-related muscle loss. This simple test could be used clinically as an alternative to DXA to identify men at risk of physical decline and to refine sarcopenia definitions.
Principal Investigator: Peggy M. Cawthon, PhD
Research Area: Aging Muscle
Status: Completed
D3-creatine
Evaluating D3-creatine dilution estimates of muscle mass due to weight loss and exercise in older adults who have obesity
This study will evaluate the impact of weight loss resulting from caloric restriction (with or without exercise) on muscle mass in older adults with obesity. Muscle mass will be measured with the new D3-creatine method. We will also determine whether the change in muscle mass is related to the change in physical performance that accompanies weight change.
Principal Investigator: Peggy M. Cawthon, PhD
Research Area: Aging Muscle
Status: Completed
ESSENTIAL
Effects of Successful OSA Treatment on Memory and AD BIomarkers in Older AduLts (ESSENTIAL)
The prevalence of Alzheimer disease (AD) is high and projected to increase. Further, epidemiological data suggests that ~15% of AD risk may be attributed to sleep problems. Obstructive sleep apnea (OSA) is also common among the elderly (30-55%), and our prior work has established that cognitively normal older women with OSA have nearly double the 5-year risk of developing mild cognitive impairment (MCI) or dementia. Further, we showed that: i. OSA patients treated with positive airway pressure (PAP) experienced significant overnight increases in plasma neurofilament light (NfL), a marker of neural injury, with strong trends for AD specific biomarkers (i.e. Aβ40 and Tau) after PAP withdrawal; ii. OSA predicted longitudinal increases in AD biomarkers; and, iii. PAP treatment delayed the onset of MCI in subjects with reported OSA. There is therefore strong evidence suggesting that OSA treatment could be an important prevention strategy for AD. However,trials for treatment of OSA to slow cognitive decline and progression to AD face a number of challenges. First, the most effective therapy (PAP) has poor adherence. A second challenge is defining the target population: prior trials targeted OSA patients with MCI/AD, who have more advanced disease and could be less amenableto treatment. A third challenge is identifying cognitive testing that is sensitive to sleep disruption, and linked to increased AD risk. (To capture effects of OSA on the offline processing phase requires sleep-dependent memory paradigms, in which the encoding and recall of information are separated by a period of sleep with/without OSA). Finally, a randomized trial of sufficient duration to test the effects of treatment of OSA on risk of incident AD is not feasible. Our proposed trial, Effects of Successful OSA TreatmENT on Memory and AD BIomarkers in Older AduLts (ESSENTIAL), addresses these challenges. ESSENTIAL is a 5-year study of cognitively normal older adults with newly diagnosed OSA, ages 55-75, recruited from 4 well-established sleep clinics. OSA patients (n=200) will be randomized to either: i) a 3-month OSA treatment by any combination of PAP, OAT, and positional therapy that results in an “effective” improvement in the apnea-hypopnea index (AHI); ii) a waitlist control group to receive treatment at the conclusion of the 3-month intervention period. Effectively treated individuals (~150) and untreated individuals (~100) will then be followed for up to 24 months to compare whether sustained improvements in AHI are associated with better cognitive function and AD biomarker change profiles as compared to untreated controls. Participants will undergo PSG, actigraphy, cognitive tests, and blood draws at baseline, 3 and 24 months. Our aims are: 1) To compare 3-month change in plasma AD biomarkers (NfL, p-tau, Aβ) between those randomized to OSA treatment and wait-list control groups; 2) To compare 3-month change in cognition between the OSA treatment and wait-list control groups; 3) To examine if sustained reduction in AHI over 24 months among effectively treated participants versus untreated controls is associated with better 24-month change profiles for AD biomarkers and cognition..
Principal Investigator: Katie L. Stone, PhD
Research Area: Aging/Longevity, Sleep, Cognitive function
Status: Ongoing
FLEX
FIT Long-Term Extension
This study assesses the effects of continuing alendronate beyond 5 years. Postmenopausal women (N=1,099) who had previously been randomized to alendronate in FIT (Fracture Intervention Trial) were randomized to 5 years of continued alendronate.
Principal Investigator: Dennis M. Black, PhD
Research Area: Osteoporosis
Status: Completed
FREEDOM
Fracture Reduction and Evaluation of Denosumab in Osteoporosis every 6 Months
In this phase III trial, the Coordinating Center was responsible for adjudication of cardiovascular events and deaths and leadership and management of the Steering and Publication Committees. The trial involved over 7,000 participants at 350 sites.
Principal Investigator: Steven R. Cummings, MD
Project Director: Dana Kriesel, MPH
Research Area: Bone, Osteoporosis
Status: Completed
HABC
Health, Aging, and Body Composition Study
This observational study looks at the onset of physical disability in relation to body composition change, particularly loss of muscle mass in old age. The study began in 1996, has two sites, and over 3,000 participants.
Principal Investigators: Steven R. Cummings, MD, Michael C. Nevitt, PhD, MPH
Project Director: Susan M. Rubin, MPH
Research Area: Aging/Longevity, Muscle
Status: Completed
HORIZON-PFT/Extension
Health Outcomes & Reduced Incidence with Zoledronic Acid Trial
The initial study was a phase III, 3-year international, multi-center, randomized control trial of over 7,000 postmenopausal women in 27 countries for the treatment of osteoporosis and other health outcomes with yearly zolendronic acid versus placebo. Extension 1 is a 3-year extension to look at outcomes such as fracture, bone mineral density, and other adverse events after 6 years. Extension 2 is a 3-year extension of Extension 2 and includes continued treatment and monitoring of outcomes after 9 years.
Principal Investigator: Dennis M. Black, PhD
Project Director: Trisha F. Hue, PhD, MPH
Research Area: Bone, Osteoporosis
Status: Completed
Longevity Consortium
The Longevity Consortium (LC) project is rooted in the belief that integrated approaches to the discovery of factors affecting human longevity must be pursued. LC research includes 6 research projects and 3 cores, all focusing on, and leveraging, very complementary high-throughput assays, large cohorts and novel analytic methods. An emphasis is placed on systems biology and chemoinformatics analysis to help place the findings of each project into more coherent views of the molecular pathways and processes affecting longevity and their amenability to pharmacologic manipulation.
Principal Investigators: Steven R. Cummings, MD
Project Director: Dan Evans
Research Area: Aging/Longevity
Status: Ongoing
Website: https://www.longevityconsortium.org/
Longevity Genomics
Integrative Resource to Develop Translational Strategies to Promote Longevity
Translation of genetic associations into insights that can lead to pharmacological interventions designed to promote healthy aging requires an approach and infrastructure that integrates many sources of information and scientific expertise. We propose the creation of an infrastructure and an integrated data system to enable our team of scientists to develop therapeutic research strategies based on causal connections between molecular traits and healthy aging, and chemicals that target the molecular traits. Therapeutics that can promote healthy aging can have a great impact on the elderly, a rapidly growing subgroup of our population
Principal Investigator: Steven R. Cummings, MD
Project Director: Dan Evans, PhD
Research Area: Aging/Longevity, Genetics
Status: Completed
Website: http://www.longevitygenomics.org
Look AHEAD
Action for Health in Diabetes
This study is a randomized controlled clinical trial that is designed to characterize the impact on several health outcomes of an intervention program designed to produce weight loss. The primary study objective is to determine whether such a program is effective in reducing the number of serious cardiovascular disease events in a cohort of overweight adults with type 2 diabetes. The Coordinating Center serves as the bone density quality assurance group for the study. Hip, spine, and whole body scans are sent to us for quality and technical review and central databasing.
Principal Investigator: Michael C. Nevitt, PhD, MPH
Project Director: Ann V. Schwartz, PhD, MPH
Research Area: Cardiovascular, Diabetes
Status: Ongoing
MOST
Multi-center longitudinal, prospective observational cohort study of knee osteoporosis
This study looks at risk factors for the development and progression of knee osteoarthritis and knee pain. A cohort of more than 3,000 women and men, aged 50 and over are participating in follow-up visits to help investigators better understand how to prevent and treat knee osteoarthritis, one of the most common causes of disability in adults.
Principal Investigator: Michael C. Nevitt, PhD, MPH
Project Director: Jean Hietpas, MSW, OTR
Research Area: Osteoarthritis
Status: Completed
Website: https://most.ucsf.edu
MrOS
Osteoporotic Fractures in Men
This prospective cohort study is designed to examine the extent to which fracture risk is related to bone mass, bone geometry, lifestyle, anthropometric and neuromuscular measures, and fall propensity, as well as to determine how fractures affect quality of life in older men. A total of 5,995 from six US clinical centers were enrolled between March 2000 and April 2002. Participants have been followed since enrollment for incident fractures, falls, prostate cancers, and death. The MrOS study is funded by NIA and NIAMS, currently through June 2012.
Principal Investigators: Douglas C. Bauer, MD, Steven R. Cummings, MD
Project Director: Robin M. Fullman, MPH
Research Area: Bone, Osteoporosis
Status: Ongoing
Website: https://mrosonline.ucsf.edu/
MrOS R56
Long-term fracture risk in older men: the MrOS study
Fractures and resulting morbidity, mortality and costs are a large and growing burden among older men.The fracture rate increases exponentially after age 65, and the average age of hip fracture is >80 yrs. Fracture risk in later life is strongly influenced by declines in bone structure and strength. Yet, in older men there are very few studies with longitudinal data concerning these changes in bone structure. Thus, this study will focus on repeating measures of bone structure and strength using HR-pQCT technology in men participating in the MrOS study, all of whom are now aged 84 years and older. This grant is a multi-PI study (Mary L. Bouxsein, PHD, Peggy M. Cawthon, PhD, Eric S. Orwoll, MD ) funded by the NIH, under the “high priority, short term project” (R56) award mechanism. This project will serve as a foundation for future work including identification of predictors of change in bone strength and size at the peripheral skeleton.
Principal Investigator: Peggy M. Cawthon, PhD
Project Director: Robin Collins, MPH
Research Area: Bone
Status: Ongoing
MrOS Sleep
Outcomes of Sleep Disorders in Older Men
This study is an ancillary study to the MrOS study. From December 2003 through March 2005, 3,135 MrOS participants were enrolled. Comprehensive and objective assessments of sleep (including overnight in-home polysomnography[PSG], 5-day wrist actigraphy and self-reported measures of sleep quality), adjudication of incident cardiovascular (CVD) events, and other measures including neuromuscular function, bone mineral density, and cognitive function were added to the expansive dataset of the MrOS study. The MrOS Sleep Study is funded by NHLBI. Current funding is through April 2014.
Principal Investigator: Katie L. Stone, PhD
Project Director: Robin M. Fullman, MPH
Research Area: Aging/Longevity, Cardiovascular, Sleep
Status: Completed
Website: https://mrosonline.ucsf.edu/
OAI
Osteoarthritis Initiative
This study is a scientific evaluation of biomarkers for osteoarthritis as potential surrogate endpoints for disease onset and progression.
Principal Investigator: Michael C. Nevitt, PhD, MPH
Project Director: Susan M. Rubin, MPH
Research Area: Osteoarthritis
Status: Completed
Website: http://oai.ucsf.edu
PaTH/PaTH II
PTH and Alendronate in Combination for the Treatment of Osteoporosis
<Follow-up of PTH and Alendronate in Combination for the Treatment of Osteoporosis PaTH was a 2-year randomized controlled trial of 238 participants at 4 clinical sites to determine if 3 different combination treatments of PTH 1-84 with alendronate increased bone mineral density and bone turnover markers more than alendronate alone. PaTH II was a 1-year observational study designed for a 3rd year of follow-up in women originally randomized into PaTH to assess if MBD continues to increase or is maintained in those treated with PTH followed by a bisphophonate.
Principal Investigator: Dennis M. Black, PhD
Project Director: Trisha F. Hue, PhD, MPH
Research Area: Bone, Osteoporosis
Status: Completed
PICS
PTH and Ipandronate Combination Study
This is a randomized, placebo-controlled trial in which two combinations of PTH and oral ibandronate (Boniva®) are used to determine the effect on bone markers and bone mass. Forty-four post-menopausal women aged 55+ with low bone density as measured by densitometry were enrolled in this single-center pilot study. Participants will have 24 months of follow-up for clinical exams, imaging, and biomarker measurements. The study includes novel imaging methods including high resolution peripheral CT and MRI X-ray spectroscopy.
Principal Investigator: Dennis M. Black, PhD
Project Director: Jean Hietpas, MSW, OTR
Research Area: Bone, Osteoporosis
Status: Completed
Regulatory qualification for DXA bone mineral density as a surrogate endpoint for fracture risk in osteoporosis trials
The UCSF Bone Quality study have compiled data in over 150,000 patients (including serial DXA bone BMD measurements) and this effort presents a unique opportunity to develop change in BMD as a surrogate measure for fracture risk reduction. This could potentially enable future clinical trials with as few as several hundred patients in as little as 12 to 18 months to assess the relationship of the new agent to fracture risk. Using data from this unique compilation of patients, from up to 59 randomized trials of 17 different osteoporosis treatments, we will explore the relationship of DXA and biomarkers to fracture risk. The overarching goal of this project is to assess how DXA BMD, perhaps in combination with other imaging and biochemical markers, can be qualified as FDA-defined prognostic, predictive and efficacy-response biomarkers for fracture risk and submit a full qualification package to the FDA to qualify DXA-BMD as a surrogate marker for fracture risk.
Principal Investigator: Dennis M. Black, PhD
Project Director: Lucy Wu, MPH
Research Area: DXA-BMD, Biomarkers, Surrogate Measure
Status: Ongoing
ROSTERS
Randomized Order Safety Trial Evaluating Resident Schedules
Dr. Katie Stone is serving as the PI of the Data Coordinating Center (DCC) for the ROSTERS Trial (Randomized Order Safety Trial Evaluating Resident Schedules). ROSTERS is a multi-center randomized crossover trial in six pediatric ICUs staffed by PGY2 and PGY3 residents to compare the effectiveness and safety of a sleep and circadian science-based (SCS) intervention schedule with a traditional schedule that includes frequent shifts of 24 hours or longer. The primary outcome is resident-related preventable adverse events and near misses, and the secondary outcomes are ICU-wide preventable adverse events and near misses and resident neurobehavioral performance and predicted driving safety. The study aims to enroll 300 residents over the course of three years. The first wave of two sites began data collection on November 1, 2013.
Principal Investigator: Katie L. Stone, PhD
Project Director: Dana Kriesel, MPH
Research Area: Aging/Longevity, Cognitive function, Sleep
Status: Completed
Sleep Cog
Changes in Sleep and Cognition in Older Women
This study is designed to look at the relationship between poor sleep quality and cognitive function and mortality. The study will also explore potential biochemical pathways that may mediate the inter-relationships between sleep conditions, cognition, and mortality.
Principal Investigator: Katie L. Stone, PhD
Project Director: Dana Kriesel, MPH
Research Area: Aging/Longevity, Cognitive function, Sleep
Status: Completed
SOF
Studies of Osteoporotic Fractures
At the onset of this study 20 years ago, the main specific aims were to determine risk factors for hip and other osteoporotic fractures. Since then, the aims have expanded to include additional diseases and conditions common in older women, including breast cancer, osteoarthritis, stroke, cognition, vision, and sleep.
Principal Investigator: Steven R. Cummings, MD
Project Director: Dana Kriesel, MPH
Research Area: Bone, Osteoporosis
Status: Completed
Website: http://sof.ucsf.edu
SOMMA
The Study of Muscle Mobility and Aging
In the Study of Muscle Mobility and Aging (SOMMA), a prospective, longitudinal study of men and women age 70 to 90, our team of experts in clinical and laboratory sciences will use innovative and state-of-the-art technologies with rigorous quality control to test these hypotheses and discover new pathways for the loss of mobility with aging. We will measure quadriceps contractile volume by MRI and total muscle mass by d3 creatine dilution. We will use 31PMRS to assess the capacity of the quadriceps to generate ATP (ATPmax). In tissue form muscle biopsies quantify denervation and oxidative damage to contractile proteins. SOMMA will be the first to quantify autophagic flux to assess the role of autophagy in the loss of mobility with aging. We use respirometry on fresh tissue to quantify the contribution of mitochondria to ATPmax and mobility disability. These properties interact: for example, decreased autophagic flux promotes the accumulation of oxidative damage and denervation, and understanding these relationships will guide the analysis and interpretation of our results. Furthermore, we will use unbiased RNA-sequencing (RNA-seq) to profile the entire transcriptome to discover new associations between clusters of genes and individual variation in rates of loss of fitness (peak VO2), muscle mass, and risk of mobility disability.
SOMMA may identify and prioritize targets for new therapeutics and tailored exercise regimens. We also will create a unique archive of tissue, blood, with longitudinal data about important clinical outcomes that the scientific community can use to efficiently test new hypotheses about muscle and loss of mobility with aging.
Principal Investigator: Steven R. Cummings, MD
Project Director: Robin Collins, MPH
Research Area: Aging Muscle, mobility
Status: Ongoing
STRIVE
The STRIVE Study: Breast Cancer Screening Cohort for the Development of Assays for Early Cancer Detection
Detection of early stage cancer may be possible through analysis of circulating cell-free nucleic acids (cfNAs) shed into the blood by tumors. Using high-intensity sequencing (based on broad genomic coverage and deep sequencing) of cfNAs, combined with machine learning, to develop blood tests to detect cancer early. The purpose of this prospective, multi-center, observational cohort study is to train and validate an assay for the early detection of breast cancer. The study will collect blood samples from participants within 28 days of their screening mammogram. Additional blood samples will also be collected for a subset of participants. For participants who receive a cancer diagnosis during the study, tissue samples will be collected.
Principal Investigator: Steven R. Cummings, MD
Project Director: Dana Kriesel, MPH
Research Area: Breast Cancer
Status: Completed
Website: http://www.joinstrive.com/
TOLSURF
Trial of Late Surfactant in Premature Babies
This study is a randomized, multi-center, placebo-controlled trial of late surfactant treatment in infants at high risk of bronchopulmonary dysplasia (BPD). The primary aim of this nationwide trial, funded by NHBLI, is to assess the effect of late doses of surfactant on the occurrence and severity of BPD in ventilated, extremely low gestational age newborns (ELGAN) receiving inhaled nitric oxide (iNO). A cohort of 524 infants will be enrolled and followed for up to 24 months to help investigators better understand whether surfactant will decrease risk of chronic lung disease and improve pulmonary outcome in the ELGAN population. See also TOLSURF-Pilot.
Principal Investigator, Clinical Coordinating Center: Roberta Ballard, MD
Principal Investigator, Data Coordination Center: Dennis M. Black, PhD
Project Director: Jean Hietpas, MSW, OTR
Research Area: Neonatology
Status: Completed
TOPAZ
Prevention of Fractures in Patients with Parkinson's Disease
Patients with Parkinson’s disease have a high risk of falls and fractures but few receive treatment. TOPAZ is a randomized trial testing whether intravenous Zoledronic acid given at home reduces risks of falls and fractures without burdensome clinic visits. TOPAZ addresses all of these barriers:
1) We will test the anti-fracture efficacy of Zoledronic acid (ZA) a very potent bisphosphonate that inhibits bone loss and decreased fracture risk in women with osteoporosis and patients with hip fractures.
2) We will give ZA intravenously at home without clinic visits.
3) ZA inhibits bone loss for at least 2 years overcoming noncompliance with oral drugs. We will enroll 3,500 men and women PD age 65 years or older from large health systems, patient communities, and referrals from neurologists in the Parkinson’s Study Group.
A successful result may revolutionize the care of patients with PD. It may lead to guidelines promoting home-based ZA treatment of older PD patients. ZA, rather than oral drugs, would become the 1st line treatment for patients with PD. Thus, a positive result may lead to treatment of many more PD patients and a substantial reduction in the occurrence of disabling fractures in patients with PD.
For patients:
For more information on TOPAZ and to enroll in the study, call 1-800-4PD-INFO (1-800-473-4636). You may be referred to UCSF to arrange a telemedicine neurology assessment at home to confirm that the study is right for you.
For Parkinson’s disease specialists:
Call 1-800-4PD-INFO (1-800-473-4636) for more information on enrolling patients directly into the trial. Patients who have previously suffered a hip fracture or have kidney failure may be eligible to participate.
Principal Investigator: Steven R. Cummings, MD
Project Director: Dana Kriesel, MPH
Research Area: Bone, Osteoporosis, Aging, Parkinson’s disease
Status: Ongoing
Website: https://www.topazstudy.org/
Welcome to TOPAZ (video): https://www.youtube.com/watch?v=cIqyVfmsYaE
VEST-PREDICTS
Vest prevention of Early Sudden death Trial (VEST); PREDiction of ICD Therapies Study (PREVENTS)
This study is a multi-center randomized controlled trial and observational follow-up study designed with the goal of improving clinical care for persons at risk of sudden death from heart arrhythmias. Participants include men and women aged 18 years and older with some heart dysfunction after a recent heart attack. The goal of VEST is to determine whether use of a wearable defibrillator vest reduces death in the first 2 months following the heart attack. In PREDICTS, extensive risk stratification testing will be performed and biological samples collected from each study participant with the goal of predicting which persons truly require implantation of a cardioverter-defibrillator device (ICD).
Principal Investigators: Stephen B. Hulley, MD, MPH, Mark J. Pletcher, MD, MPH
Project Director: Trisha F. Hue, PhD, MPH
Research Area: Cardiovascular
Status: Ongoing
Zolpidem and Cognitive Behavioral Therapy for Insomnia in Older Adults
Planning funding is provided for the development of a large multi-center randomized trial designed to test the comparative effectiveness of zolpidem versus cognitive behavioral therapy for insomnia in older adults. The trial will be powered to test key outcomes in older adults such as falls, cognitive and physical function, and cardiovascular risk factors.
Principal Investigator: Katie L. Stone, PhD
Project Director: Dana Kriesel, MPH
Research Area: Aging/Longevity, Sleep, Cognitive function
Status: Completed