Musculoskeletal Diseases

All Conditions

Diseases and Abnormalities at or Before Birth

Respiratory Tract (Lung and Bronchial) Diseases

Scoliosis

Congenital Abnormalities

Respiration Disorders

Respiratory Tract Diseases

Spinal Curvatures

Spinal Diseases

Bone Diseases

patients diagnosed with scoliosis and other spinal deformities

Michele M Doody

Background:

Scoliosis is a curving of the spine. It usually happens in girls when they are children and teens. Doctors often use x-rays to diagnose it. The x-rays give low radiation. This may increase the risk that those young women get cancer later in life. Researchers want to learn more about this risk. They will look data that has already been collected.

Objectives:

To study cancer risks of repeated low radiation from x-rays for scoliosis. Also, to study death risks related to certain scoliosis patient characteristics. These include causes, kinds of curvature, and kinds of treatment.

Eligibility:

Medical records of women from past scoliosis studies.

Design:

This U.S. Scoliosis Cohort includes more than 5,000 women who were diagnosed between 1912 and 1965.

Data were collected on these women in the 1980s and 1990s. These came from medical records, radiology log books, and x-ray films. Researchers found out where participants were, including if they were dead. Some women were given a follow-up questionnaire.

Researchers want to find out where participants are today. They want to identify new deaths of participants. They want to find out their causes of death. This data will be added to other databases.

U.S. Scoliosis Cohort includes 5,573 female spinal deformity (93% scoliosis) patients diagnosed in any of 14 medical centers in the U.S. during 1912-1965. The primary objective of this study is to evaluate site-specific cancer risks associated with repeated low-dose radiation exposures from diagnostic x-rays. A secondary objective is to evaluate late mortality risks associated with patient characteristics, such as etiology, degree and type of curvature, and type of treatment. The current proposal is to extend mortality follow-up by 10 years. All patients not known to be deceased will be submitted to the National Death Index Plus to identify new deaths and obtain causes of death.

A feasibility study was conducted in four medical centers in the Minneapolis-St. Paul, Minnesota area during 1983-1987. The primary goals of the feasibility study were to ascertain if an adequate number of patients meeting the study criteria could be identified and located, medical and radiography records were available and substantially complete, organspecific radiation doses could be estimated from the available data and were large enough to warrant further study, and a reasonable percentage of patients would complete a follow-up questionnaire. The feasibility study was successful in meeting all goals. Enrolled for study were 1,030 female patients with spinal deformities diagnosed during 1922-1965. Medical records were abstracted, individual x-ray films were reviewed, patients were located, and follow-up questionnaire was administered to identify incident cancers. Eleven breast cancers were reported. Scoliosis patients had an 80% higher breast cancer risk compared to women in the general population and, based on internal cohort analyses, breast cancer risk increased with increasing number of x-rays and with estimated radiation dose to the breast.

An expanded study was conducted during 1988-1993. The main goals of the expanded study were to enlist the collaboration of suitable additional medical centers where large numbers of spinal deformity patients were treated before 1966, abstract data from medical and radiology records, trace patients for vital status and current location, obtain information on incident cancers and cancer risk factors by questionnaire, medically validate reported cancers, and determine causes of death for decedents. Another 4,543 patients diagnosed during 1912-1965 were enrolled from ten hospitals, bringing the total study population to 5,573 patients. Compared to women in the general population, spinal deformity patients had statistically significantly higher risks of dying from breast cancer, and for both incidence and mortality, breast cancer risk increased with increasing diagnostic radiation exposure to the breast. Patients also have elevated risks for mortality from all causes, circulatory, respiratory, nervous system, musculoskeletal, digestive, and infectious \& parasitic diseases, primarily related to degree of spinal curvature. Additional mortality follow-up will enable more definitive assessments of cancer and other disease risks with radiation and other factors in these patients.

Follow-Up Study of People Treated for Scoliosis

Breast and Other Cancers Following X-Rays for Scoliosis

Social & Scientific Systems Inc.

National Cancer Institute (NCI)

Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

Behaviors and Mental Disorders

Nervous System Diseases

Infections

Symptoms and General Pathology

Wounds and Injuries

Digestive System Diseases

Diabetes Mellitus

Diabetes Mellitus, Type 2

Depressive Disorder

Dementia

Communicable Diseases

Tuberculosis

Depression

Liver Cirrhosis

Alcohol Drinking

Fibrosis

Mycobacterium Infections

Bacterial Infections

Gram-Positive Bacterial Infections

Mycoses

Bacterial Infections and Mycoses

Liver Diseases

Gastrointestinal Diseases

Anti-Infective Agents

Central Nervous System Depressants

All Drugs and Chemicals

Ethanol

Advice about alcohol intake following a Mediterranean Alcohol Drinking Pattern: Moderation (7 or less drinks/wk in women and 14 or less drinks/wk in men), avoidance of binge drinking, consumption of alcohol with meals and preference for red wine.

Remotely Intensive intervention by specialized coaches (psychologists, dietitians, and other health professionals) to promote a behavior change on alcohol consumption. Repeated quarterly small group sessions and periodical personal interviews and educational videos, during up to 4 years with 1 contact every 3 months.

Goals of intervention:

1. moderate consumption (7 or less drinks/wk for women, 14 or less drinks/wk for men) of red wine (a drink=150 ml).
2. always during meals
3. spread out throughout the whole week, and
4. avoidance of binge-drinking episodes. No participant will be invited to start or increase his/her alcohol intake.

Moderate Alcohol Drinking Pattern

Remotely Intensive intervention by specialized coaches (psychologists, dietitians, and other health professionals) to promote a behavior change on alcohol consumption. Repeated quarterly small group sessions and periodical personal interviews and educational videos, during up to 4 years with 1 contact every 3 months.

Goals of intervention:

Abstention. Message of 0 alcohol.

Abstention

Miguel A Martinez-Gonzalez, MD, MPH, PhD

Maira Bes-Rastrollo, PharmD, PhD

Estíbaliz Goñi, Nutritionist

Rafael Perez-Araluce, PharmD

The goal of this clinical trial is to test two advices on alcohol drinking in more than 10.000 Spanish adult drinkers (men of 50 or more years and women of 55 or more years).

The main question it aims to answer is to test the non-inferiority advice of a moderate alcohol drinking pattern on all-cause mortality and other chronic disease like cardiovascular disease, cancer or type 2 diabetes.

Participants will receive during 4 years an advice to drink alcohol following a Mediterranean Alcohol Drinking Pattern (MADP): consuming alcohol in moderation, avoidance of binge drinking and preference for red wine.

Researchers will compare those who will receive a MADP advice with those who will receive an advice on abstention to see if the advice on MADP is not inferior than the abstention advice to prevent all-cause mortality and other chronic diseases.

Policymakers and clinicians are currently perplexed on how to reduce alcohol harms in drinkers, because of contradictory guidelines: abstention is proposed as the healthiest option by many health advocates, stating that "there is no safe level of alcohol intake"; but most nonrandomized studies found lower all-cause mortality and other beneficial outcomes in moderate drinkers than in abstainers among subjects \&amp;gt;50 years. However, potential biases may compromise these latter studies, particularly when effects are null or moderate. A large pragmatic randomized controlled trial (RCT) of realistic advice aimed to change behaviour addressing clinical endpoints is long overdue. It will provide first-level evidence to confront the harms of one of the most widely used substances by humankind.

The European Research Council has funded, through an Advanced Research Grant (2023-2028) to the University of Navarra (Spain), as Host Institution, a 4-year non-inferiority RCT with more than 10,000 drinkers (men 50-70 years or women 55-75 years consuming 3 or more but 40 or less drinks/wk). The name of the trial is UNATI (University of Navarra Alumni Trialist Initiative).

At least ten thousand drinkers will be randomized in a 1:1 ratio to repeatedly (4 contacts/year) receive during 4 years two different advices:

1. abstention;
2. moderation (7 or less drinks/wk in women and 14 or less drinks/wk in men), avoidance of binge drinking, with preference for red wine consumed always with meals, and consumption spread out throughout the week, following the traditional Mediterranean Alcohol Drinking Pattern (MADP). Moderate consumption is hypothesized to be non-inferior. No initiation or increment in alcohol intake will be promoted.

The primary endpoint will be a global index of all-cause mortality, cardiovascular events, any invasive cancer, liver cirrhosis, type 2 diabetes, depression, dementia, injury requiring hospital admission or tuberculosis or other infections requiring hospitalization. As a secondary analysis, the most severe outcomes (mortality, invasive cancer, stroke, myocardial infarction, liver cirrhosis) will be considered independently with sufficient priority over less severe outcomes, using ad hoc methods.

The UNATI trial will provide for the first time an evidence-based answer to a question of the utmost interest in clinical medicine, given the high prevalence of moderate alcohol intake, and the current situation of equipoise with opposing views in the scientific community on the most sensible advice for moderate drinkers. The starting date for the project is December 1, 2023. The randomization of participants will start on June 2024.

Advice of Moderate Drinking Pattern Versus Advice on Abstention on Major Disease and Mortality

A Non-inferiority Randomized Trial Testing an Advice of Moderate Drinking Pattern Versus Advice on Abstention on Major Disease and Mortality

The generated dataset (completely anonymized) will be made available to every proficient researcher who may present a relevant research proposal to the Steering Committee for further exploitation of the data upon all the usual legal precautions for the protection of individual data will be respected.

The trial may not be long enough to observe effects on cancer endpoints. Therefore, a comparison between groups of cancer incidence endpoints after 10-year follow-up, assessed through the information on clinical records, will be included as an ancillary analysis.

Global index of all-cause mortality, cardiovascular events, any invasive cancer, liver cirrhosis, type 2 diabetes, depression, dementia, injury requiring hospital admission, tuberculosis or other infections requiring hospitalization evaluated from the information on clinical records.

The most severe outcomes (mortality, invasive cancer, stroke, myocardial infarction, liver cirrhosis) will be considered independently with sufficient priority over less sever outcomes, using ad hoc methods, using information on clinical records.

Clinica Universidad de Navarra, Universidad de Navarra

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Follow-Up Study of People Treated for Scoliosis	NCT02546479	Breast and Othe... All Cause Morta... Circulatory Dis... Respiratory Dis...		50 Years - 95 Years	National Institutes of Health Clinical Center (CC)
Advice of Moderate Drinking Pattern Versus Advice on Abstention on Major Disease and Mortality	NCT06338215	All Cause Morta... Cardiovascular ... Invasive Cancer Liver Cirrhosis Type 2 Diabetes Depression Dementia Injury Traumati... Tuberculosis Infections	Moderate Alcoho... Abstention	50 Years - 75 Years	Clinica Universidad de Navarra, Universidad de Navarra
Advice of Moderate Drinking Pattern Versus Advice on Abstention on Major Disease and Mortality	NCT06338215	All Cause Morta... Cardiovascular ... Invasive Cancer Liver Cirrhosis Type 2 Diabetes Depression Dementia Injury Traumati... Tuberculosis Infections	Moderate Alcoho... Abstention	50 Years - 75 Years	Clinica Universidad de Navarra, Universidad de Navarra

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