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Clinical Trials Need a Broader Approach to Improve Osteoarthritis Outcomes
Risk factors, racial disparities and sex differences should all be considered
Feb 11, 2021
Aug 28, 2024
Women's Health PolicyFounder and President of Institute for Women’s Health Strategies
CEO, Alliance of Sleep Apnea Partners
Monica Mallampalli, Ph.D. is a trained biomedical scientist and brings a unique perspective to women’s health — from science and research to policy and advocacy. Dr. Mallampalli considers herself a women’s health advocate. Using the lens of sex and gender differences, she has brought attention to knowledge gaps in science and policy in several areas of women’s health, including chronic pain, sleep health, cardiovascular health, musculoskeletal health, autoimmune disease, mental health, breast cancer, Alzheimer’s disease, urological health and clinical trials. Dr. Mallampalli has authored many research papers and opinion articles, and has been interviewed by the media on multiple occasions.
Previously, Dr. Mallampalli served as the senior scientific advisor at HealthyWomen, where she brought national attention to women and chronic pain, and she now serves as the chair of HealthyWomen’s chronic pain advisory council, which she established in 2020. Prior to HealthyWomen, Dr. Mallampalli served as the vice president of scientific affairs at the Society for Women’s Health Research (SWHR). Dr. Mallampalli has also worked at the National Institutes of Health as a Health policy analyst and as a research fellow. She obtained her post-doctoral fellowship at the Johns Hopkins University School of Medicine’s Department of Cell biology.
She earned her Ph.D. at the University of Utah in Human Genetics and received a Master of Sciences with a concentration in biochemistry from Osmania University in India. Dr. Mallampalli is the founder and CEO of the Institute for Women’s Health Strategies focused on applying data-driven strategies and solutions to advance and improve the science of women’s health. Currently, she serves as the executive Director at the Alliance of Sleep Apnea Partners (ASAP).
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Risk factors, racial disparities and sex differences should all be considered
As the most common form of arthritis, osteoarthritis affects more than 32 million adults. The disease is characterized by a gradual breakdown of the cushions between bones, which can lead to joint pain and stiffness in the hands, knees, hips, lower back and neck.
Some osteoarthritis improves with physical therapy, but if it doesn't, the majority of treatment options available at this time are invasive. These can include steroid or lubrication injections, realignment of bones and, in more severe cases, joint replacement surgery. For the 27.5 million Americans without health insurance, most of these treatments are unaffordable. At an average price of slightly more than $31,000, the cost may be more than an annual salary.
Treatment for this common condition should not be out of reach for most Americans, which is why clinical trials should continue to focus on developing noninvasive treatment options, such as medications that are affordable with or without insurance.
As one of the leading causes of disability, osteoarthritis can be affected by a number of factors. Injury and malalignment of joints can contribute to an onset, but other factors such as sex, age, race, ethnicity, genetics and diet also play a role. For example, women are at higher risk for developing the disease in their hands and knees. For knee osteoarthritis in particular, the condition can have a significant impact on quality of life.
Having obesity is one of the biggest risk factors for osteoarthritis, and for knee osteoarthritis in particular, having obesity is the main risk factor. Extra weight puts stress on the knees and can cause inflammation that can further escalate or even cause osteoarthritis.
Osteoarthritis can also have a major impact on the heart, which is especially important to consider this February as we celebrate and raise awareness for National Heart Month. Individuals with osteoarthritis were found to be three times as likely to have heart failure and ischemic heart disease.
Another condition that has been found to have a correlation to osteoarthritis is type 2 diabetes. For diabetic individuals, insulin resistance has the potential to damage cartilage, bone and tissue. This can further reduce mobility and contribute to the development or cycle of osteoarthritis.
Minority groups are affected more than others by disparities in access, treatment and outcomes for osteoarthritis. Black Americans were found to have increased risk of worse outcomes for hip and knee osteoarthritis. Preliminary research is tying limited access to rehabilitation care, fewer referrals, lower utilization rate and perceived bias to the higher risk level. Additionally, self-reliance (or not seeking out medical care) is thought to be another contributing factor.
Studies have found that Black individuals were less likely to receive care that was up to standards with clinical guidelines. In fact, a review of knee arthroplasty studies discovered that out of seven studies, five showed that Black Americans had worse pain and function than white Americans. They were also found to experience more complications after total hip arthroplasty.
Currently, osteoarthritis severity and disability levels remain higher among Black individuals. While the prevalence of arthritis diagnosed by an HCP is nearly the same for Black and white Americans (hovering around 22%), Black Americans report nearly 10% higher rates of activity limitations. The numbers climb even further for multirace, non-Hispanic individuals and American Indians or Alaska natives, with about 50% of people reporting limitations.
Additionally, Black and Hispanic Americans have fewer office-based therapy visits each year. Since physical therapy is often an essential tool in managing osteoarthritis, barriers in access to care — whether from lack of health insurance, lack of access to transportation, costs or other socioeconomic factors — must be addressed as we continue to study the disease.
As we continue to think about how we can address disparities in osteoarthritis, reduce risk levels, and raise awareness for causes and impacts of the disease, it's essential that we look at several areas. First, more clinical trials that aim to identify noninvasive treatment options, such as medication, will be a huge step in making osteoarthritis management affordable and accessible.
Next, we must look at racial disparities and resolve issues like low rates of referrals and standards of care. Then, it's important to further research sex differences to understand why women present higher risk for developing osteoarthritis in the knees, a particularly debilitating form of the disease. Finally, we must raise awareness of contributing factors to the disease, such as obesity and diabetes. We must also educate others about the elevated risks osteoarthritis can cause to heart health, among other areas.
Through research, education and awareness (including in clinical trials), we can help the millions of Americans living with osteoarthritis to regain function, feel safe seeking out medical care, have affordable access to treatment and gain a better understanding of how the disease works. We can also reduce the risks for future generations to come.