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    Home
          Grants & Funding: The NIAMS Extramural Program
          Clinical Trials in the Spotlight
          Clinical Trials in the Spotlight - Completed Studies with Published Results








Clinical Trials in the Spotlight - Completed Studies with Published Results FacebookEmailPrintFacebookEmail     
    Completed Studies with Published Results

This page features extramurally funded clinical trials supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) that are complete and have published results. Click on a disease/condition below to learn more about a range of clinical trials that NIAMS supported and how they contributed to generating new knowledge about prevention and treatment of arthritis, musculoskeletal and skin diseases. Please note that this page does not include the full portfolio of completed trials with results supported by the NIAMS. Studies with results that completed as of May 2019 are added to this page.

**Please check other clinical trials supported by the NIAMS that are actively recruiting or have completed recruitment following the links below.**View Actively Recruiting StudiesView Active Studies with Completed Recruitment
For questions, please contact the NIAMS Clinical Trials team at: NIAMSclinicaltrials@mail.nih.gov



Disease / Condition

Anterior Cruciate Ligament (ACL) Injury
	Atrophy
	Bone Remodeling
	Chronic Refractory Gout
	Hip Fractures
	Herpes Zoster (HZ)
	Pelvic Fractures
	Post-Menopausal Osteoporosis
	Rheumatoid Arthritis
	Systemic Sclerosis (SSc)
	Traumatic Knee InjuryAnterior Cruciate Ligament (ACL) Injury

**Reduction of Risk Factors for ACL Re-Injuries Using An Innovative Biofeedback Approach**

Nearly 1 in 60 adolescent athletes will suffer ACL injuries. Approximately 90% of these injured athletes will undergo an ACL reconstruction at an estimated annual cost of $3 billion. While reconstruction and subsequent rehabilitation allow these athletes to return to sports, they have a 15-fold increased risk of secondary ACL injuries, a tear of the ACL graft or the contralateral ACL. As a result, development of an intervention to reduce the incidence of secondary ACL tears would meet a critical need.

The long-term objective of this study is to decrease the number of secondary ACL tears by decreasing side-to-side movement and loading asymmetry. Specifically, this study proposes to evaluate a novel biofeedback training program that focuses on altering loading and movement patterns to improve symmetry and overall lower extremity mechanics in a group of 40 (20 control, 20 intervention) adolescent ACL reconstructed patients.

View more about this trial in ClinicalTrials.gov

Atrophy

**Translational Control of Anabolic Resistance in Aging Muscle**

The loss of skeletal muscle mass, strength, and physical function with age (sarcopenia) has numerous physiological and metabolic consequences that may lead to undesirable outcomes in older adults. Skeletal muscle plays a direct role in force production and its loss can lead to reduced mobility, loss of balance, increased incidence of falls and ultimately disability and loss of independence. In addition, muscle plays an underappreciated role in metabolism and sarcopenia has been associated with insulin resistance and metabolic syndrome. Consequently, identifying interventions that maintain muscle mass and function is a high priority therapeutic goal to improve quality of life and reduce medical costs associated with older adult populations. Dietary intake of the branch-chained amino acid leucine increases the rate of protein synthesis in skeletal muscle through mechanistic target of rapamycin complex 1 (mTORC1)-dependent as well as independent signaling pathways. However, physical inactivity reduces the ability to stimulate muscle protein synthesis in response to amino acids, termed anabolic resistance. Since older adults are at a greater risk of being inactive due to injury, illness or sedentary behavior, it is thought that anabolic resistance to amino acids may contribute to the development of sarcopenia.

View more about this trial in ClinicalTrials.gov

Bone Remodeling

**Sleep Disturbance: A Novel Risk Factor for Impaired Bone Remodeling**

Sleep disturbance negatively impacts many biological systems and may be detrimental to skeletal health. Bone remodeling, which is important for bone mass and strength, increases overnight, a time when millions experience disrupted sleep. Epidemiological data and animal studies suggest a link between sleep disturbance and bone but the direction and the mechanisms by which sleep affects bone are not fully understood. The overall objective of this project is to establish and quantify the skeletal effects of disrupted sleep and to investigate the mechanisms by which bone remodeling and sleep are linked. The central hypothesis is that sleep disturbance (e.g., sleep loss, circadian shifts) negatively impacts bone health by altering the balance between bone resorption and bone formation and is particularly detrimental during skeletally vulnerable periods such as during and after the menopausal transition.

View more about this trial in ClinicalTrials.gov

Chronic Refractory Gout

**REduCing Immunogenicity to PegloticasE (RECIPE) Study**

Pegloticase is highly efficacious therapy for chronic refractory gout patients. It decreases serum urate (sUA) levels to often undetectable levels and reduces tophi burden. However, its long- term real-world effectiveness is severely limited due to its immunogenicity caused by anti-pegloticase antibody formation. This study investigates the preliminary efficacy and safety of using immune modulating therapy with mycophenolate mofetil (MMF) to prevent immunogenicity conferred by pegloticase.  Chronic Refractory Gout

The primary aims of this trial are to 1) determine if a 12-week course of immune modulating therapy with daily MMF can safely and significantly attenuate immunogenicity to pegloticase as determined by the proportion of participants achieving and maintaining an sUA less than or equal to 6 mg/dL through 12 weeks, compared to concurrent controls, and 2) to assess the incidence and types of adverse events and infusion reaction.

View more about this trial in ClinicalTrials.gov

Hip Fractures

**Hip Fracture Evaluation Alternatives Total Hip vs. Hemi-arthroplasty (HEALTH)**

Hip fractures occur in 280,000 Americans, over 5,000 per week. During the next 40 years, the number of hip fractures is likely to exceed 500,000 annually, and the estimated annual health care costs will reach a staggering $9.8 billion. Hip fracture patients are at risk of a 30% mortality rate and impairment of independence and quality of life. Hip fractures are commonly treated with a hip replacement, or arthroplasty. Two common types of arthroplasty exist, total hip arthroplasty (THA) and hemi-arthroplasty (HA). Advocates of hemi-arthroplasty (HA) focus upon reduced dislocation rates, lower rates of deep vein thrombosis, shorter operating times, less blood loss, and a technically less demanding procedure. Surgeons supporting THA perceive benefits in improving patient function and improving quality of life. Methodological limitations of previous studies, as well as their small sample sizes and resulting wide confidence intervals, have left the optimal operative approach unresolved.

View study results at ClinicalTrials.gov

Herpes Zoster (HZ)

**Safety and Effectiveness of Live Zoster Vaccine in Anti-TNF Users (VERVE Trial)**

Herpes zoster (HZ), also known as "shingles", is caused by reactivation and multiplication of the ubiquitous varicella zoster virus (VZV) that remains latent in everyone's sensory neurons following varicella, or "chickenpox". Among individuals who live to age 85, the lifetime risk for HZ is 50%, and more than one in five individuals affected by zoster develop post-herpetic neuralgia, resulting in chronic pain. Other serious complications include encephalitis, permanent vision loss, or more rarely, dissemination and death. Fortunately, a live attenuated vaccine is available and can reduce HZ risk by up to 70%. For patients with rheumatoid arthritis (RA), this vaccine has great potential to provide improved quality of life by reducing the incidence and complications associated with zoster. Due to the underlying disease and/or treatments (e.g. steroids) for rheumatoid arthritis (RA), the risk of herpes zoster in RA patients is approximately double in the general population. This increased risk should make prevention of zoster and vaccination exceedingly important for RA patients.

In light of 1) a substantial elevated HZ risk among RA patients; 2) national data showing most RA patients are not vaccinated for HZ; and 3) the high effectiveness of this vaccine in the general population, the investigators propose to conduct the Varicella zostER VaccinE (VERVE) trial, a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and long-term effectiveness of the live herpes zoster vaccine.

View more about this trial in ClinicalTrials.gov

Pelvic Fractures

**PTH(1-34) and Pelvic Fracture Healing - a Randomized Controlled Trial**

This randomized, double-blind, placebo-controlled 3-month study tests the efficacy of teriparatide (TPTD) to accelerate fracture healing in women and men ≥ 65 years of age with acute fractures of the pelvis.  The investigator hypothesizes that TPTD for 3 months as an adjunctive therapy in addition to standard of care will accelerate radiographic evidence of fracture healing and functional recovery and that differences between TPTD and placebo groups documented at 3 months of treatment will persist when evaluated up to 12 months.

View more about this trial in ClinicalTrials.gov

Post-Menopausal Osteoporosis

**Consolidating Skeletal Benefits after Short-Term Combination Ostoporosis Terapy: The DATA-EX Study**

Osteoporosis is a large and Growing public health concern that affects over 20 million American and leads to 1.5 million fractures every year. While various drugs are approved to treat osteoporosis, no agent is fully able to restore skeletal health in most patients with severe disease. This proposal aims to extend a proof-of-principle clinical trial that evaluates short-term therapy with a novel combination of osteoporosis medications followed by a single dose of a longer-acting agent. This treatment regimen has the potential to significantly improve the management of patients with established osteoporosis.

View more about this trial in ClinicalTrials.gov

Rheumatoid Arthritis

**Does Sildenafil Improve Endothelial Dysfunction in Rheumatoid Arthritis?**

Rheumatoid arthritis (RA) is associated with a 2-fold increased risk of cardiovascular disease (CVD), which is not explained by traditional cardiovascular (CV) risk factors alone. This risk is likely mediated in part through systemic inflammation. Indeed, RA itself is deemed to impart a CV risk equivalent to diabetes mellitus (DM). However, unlike in DM, optimal CV management strategies in RA are lacking. Despite improved anti-inflammatory therapies for RA, the mortality gap in RA compared to the general population is still widening, in part due to suboptimal primary and secondary CV preventive care in RA. To date, there have been no published controlled intervention trials for primary CV prevention in RA, despite this clearly urgent unmet need.

One of the early stages of atherogenesis is endothelial dysfunction, and drugs that target improvement in this are promising novel strategies for CVD prevention. The fundamental feature of endothelial dysfunction is impaired nitric oxide (NO) bioavailability. Sildenafil improves endothelial function by increasing NO signaling by inhibition of phosphodiesterase-5 (PDE5). PDE5 inhibitors improve endothelial function in pulmonary hypertension and DM and were safe and well tolerated in patients with erectile dysfunction and other CV comorbidities. Furthermore, PDE inhibitors have immunomodulatory properties that may be utilized to treat autoimmune conditions like RA.

This study hypothesizes that sildenafil is a uniquely suited agent targeting endothelial dysfunction as a novel adjunctive CV prevention strategy and immunomodulatory agent in RA.  Specifically, the study team aims to determine if sildenafil use in RA improves endothelial dysfunction and atherosclerosis biomarkers.

View more about this trial in ClinicalTrials.gov

Systemic Sclerosis (SSc)

**The Effect of Atorvastatin on Microvascular Endothelial Function and Raynaud in Early Diffuse Systemic Sclerosis**

Systemic sclerosis (SSc) is a multisystem autoimmune illness characterized by vasculopathy, immune system activation and fibrosis of the skin and internal organs. SSc affects approximately 240 people per million in the U.S. but is a disease for which there is no FDA approved medication. Current hypothesis of pathogenesis suggests that a vascular injury with endothelial dysfunction may be an inciting event contributing to immunologic activation and fibrosis in the pathogenesis of the disease. More than 90% of individuals with SSc have vascular complications including Raynaud phenomenon, digital ulcers or gangrene and pulmonary hypertension; with microvascular abnormalities felt to contribute to Raynaud and digital ulcerations.

Statin medications are well-recognized to have pleiotropic effects which may modify all three aspects of SSc pathogenesis. Early diagnosis and treatment of microvascular endothelial dysfunction and Raynaud phenomenon may have the greatest effect in early disease. Thus, this study hypothesizes that treatment with atorvastatin in a well-defined cohort of early diffuse systemic sclerosis will produce beneficial results.

View more about this trial in ClinicalTrials.gov

**A Double-blinded, Placebo-controlled Pilot Study of Dimethyl Fumarate (DMF) in Pulmonary Arterial Hypertension (PAH) Associated With Systemic Sclerosis (SSc-PAH): The Effect of DMF on Clinical Disease and Biomarkers of Oxidative Stress**

Systemic sclerosis (SSc) is a complex, multifactorial autoimmune disease characterized by fibrosis and vasculopathy in skin and various internal organs such as the lungs, kidneys and heart disease with no specific treatment. Pulmonary arterial hypertension (PAH) is a common complication of SSc, and compared to other subgroups of PAH patients, responds poorly to currently approved vasodilators. Oxidative damage is a well-defined component of lung disease in SSc as well as in other organs and pathology studies have shown evidence of oxidative damage in SSc lungs. Dimethyl fumarate (DMF), recently been approved as a treatment for multiple sclerosis, triggers the general response to oxidative damage through Nrf2, resulting in the induction of multiple enzymes designed to counteract the oxidative process. Preclinical studies by the study team as well as other groups have shown that DMF inhibits PAH in murine models. In addition, multiple markers of oxidative stress are elevated in patients with SSc and SSc-PAH, suggesting that this is an important pathway mediating vascular damage in SSc-PAH. On the basis of these studies, the study team proposes a double-blinded, placebo-controlled study of DMF added to stable background, standard of care PAH therapy in SSc‐PAH patients, comparing the change in 6-minute walk distance (6MWD) at 24 weeks to baseline in DMF compared to placebo-treated patients.

View more about this trial in ClinicalTrials.gov

Traumatic Knee Injury

**Prevention of Skeletal Muscle Adaptations to Traumatic Knee Injury and Surgery**

Traumatic knee injury is common and highly debilitating. Surgical reconstruction/repair improves knee biomechanics and function, but neuromuscular dysfunction persists for years despite rehabilitation, hindering resumption of normal activities, increasing the risk of further injury and, in a majority of patients, hastening the development of knee osteoarthritis (OA). The period from the injury through the early, post-surgical period is critical for the development of functional deficits, as the trauma of the injury and surgery combine with muscle disuse to reduce skeletal muscle size and intrinsic function.

This study aims to evaluate the utility of neuromuscular electrical stimulation (NMES), initiated following injury and maintained through the early post-surgical period, to prevent muscle atrophy and intrinsic contractile dysfunction.

View more about this trial in ClinicalTrials.gov


Last Updated: August 2022


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