152 Clinical Trials for Various Conditions
Gaucher disease is a most common genetic metabolic disease characterized by low platelet number, liver and spleen enlargement and various forms of bone diseases including low bone mineral density leading to brittle bones. Various treatment options are now available for this disease. The purpose of this research study is to determine the prevalence of Gaucher disease in patients with low bone mineral density as observed by DEXA scan, which is a form of X-Ray of the bone.
The purpose of this study is to determine if there is correlation between Vitamin D deficiency and spinal disease/spinal fusion surgery.
The investigators hypothesis is that secondary causes of bone loss are prevalent in patients with breast and prostate cancer, and those patients with secondary causes of bone loss are at higher risk for treatment related bone loss. The goals of this pilot study are to estimate the prevalence of secondary causes of osteoporosis in a cohort of patients with nonmetastatic breast and prostate cancer with osteopenia and osteoporosis.
The purpose of this study is to determine whether consuming calcium carbonate that has been micronized is more effective than the traditional form of calcium carbonate in maintaining or increasing bone mineral density in people who are currently taking bisphosphonates or other bone-health medications.
This two-year open-label pilot clinical trial will evaluate the efficacy and safety of romosozumab to treat bone loss in females with chronic spinal cord injury (SCI) and osteoporosis (OP). Participants will receive monthly injections of romosozumab during the first 12 months of the study. During the second year, participants will take oral alendronate tablets on a weekly basis.
This study is an ancillary study to the Utilizing Protein During Weight Loss to Impact Physical Function (UPLIFT) trial (NCT03074643) to evaluate the effects of diet composition (i.e., amount of protein and carbohydrate) during a 6-month weight loss intervention and 12-months of follow-up on bone phenotypes in obese older adults. Participants will receive either a protein or carbohydrate supplement along with a behavioral weight loss intervention.
Bone disease and adrenal suppression are two of the many side effects of steroid use in pediatrics. Evidence has shown that adrenocorticotropic hormone (ACTH) protects against the adverse bone effects of steroids in animals and in vitro models, but this has not yet been evaluated in humans. The proposed mechanism in these studies is that ACTH stimulates osteoblasts in bone to release Vascular Endothelial Growth Factor (VEGF), which increases the vascularity in high risk areas of bone. This can potentially be protective against osteonecrosis and osteopenia, which can lead to bone fractures if not prevented. The VEGF release can also be used to demonstrate that an administration of exogenous ACTH occurred. This could be important in diagnosing adrenal insufficiency (AI). One of the tests to assess central AI is the low-dose ACTH stimulation test (LDAST). This test has a high rate of false positive results due to technical limitations. However, if an ACTH-stimulated VEGF level can be measured during the test as a marker of the test being done properly, it will allow for proper interpretation of the results (and identification of a false positive), which will reduce the number of patients being incorrectly diagnosed with central AI. This study will recruit ten healthy children and adolescents, ages 9-18, to assess the effects of ACTH on VEGF levels. The investigators will measure the response of VEGF and cortisol to an administration of a low dose and high dose of cosyntropin (the synthetic ACTH analog used in this test). The hypothesis of this study is that VEGF and cortisol will both increase after administration of cosyntropin. At this time, no other studies have demonstrated that VEGF is responsive to ACTH in humans. If the hypothesis is correct, the results will have two main implications. VEGF can be used as a marker of ACTH administration during the LDAST to identify false positive tests. Secondly, this will help further research into whether ACTH can be used to protect against bone disease in high-dose steroid-treated patients. Further studies can be done to assess whether this effect will be the same in patients with AI or steroid-induced adrenal suppression.
Osteoporosis prevention is important in patients with osteopenia (low bone density). This study will test the safety and efficacy of zoledronic acid in patients diagnosed with osteopenia.
RATIONALE: Zoledronate may reduce bone loss in patients receiving letrozole for breast cancer. PURPOSE: This clinical trial is studying how well zoledronate works in treating osteopenia or osteoporosis in postmenopausal women receiving letrozole for stage I, stage II, or stage IIIA primary breast cancer.
To assess the effectiveness of 16bit's Rho AI (artificial intelligence) software at identifying known cases of osteoporosis. 800 de-identified images from January 2007 to January 2024 will be accessed to test the software prospectively.
The goals of this study are 1) to investigate the extent to which dried plum improves bone health by measuring bone density (a measure of bone strength) of whole body, hip, and forearm, indicators of bone formation and bone breakdown, and 2) to determine the anti-inflammatory effects of dried plum by assessing biomarkers of inflammation. Additionally, relevant medical history and lifestyle variables will be recorded.
The purpose of this study is to determine the effects of Moringa Oleifera on the structure and function of bone in post-menopausal women ingesting 1000 mg of Moringa Oleifera daily for 12 weeks.
The purpose of this study is to apply a novel advanced magnetic resonance imaging methodology to evaluate the response to drug intervention involving two treatment arms of postmenopausal participants with osteoporosis, randomized into either a teriparatide (Forteo™) or zoledronic acid (Reclast™) group.
Osteoporosis is a disease characterized by low bone mass and structural deterioration of bone tissue leading to bone fragility (i.e., weakness) and an increased risk for fracture. Bone strength is a critical factor in a bone's ability to resist fracture and is clearly an important outcome in studies of osteoporosis. The current standard for assessing bone health and diagnosing osteoporosis is to use dual-energy x-ray absorptiometry (DXA) to quantify the areal bone mineral density (BMD), typically at the hip and spine. However, DXA-derived BMD has limited discriminatory accuracy for distinguishing individuals that experience fragility fracture from those who do not. One well known limitation of DXA-derived BMD is that it does not adequately assay bone strength. There is a critical unmet need to identify persons more accurately with diminished bone strength who are at high risk of experiencing a fragility fracture in order to determine an appropriate therapy. A potential new diagnostic approach to assess skeletal health and improve osteoporosis diagnosis is the use of Cortical Bone Mechanics Technology (CBMT). CBMT leverages multifrequency vibration analysis to conduct a noninvasive, dynamic 3-point bending test that makes direct, mechanical measurements of ulnar cortical bone. Data indicates that CBMT-derived ulnar flexural rigidity accurately estimates ulnar whole bone strength and provides information about cortical bone that is unique and independent of DXA-derived BMD. However, the clinical utility of CBMT-derived flexural rigidity has not yet been demonstrated. The investigators have designed a clinical study to assess the accuracy of CBMT-derived ulnar flexural rigidity in discriminating post-menopausal women who have suffered a fragility fracture from those who have not. These data will be compared to DXA-derived peripheral and central measures of BMD obtained from the same subjects.
In the context of male osteoporosis, we hypothesize that regional changes in trabecular bone, as well as changes in cortical porosity will play a major role, and thus also affect bone strength. In developing therapeutics the response of individual compartments, regional variations post-therapy will have considerable impact on selecting the therapies as well as monitoring response to therapy. This study, a precursor to other therapeutic trials, will lay the ground-work for the future.
The purpose of this trial is to study the clinical safety, tolerability, and efficacy of zoledronic acid compared to an oral bisphosphonate in postmenopausal women with osteoporosis.
The purpose of this study is to assess bone mineral density in patients switching from an oral bisphosphonate to zoledronic acid, compared to those staying on the oral bisphosphonate.
This study will investigate participant satisfaction (including compliance, preference, tolerability) with once-monthly Bonviva in women with post-menopausal osteoporosis or osteopenia transitioned from once-weekly alendronate or risedronate. The anticipated time on study treatment is 6 months, and the target sample size is 1776 individuals.
The purpose of this study is to evaluate treatment adherence to different regimens of ibandronate in postmenopausal women with osteoporosis or osteopenia who are intolerant to daily or weekly alendronate or risedronate therapy due to gastrointestinal (GI) side effects. The anticipated time on study treatment is 12 months, and the target sample size is 517 individuals.
The aim of the 2 month randomized controlled trial is to investigate the feasibility of a novel progressive muscle resistance exercise in individuals with low bone mass.
Models of Osteoporosis Screening in Male Veterans aims to test 1 distinct care model of primary osteoporosis screening in men within the VA healthcare setting. All care models deliver VA recommended osteoporosis screening and treatment to high-risk Veterans by appropriate Durham VA clinical staff. The MOPS project will evaluate patient, provider and facility outcomes to determine the effectiveness of each intervention.
This Phase II trial studies the side effects of denosumab and to see how well it works in treating patients with bone loss who have received a donor stem cell transplant. Patients receiving a donor stem cell transplant may experience accelerated bone loss and an increase risk of bone fractures, leading to a decrease in satisfaction and quality of life. A type of immunotherapy drug called denosumab binds to a protein called RANKL, which may help keep bone from breaking down.
A Phase 1 Randomized, Double-Blind, Placebo-Controlled Single and Multiple Ascending Dose Study of the Safety and Tolerability of Intravenous LLP2A-Alendronate in Adult Men and Women with Osteopenia Secondary to Corticosteroids
The purpose of this study is to identify the best way to prevent bone loss in the first years after menopause. The HOPS study will compare bone loss at 12 months in women: 1) who take calcium and vitamin D only; 2) who take calcium and vitamin D plus the medication "risedronate"; or 3) who take calcium and vitamin D plus participate in bone-loading exercises. Our central hypothesis is that improvements in bone health will be greater in women randomized to bone-loading exercises with calcium and vitamin D compared to women who take calcium and vitamin D only or women who take calcium and vitamin D plus risedronate.
This is a Phase 2, open-label, randomized, controlled clinical study of pediatric subjects treated with pamidronate with calcium and vitamin D versus calcium and vitamin D alone following hematopoietic cell transplantation (HCT). The purpose of this study is to test the hypothesis that subjects receiving pamidronate with calcium and vitamin D will have higher lumbar spine bone mineral content (LBMC) measured by dual-energy X-ray tomography (DXA) at 1 year post-HCT than subjects receiving calcium and vitamin D alone (Control Group).
The investigators' long-term goal is to employ novel methods to improve bone formation and bone density in women (and men) with osteopenia or osteoporosis while also decreasing signs and symptoms of degenerative joint and disc disease that commonly accompany bone loss as well as improve quality of life (QOL). These conditions generally begin silently as early as the menopause transition and progress to osteopenia and osteoporosis during the post-menopausal years in aging women. The investigators also envision this will be beneficial in aging andropausal men with these conditions. The investigators postulate that melatonin in novel combination with other natural bone-protective agents may act in a "chronosynergy" manner to prevent and correct these perturbations, reducing the risk of bone fractures, and lessening the stiffness and pain associated with bone, joint and cartilage degeneration and improving quality of life (QOL). The objective here, which is the investigators' next step in pursuit of our goal, is to assess the efficacy of an alternative therapy that uses a novel combination of bone-forming agents, melatonin, strontium (citrate)/ vitamin K2 (MK7), and vitamin D3 on bone health in a postmenopausal population. Melatonin is a novel alternative to current treatment(s) because it has multiple bone-protective and sleep-promoting activities within the body, and it is relatively safe so it can be used in an aging population without untoward side effects; strontium and vitamin D3 are shown to enhance bone mineralization and improve post-menopausal osteoporosis. The project goal is to identify if this combination therapy improves bone health and QOL compared to women taking placebo. The investigators' central hypothesis is that combination therapy using melatonin, strontium, vitamin K2, and vitamin D3 will improve bone health and overall QOL in postmenopausal women not taking this regimen by reducing osteoclast activity and increasing osteoblast activity and by improving subjective measures of stress, anxiety, depression and menopause-related symptoms.
The study seeks to determine the impact of assessing risk for osteoporosis in women on patient and physician behaviors through a pharmacist directed osteoporosis screening program. Women will be offered a heel ultrasound to screen for their bone density and may or may not be asked questions about their risk for bone fracture. Pharmacists will counsel and educate all women on ways to prevent the onset of osteoporosis. Women will be telephoned three months after the screening and asked a series of 10 questions to follow up on decisions made by their physicians or changes made to their health behaviors related to bone health.
This study is designed to provide information on the safety, tolerability, pharmacokinetics (PK) and bone biomarker response following multiple BPS804 administration in multiple dosing regimens. This information will permit a comparison of the possible risks and benefits of different dosing regimens of the study drug to enable optimal doses and dose intervals to be tested in subsequent studies.
Anorexia nervosa is an eating disorder that can cause thinning of the bones (a decrease in bone density). A significant decrease in bone density is called osteopenia or osteoporosis. Sometimes the loss of bone density can be severe enough to cause breaks and fractures of the bones. It is not known what causes the bones to thin in anorexia nervosa. Women who have this condition often have thin or weak bones that are more likely to break. They also have very low levels of a chemical called IGF-1 in their body. This chemical is very important for increasing bone growth in puberty and for maintaining healthy adult bones. The investigators would like to find out if giving rhIGF-1 followed by risedronate or risedronate alone can lead to an increase in bone formation, bone density, and bone strength in women with anorexia nervosa.
The purpose of this study is to determine the safety and tolerability of RN564 in women with osteopenia and healthy men.