Treatment Trials

309 Clinical Trials for Various Conditions

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NOT_YET_RECRUITING
Romosozumab Effects on Bone Density, Muscle Mass, and Spine Surgery Outcomes
Description

The goal of this clinical trial is to learn if romosozumab (Evenity) can improve bone and muscle health in postmenopausal women with osteoporosis who are undergoing lumbar spine surgery. The main questions it aims to answer are: * Does romosozumab improve bone strength and reduce the risk of complications during and after spine surgery? * Does romosozumab increase muscle mass and help patients recover better from surgery? Researchers will compare romosozumab (a monthly injection) to alendronate (a weekly pill), both approved treatments for osteoporosis, to see which is more effective in this surgical setting. Participants will: * Be randomly assigned to receive romosozumab or alendronate * Take standard vitamin supplements and receive a one-time dose of zoledronic acid near the end of the study * Attend five study visits over about 12 months * Undergo bone scans, muscle imaging, and complete health questionnaires before and after surgery

RECRUITING
A Trial Evaluating Efficacy of AGA2118 in PostMenopausal Women wIth Low Bone MasS (ARTEMIS)
Description

The primary objective of this study is to determine the effect of treatment with AGA2118 versus placebo at Month 12 on lumbar spine bone mineral density (BMD) in postmenopausal women with low bone mass.

TERMINATED
Effect of Pradaxa vs Warfarin on Bone Mass and Bone Turnover Markers
Description

The investigators are evaluating the effect of Pradaxa in comparison to warfarin on bone turnover and bone density in men and women with atrial fibrillation.

WITHDRAWN
A Phase IIa Study of Sotatercept on Bone Mass and Turnover in Patients With Multiple Myeloma
Description

Lytic bone disease continues to be one of the most devastating complications of multiple myeloma (MM) despite recent and dramatic advancements in MM management, and bone lesions persist and can continue to significantly impact a patient's morbidity, even when an individual's myeloma is otherwise under good control. To date, no agent has been shown to have a prolonged bone anabolic response in myeloma. Preliminary studies treating healthy postmenopausal women with a single dose of sotatercept demonstrated a rapid and sustained increase in serum biochemical markers of bone formation and a decrease in markers of bone resorption. Similarly, the murine analog to sotatercept, RAP-011, increases bone mineral density and strength in murine studies of both normal animals and models of bone loss. We hypothesize that sotatercept will provide an anabolic response for bone in myeloma patients with bone disease.

COMPLETED
Bone Mass and Strength After Kidney Transplantation
Description

The purpose of this study is to test whether active vitamin D (calcitriol) protects bones from weakening and protects blood vessels from calcium deposits over the first year of kidney transplantation.

COMPLETED
Do Serotonin Reuptake Inhibitors (SSRIs) Affect Bone Mass in Adolescents
Description

Building on findings from animal studies, pediatric clinical trials, epidemiologic research in adults, and on preliminary findings from the investigators' laboratory in children and adolescents, this project aims to investigate whether selective serotonin reuptake inhibitors (SSRIs), a group of widely-used psychotropics, are associated with impaired bone mineralization in youths. Establishing such an association is a first step in a process that would eventually involve developing preventative interventions. Identifying genetic factors that place certain youths at higher risks for this side effect would ultimately allow clinicians to tailor treatment to the needs and vulnerabilities of each youth, moving the field closer towards individualized medicine.

TERMINATED
The Effects of Estrogen Replacement Therapy in Postmenopausal Women With Hypercalciuria and Low Bone Mass
Description

The purpose of this study is to assess if estrogen replacement normalizes urinary calcium excretion in postmenopausal women with hypercalciuria and low bone mass and to assess for differences in response to estrogen replacement in women with familial hypercalciuria compared to nonfamilial hypercalciuria.

COMPLETED
To Learn How Bone Structure and Bone Mass Change After Long-term PPI Use
Description

Patients with severe acid reflux and/or Barrett's esophagus are recommended to take Proton pump inhibitors (PPIs)indefinitely to prevent complications such as strictures or the development of a type of esophageal cancer. Recently, some studies suggested that taking these medications on a long-term basis may affect the bone. Therefore, it is important to learn whether these medications may lead to accelerated bone loss so that effective preventive measures can be developed for patients who require these medications for acid-related conditions. Several studies reported that patients receiving PPIs for many years may have increased risk of hip fractures. However, it is unclear whether this is because the PPIs cause reduced bone density or whether the increased risk of fractures has nothing to do with PPIs and is because patients who require PPIs have other illnesses that cause the increased fractures. The purpose of the study is to learn how bone structure and bone mass change after long-term PPI use.

COMPLETED
Effects of Anorexia Nervosa on Peak Bone Mass
Description

Teenage girls with anorexia nervosa (AN) are at risk for low bone density and low rates of bone accrual, raising concerns regarding acquisition of peak bone mass, an important determinant of future bone health and fracture risk. Important factors contributing to low bone density in AN include low levels of estrogen and insulin like growth factor-1 (IGF-1). While estrogen is important for preventing bone loss, IGF-1 is important for optimizing bone formation. We have shown in a previous study that replacement of estrogen is effective in increasing bone density in teenage girls with AN; however, this increase in bone density remains lower than that seen in normal-weight controls over the same duration, and residual deficits persist. Importantly, the impact of administering replacement doses of IGF-1 with estrogen replacement has not been studied in teenagers with AN. This study will examine the impact of administering recombinant human (rh) insulin like growth factor-1 (rhIGF-1) with estrogen (to mimic pubertal levels of these hormones) versus administration of estrogen alone on bone metabolism in adolescent girls with anorexia nervosa (AN). One aim of this proposal is to investigate whether co-administration of insulin like growth factor-1 (rhIGF-1) with physiologic estradiol replacement to adolescent girls with AN will increase BMD (bone mineral density) more than estrogen monotherapy, and whether bone mass will approach that seen in healthy adolescent girls. An additional aim is to determine whether co-administration of rhIGF-1 with estradiol to mimic the normal pubertal milieu stimulates bone formation through an IGF-1 mediated anabolic effect, increases bone density to a greater extent than estrogen monotherapy, and improves bone mass accrual to approach that in healthy controls. The impact of rhIGF-1 +estradiol versus estradiol alone on bone microarchitecture will also be assessed.

COMPLETED
Effect of Teriparatide, Vibration and the Combination on Bone Mass and Bone Architecture in Chronic Spinal Cord Injury
Description

Spinal cord injury (SCI) results in marked acute loss of bone. This study evaluates the effect of teriparatide (PTH) and the use of vibration as a form of mechanical stimulation on bone mass.

COMPLETED
Low Energy Availability, Menstrual Irregularity, and Low Bone Mass
Description

This study examines the role of energy availability on menstrual function and bone mass in female adolescent endurance athletes. Specific evaluations include dietary intake, exercise energy expenditure, training schedules, menstrual function and bone density.

COMPLETED
A Study That Will Compare the Effect of Two Drugs on Participants With Low Bone Mass and a Recent Hip Fracture
Description

This study will evaluate whether teriparatide is superior to the active comparator in the change from baseline of lumbar spine BMD (bone mineral density) in men and postmenopausal women with low bone mass and a recent pertrochanteric hip fracture.

Conditions
COMPLETED
Effect Of Risedronate On Bone Mass In Older Men Receiving Neoadjuvant Therapy For Prostate Cancer
Description

Men treated with neoadjuvant luteinizing hormone-releasing hormone (LHRH)-agonists such as leuprolide and goserelin for prostate cancer will become hypogonadal due to hormonal suppression and demonstrate increased bone turnover and consequent bone loss at the hip and spine. This bone loss can be prevented by treatment with 35 mg/week of risedronate.

Conditions
WITHDRAWN
Bone Mass Accrual in Adolescent Athletes
Description

The adolescent and young adult years are a critical window in time for bone mineral accrual. More than 90% of peak bone mass is achieved by 18 years, and data indicate that insults sustained during adolescence and young adulthood may result in permanent deficits in bone accrual. Adult athletes with amenorrhea (AA) have low bone mineral density (BMD) secondary to hypogonadism, associated with increased fracture risk and associated co-morbidities. We will examine whether estrogen replacement will increase BMD and improve measures of bone microarchitecture in adolescents and young women with AA, thus optimizing peak bone mass.

COMPLETED
Calcium and Vitamin D to Optimize Bone Mass in Boys With Risperidone-induced Hyperprolactinemia
Description

The purpose of this study is to determine whether calcium and vitamin D supplementation, over a nine-month period, optimizes bone mineralization in boys with risperidone-induced hyperprolactinemia. We hypothesize that, by the end of the stuy, children in the supplementation group will have higher bone mineral density compared to those in the placebo group.

COMPLETED
The Role of Parathyroid Hormone (PTH) in Low Bone Mass in Anorexia Nervosa
Description

Decreased bone strength is a common and serious medical problem present in many women with anorexia nervosa, or disordered eating. Women with decreased bone strength are more likely to suffer broken bones than women with normal bone strength. We are investigating whether a hormone that is naturally produced by the human body -- parathyroid hormone (PTH) -- can help strengthen the bones of women with anorexia nervosa.

UNKNOWN
Cyclic Versus Daily Teriparatide on Bone Mass
Description

Osteoporosis is a disease that affects millions of individuals in the United States and abroad. It leads to decreased bone mass and causes an increased risk of fracture. This study will compare continuous versus cyclic treatment with teriparatide combined with alendronate, another drug for osteoporosis, or teriparatide alone in women with osteoporosis.

Conditions
COMPLETED
The Effect of Dairy on Bone Mass and Body Composition in 4th-8th Grade Boys and Girls
Description

Building stronger bones during pubertal growth could reduce lifelong fracture risk. This project is an 18 month dairy intervention study for overweight and healthy weight 4th-8th grade boys and girls. Half of the girls will receive dairy products to add to their habitual diet (milk, yogurt, and cheese) to equal three products per day, while the other half will remain on their normal diet. All participants will attend four study visits, each 6 months apart. At these visits height, weight, bone density and geometry, and fat and lean mass will be measured. This study aims to show that meeting calcium requirements by eating dairy products builds bigger, stronger bones, and that this effect may be enhanced in overweight boys and girls. The effect of the dairy intervention on body fat, lean mass, and weight, as well as the mechanisms and predictors of changes in bone mass and size and body composition will also be evaluated.

Conditions
COMPLETED
Efficacy of Plyometrics to Increase Bone Mass in Men With Osteopenia
Description

This study will compare the ability of two types of long term (12 months) weight-bearing exercise treatments (1. high-intensity jumping and 2. weight lifting) to increase bone mass of the total body, spine and hip in physically active men with osteopenia.

Conditions
COMPLETED
Acetaminophen or Fluvastatin Compared to Placebo on the Transient Post-Dose Symptoms (PDS) Following an Intravenous (i.v.) Infusion of a Single Dose of Zoledronic Acid 5mg, in Post-menopausal Women With Low Bone Mass
Description

This study will evaluate the efficacy of acetaminophen or fluvastatin in reducing the rate of occurrence and the severity of post dose symptoms that may occur during the 3 day period following a zoledronic acid infusion in post menopausal women with low bone mass.

Conditions
COMPLETED
Effects of Anorexia Nervosa on Bone Mass in Adolescents
Description

This study is to determine the effects of anorexia nervosa on bone mass and hormone levels in adolescents. Whether administration of estrogen, a normal hormone present during puberty, can help maintain bone development in girls with anorexia nervosa will be determined.

COMPLETED
Effects of Arzoxifene on Bone Mass and the Uterus
Description

The purposes of this study are to determine: * The effects of arzoxifene on bone mineral density (bone mass) at the spine and hip in postmenopausal women. * The effects of arzoxifene on the uterus (womb) in postmenopausal women. * The effects of arzoxifene on blood tests that measure changes in bone rebuilding in postmenopausal women with low bone density. * The effects of arzoxifene on blood lipids (fats) and other blood markers of heart disease risk. * The safety of arzoxifene and any side effects that might be associated with its use.

TERMINATED
An Investigation Into the Short Term Effect of APOMINE in Patients With Osteoporosis or Low Bone Mass
Description

Osteoporosis affects millions of postmenopausal women in the USA. The current approved treatments are all drugs that prevent bone loss and possibly result in small gains in bone mass. Another possible treatment consists of drugs that increase bone formation. There are currently two drugs that stimulate bone formation, sodium fluoride and human parathyroid hormone (hPTH). Neither of these two drugs has been approved by the FDA. APOMINE has shown significant bone formation in animal studies. In this study we plan to test whether APOMINE is able to stimulate new bone formation in women with osteoporosis or low bone mass.

Conditions
COMPLETED
Study of Low Bone Mass in Premenopausal or Perimenopausal Women
Description

OBJECTIVES: I. Determine the possible causes of bone loss in premenopausal or perimenopausal women.

Conditions
COMPLETED
Bone Mineral Density in Women With Major Depression
Description

The purpose of this study is to examine calcium absorption and bone mineral density in women with depression. Research indicates that pre-menopausal women with depression have significantly lower bone mineral density (BMD) than pre-menopausal women without depression. Although the mechanisms of BMD loss are unclear, researchers believe that individuals with depression have impaired calcium absorption. However, it is unknown whether the abnormal absorption is a result of depression or a side effect of the drugs used to treat it. This study will compare calcium absorption in women with depression and in healthy women without depression. Participants in this study will be given two non-radioactive calcium isotopes. One can be taken by mouth and the other must be injected. Participants will have the level of isotopes in their urine measured to estimate true fractional calcium absorption (TFCA). Participants may also have a dual X-ray absorptiometry (DEXA) scan to measure total body adiposity and lean body mass.

COMPLETED
Calcium and Bone Mass in Young Females
Description

We originally suggested that calcium in the diet is important in determining the amount of bone (bone mass) that builds up in young adults. We are testing the effect of calcium on bone mass in 354 Caucasian (white) girls. At the start of this 7-year study, the average age of the girls was 11 years, and they had not yet reached puberty. The study will also provide information about the effect of calcium on body composition (body fat) and blood pressure in young women. We have been giving calcium to one group of participants in this study and giving a placebo (an inactive pill, or "sugar pill") to the other group. The results of this research will be important in preventing osteoporosis, because building more bone as a young person should reduce a woman's chances of developing osteoporosis later in life.

Conditions
RECRUITING
Bone Mineral Density Precision Study
Description

The purpose of this research is to collect medical imaging data to allow for the comparison of bone mineral density measurements from two low-dose x-ray exams. The main question it aims to answer is: What is the precision measurement between the BMD assessments from 2 x-ray exams?

NOT_YET_RECRUITING
Feasibility of At-Home Chair-Based Resistance Band Training to Improve Balance, Strength, and Bone Density in Older Adults
Description

The purpose of this study is to determine the feasibility of implementing a 24-week at-home chair-based resistance band training intervention, to determine effectiveness of a the a 24-week at-home chair-based resistance band training intervention in improving body composition and to determine the effectiveness of a 24-week at-home chair-based resistance band training intervention in improving physical performance in adults 50 years and older, receiving care at the UT Physicians Center for Healthy Aging.

RECRUITING
Bone Mineral Density Agreement Study Between EOSedge™ Versus Traditional DXA
Description

The purpose of this research is to collect medical imaging data to allow for the comparison of bone mineral density measurements from two different types of low-dose x-ray exams, EOSedge and conventional DXA. The main question it aims to answer is: Is there agreement between the calculated T-scores between the 2 different types of x-ray exams?

RECRUITING
A Phase 3B Study to Evaluate Bone Mineral Density with Long-Term Use of Relugolix Combination Tablet in Women with Uterine Fibroids or Endometriosis
Description

The purpose of this clinical trial to characterize changes in bone mineral density during continuous treatment with relugolix combination tablet for up to 48 months (4 years) and 1 year of post-treatment follow-up in premenopausal women with heavy menstrual bleeding associated with uterine leiomyomas (fibroids) or with moderate-to-severe pain associated with endometriosis.