Active clinical trials for "Bone Diseases, Metabolic"

Resistance training as well as creatine supplementation may increase bone mass. Therefore, the investigators speculate that resistance training combined with creatine supplementation would promote additive benefits on bone mass in elderly women with osteopenia and osteoporosis.

This is a Phase 1, double-blind, placebo-controlled, repeated-dose study to assess the safety, tolerability, and preliminary effects of CHI-554 in postmenopausal women ages 50-80 years who have osteopenia.

Osteoporosis is an important health problem in the rapidly-aging demographic. Fragility fractures are devastating consequences of osteoporosis. The most common treatment approach in osteoporosis is inhibition of bone resorption with drugs like alendronate (ALN). Parathyroid hormone (PTH) stimulates bone formation and is the only anabolic drug available. Dual therapy with ALN and PTH is not as effective as single-drug therapy in preventing fracture. Bone progenitor cells (MSCs) are recruited to sites of bone remodeling when a growth factor called Transforming Growth Factor Beta (TGF-β1) is released from bone. Different osteoporosis medicines may have differing effects on this process. The effects of ALN versus PTH on bone progenitor recruitment in humans are unknown. This is a randomized, clinical trial of ALN, PTH, and calcium and vitamin D in post-menopausal women with low bone mass. Women will be treated for 3 months with ALN or PTH or calcium and vitamin D. Data collected will include bone biopsies for histomorphometry and micro computed tomography (µCT), bone marrow aspirates for molecular studies, peripheral blood to detect circulating bone progenitor cells and dual X-ray absorptiometry. The investigators hypothesize that in humans, PTH will 1) increase bone progenitor number, 2) enhance recruitment of bone progenitor cells to bone resorption sites, and 3) increase bone progenitor number in peripheral circulation. Furthermore, the investigators hypothesize that ALN treatment will have the opposite effect. Understanding the differences in bone progenitor cell activity and recruitment during osteoporosis therapy will provide a mechanistic rationale for effective use of PTH and anti-resorptive drugs in osteoporosis treatment.

There is a well-documented increased risk for disordered mineral bone homeostasis in Kidney Transplant Recipients (KTRs) when compared to the general population, leading to a markedly increased risk for fragility fractures and their associated morbidity and mortality. A more uniform and rigorous evaluation of bone and mineral homeostasis,than is afforded to patients under "normal care", will result in better clinical outcomes in KTRs.

The project goal is to identify if herbal teas consumed three times per day over a period of three months can improve these markers of bone health as well as improve quality of life (QOL) compared to women taking placebo by increasing osteoblast activity, decreasing osteoclast activity, increasing nocturnal melatonin levels and by decreasing C-reactive protein (CRP) and cortisol levels. Our central hypothesis is that these herbal teas will improve both objective and subjective measures of bone health in a population with osteopenia not taking this regimen by reducing osteoclast activity and increasing osteoblast activity and by reducing stress and anxiety.

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).

Losses of muscular fitness/balance are common occurrences with aging that can lead to an increased fall-risk. The accelerated bone loss that may accompany menopause makes some women even more "at-risk" for serious consequences related to falling. Interventions to reduce fall-risk have been conducted in an attempt to improve balance or muscular fitness, but often these interventions require monotonous exercises that don't arouse enough long-term interest to elicit the improvements. In other words, while the intervention may be beneficial, participants quit before they can realize any gains. Currently, there is little research that uses novel technology-based programs to promote balance exercises among middle-aged women. The Wii Fit system includes various strength and balance exercises integrated into games intended to have the participant have fun and retain interest, while also improving fitness. By using such a program, women could potentially improve their balance and decrease their fall risk in a way that is fun and exciting. The purpose of this study is to investigate the effect of a Wii Fit based exercise program on balance/muscular fitness/markers of bone health in women between the ages of 45-60 with low bone mass. Volunteers who have moderately low bone levels (n = 28) will be randomly assigned to either the Wii Fit exercise intervention or a normally active control. Balance ability, muscular fitness, body composition, physical activity levels and markers of bone health will be assessed before and after the intervention. Each participant in the intervention will be provided a pre-programmed Wii Fit console and balance board to use at home. The intervention will consist of a 12-week program that they perform 30 minutes a day 3 days a week. The exercises include 10 minutes of Yoga poses and strength exercises and then 20 minutes of balance games such as soccer heading, ski slalom and table tilt. At the 6 week point and the conclusion of the intervention, participants will come to the lab for testing on the same tests done initially. The overall goal of this study is to gauge the efficacy of this intervention to improve balance, fitness, and bone health in at-risk women. This project is important because it offers an exciting, fun, and motivating way to impact fall-risk before clinical symptoms develop. Overall, this intervention could significantly reduce healthcare dollars spent on fall-related outcomes, as well as reduce fall-related mortality.

Osteoporosis is one of the most common skeletal disorders. Today in the United States, 10 million individuals have osteoporosis and 34 million more have low bone mass or osteopenia, which places them at an increased risk of some day developing osteoporosis. Of the people affected by this problem, 68% are women.The current thinking on the development of osteoporosis is that the changes in bone turnover that occur with aging play a major factor. Many modalities of treatment are used to prevent the bone loss and increased fracture risk associated with osteoporosis and osteopenia. Melatonin supplementation may be another treatment modality that lowers risk of hip fracture in perimenopausal women. Melatonin can remodel bone in animal models and in culture. Melatonin works through melatonin receptors to form osteoblasts from human mesenchymal stem cells and has been shown to inhibit osteoclast activity in rodents. Melatonin levels have been correlated with modulating bone markers; low nocturnal levels of melatonin correlate with in an increase in bone marker metabolism and osteoporosis. It is been shown that women who have worked night-shifts for greater than 20 years have increased risk for wrist and hip fractures. Night-shift workers have lower nocturnal melatonin levels than people who do not work the night-shift. The addition of exogenous melatonin suppresses bone marker metabolism. In human stem cells taken from bone marrow, melatonin increases the activity of bone-forming cells called osteoblasts. It is hypothesized that melatonin will improve bone health, menopausal quality of life and sleep compared to placebo in perimenopausal women. In particular, the investigators expect perimenopausal women taking melatonin to show an improvement in overall bone health as revealed by a reduction in bone marker turnover since bone resorption increases more so than bone absorption in this population compared to those women taking placebo. We also expect that perimenopausal women taking melatonin to have better control over their menopausal symptoms, better quality of life and less sleep disturbances when compared to their placebo controls since melatonin is known to modulate estrogen levels in the body and regulate sleep. The data from these studies may provide novel and alternative uses for melatonin; in particular its use for the prevention and/or treatment of osteoporosis.

The purpose of this study is to determine whether the intake of a daily dosage of standardized olive extract provides any protection against bone loss.

The primary objective of this clinical trial is to determine the effects of hesperidin on biochemical markers of bone in post-menopausal women. The secondary objectives are: To investigate changes in bone formation and bone resorption markers in response to hesperidin intake To compare the efficacy of hesperidin in a milk versus biscuit To collect safety information of hesperidin consumption in a human trial