View clinical trials related to Osteoporosis.
Filter by:Vitamin D is a hormone that is produced when sunlight is absorbed by the skin. Vitamin D insufficiency has been recognized as a problem in areas where sun exposure is limited, especially in the wintertime. In addition, the more pigmented the skin is, the less capable it is of utilizing sunlight to make vitamin D. Vitamin D plays an important role in helping the body absorb calcium and in building strong bones. It has also been shown to improve muscle function in the elderly. As we get older, our vitamin D levels in the blood go down and this may increase the risk for falls and fractures. If we can improve vitamin D status as we age, we may be able to improve muscle strength and decrease the risk of falls and fractures.
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 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 NCIC CTG was conducting an international breast cancer prevention trial (MAP.3) examining the effects of a new therapy (exemestane) for breast cancer prevention in postmenopausal women at increased risk of developing this disease. Results showed that after a median follow up of 35 months, exemestane was superior to placebo in breast cancer prevention. Exemestane blocks estrogen production, which may be beneficial for preventing breast cancer, but may have negative effects on bone. As postmenopausal women are at risk for developing osteoporosis, determining whether exemestane causes bones to weaken is crucial for women considering it for long-term use. Dr. Cheung's team followed the bone health of 354 women in MAP.3 in detail over 2 years and found that volumetric bone mineral density (by high resolution peripheral quantitative computer tomography (HR-pQCT) at the radius and tibia as well as areal bone mineral density by dual energy x-ray absorptiometry (DXA) at the hip and spine decreased significantly with the use of exemestane. The long term effects of exemestane on bone will be examined up to 5 years of therapy and then 2 years post therapy to delineate the effects of exemestane on bone strength. This research will inform us on the safety of exemestane for breast cancer prevention.
The primary objectives of this study include evaluating the dose response of LY2541546 using bone mineral density (BMD) change from baseline as compared to placebo and evaluating the overall safety and tolerability of LY2541546 following multiple subcutaneous administrations in postmenopausal (PMP) women with low BMD. Following the last dose of study drug, participants will be able to participate in a 12 month extension to collect additional safety and efficacy data (no further treatment will be administered during this extension).
An Italian Multicentric randomized, open-label therapeutic trial evaluating the efficacy and safety of Neridronate in the treatment of Osteoporosis in patients with Thalassemia Major and Severe Thalassemia Intermedia. Efficacy and safety of the drug will be evaluated measuring at every visit this parameters: - haematological: Haemochrome - blood chemistry: creatinine, BUN, AST, ALT, Ca, P, proteins electrophoresis, total proteins. The prevalence of ectopic calcification and pseudoxantoma elasticum (PXE)-like syndrome and their follow-up will be evaluated at the beginning of the study vs 24 months through physical examination, abdominal echography and fundus oculi examination. During the trial other known risks factors for osteoporosis will be recorded, including prevalence and incidence of bone fractures and, if executed, Polimorphisms COLIA1. At the beginning of the study and at months 12 and 24 morphometry DXA will be performed to evaluate of the presence of bone deformities. Furthermore data regarding QOL and symptom pain will be evaluated trough administration of scale SF-36. At 12 months an intratrial analisis will be performed on efficacy and safety parameters in order to introduce possible amendments to the study design and to decide the prosecution of the trial During the trial all adverse events will be recorded
Rationale: Mechanical loading is well-known to have a strong anabolic effect on bone. It has therefore been proposed that a mechanical intervention could be an effective non-pharmacological approach to treat bone loss associated with conditions such as osteopenia and osteoporosis. Data from in vitro experiments indicate that the purine nucleotide adenosine 5'-triphosphate (ATP) is released by bone cells and mediates cellular crosstalk via P2 purinergic receptors in response to mechanical stimulation. ATP release by bone cells may thus be part of a general mechanism by which mechanical loading ultimately results in increased bone formation, but this remains to be investigated in humans in vivo. The investigators hypothesize that a mechanical intervention in humans leads to a rise in systemic ATP concentrations due to ATP release from bone. Objective: To investigate in vivo whether a measurable increase in systemic ATP levels occurs in response to mechanical stimulation of bone in humans. Study design: Intervention study with a non-randomized, non-blinded design. All subjects will participate in a single experiment, lasting approximately 3 hours, during which the subjects will receive a mechanical intervention at a fixed dose. Study population: Maximally 10 healthy human volunteers (18-35 y). Intervention: Subjects will receive a gentle and safe mechanical intervention, which will be administered by means of a Juvent 1000 Vibration Platform delivering low-magnitude mechanical stimuli (i.e. vibrations) to the forearm. The mechanical stimulation will be administered at a frequency of 90 Hz and amplitude of 10 µm in an intermittent fashion, i.e. three 10-minute periods of stimulation with 10-minute rest periods in between. Main outcome parameters: As the primary outcome parameter, a change in extracellular ATP concentrations as a result of the mechanical intervention will be assessed systemically.
This observational study will assess the compliance and persistence of patients, real life efficacy and safety of intravenously quarterly administered 3 mg ibandronate [Bonviva/Boniva] in comparison to oral alendronate generics in female patients with post-menopausal osteoporosis. The anticipated time of assessment is 12 months. The target sample size is 5000-7000 patients.
The Cohort of Swedish Men began in 1997, when all men born between 1918 and 1952 and residing in two counties in central Sweden received a questionnaire including about 350 items concerning diet and other lifestyle factors. A second questionnaire was sent out in 2008-09.
The Swedish Mammography Cohort began in 1987-1990, when 66,651 women living in two counties in central Sweden completed a mailed questionnaire that included items about their diet, parity, age at first child's birth, history of breast cancer in family, weight, height, and education. Follow-up questionnaires have been sent out in 1997 and in 2008-09.