Active clinical trials for "Osteoporosis"

This study will evaluate the effects of hormone replacement therapy on patients with Turner syndrome (TS)-a genetic disorder in females in which part or all of one X chromosome is missing. Most girls and women with TS have underdeveloped ovaries-the female reproductive organs that produce the female sex hormones estrogen and progesterone, and smaller amounts of the male sex hormone, testosterone. These hormones affect muscle and bone strength, sex drive, energy, and an overall sense of well being. Estrogen may also play a role in memory and mood and have a protective effect against heart disease. Women with TS have a much higher risk of developing osteoporosis (loss of bone density), high blood pressure, high cholesterol and diabetes than women without this disorder. Girls and women with Turner syndrome between the ages of 14 and 50 years may be eligible for this 2-year study. Three months before beginning treatment, all patients will wear an estrogen patch and take a progesterone tablet daily for 10 days each month. They will then be randomly assigned to one of two treatment groups to compare the effects of estrogen alone with estrogen plus testosterone on bone strength, muscle and fat mass and psychosocial well being. Both groups will wear an estrogen patch and take oral progesterone. One group will also wear a testosterone patch while the other group will wear a placebo patch (a patch that does not contain any testosterone). Neither study participants nor the doctors will know who is getting the testosterone until the study is complete. Patients will undergo the following procedures before beginning treatment and at 6, 12 and 24 months after starting treatment: Physical examination. DEXA scans (dual energy X-ray absorptiometry) to measure body composition and bone thickness. Low radiation X-rays scan the whole body to measure fat, muscle and bone mineral content.. Magnetic resonance imaging (MRI) scan of the abdomen to measure the amount of fat around the internal organs. The patient lies on a stretcher in a large tube surrounded by a magnetic field during the scanning. The procedure uses a strong magnet and radio waves to produce the images. Heel ultrasound to measure bone thickness. The heel is placed in a chamber and sound waves pass through it to produce images. Oral glucose tolerance test (OGTT) for diabetes and problems with carbohydrate metabolism. The patient drinks a sugary substance. A small amount of blood is drawn before taking the drink and four times afterwards. Blood and urine tests to measure blood counts, liver and kidney function, ovarian hormones, growth factors, thyroid function, blood lipids, bone strength markers, and to test for pregnancy. Blood pressure measurements. Psychological testing for the effect of treatment on mood, self-esteem, quality of life, social shyness, anxiety and sexual function. Neurocognitive tests (at first inpatient visit and 1 and 2 years after starting treatment) to measure nonverbal memory and visual-perceptual abilities. During the hospital admissions, patients will be given a "metabolic diet" that contains specific amounts of salt and carbohydrates to ensure accurate blood pressure and sugar metabolism measurements. Patients will keep a record of their menstrual periods and physical activity throughout the treatment period.

This 2 arm study will assess the long-term efficacy and safety of oral treatment with 100mg or 150mg Bonviva in women with post-menopausal osteoporosis who have previously completed Bonviva study BM16549 (MOBILE study). Patients will receive Bonviva either 100mg po monthly, or 150mg po monthly. Patients will also receive daily supplementation with vitamin D and calcium. The anticipated time of study treatment is 2+ years, and the target sample size is 500+ individuals.

Effects of Teriparatide in Postmenopausal Women Previously Treated with Alendronate or Raloxifene.

OBJECTIVES: I. Determine the bioavailability and biologic effect of alendronate on bone metabolism in patients with cystic fibrosis. II. Assess the safety and efficacy of this treatment regimen in improving osteoporosis in this patient population.

In contrast with bisphosphonates,discontinuation of denosumab results in gradual loss of bone mineral density gains. The investigators aim to evaluate whether in patients treated with denosumab, a single zoledronic acid infusion would prevent the anticipated bone loss.

Osteoporosis is a large public health disease, characterized by low bone mass and micro architectural deterioration of bone tissue, resulting in enhanced bone fragility and consequent increase in fracture risk. Osteoporosis is present when bone mineral density (BMD) or content (BMC), measured by dual-energy X-ray absorptiometry (DXA), is more than 2.5 SDs below the mean value of the young adult. BMD measured by DXA is a surrogate measure of bone strength and is the primary determinant of fracture risk in both men and women. However, the majority of fragility fractures occur in women and in individuals who do not have osteoporosis according to these standards, indicating that BMD is just one among several indicators of bone health and that assessment of fracture risk should also rely on other bone properties. Newer imaging methods, such as quantitative computerized tomography (QCT), can complement information from DXA-measurements due to its ability to assess volumetric BMD and bone geometry and to differentiate between cortical and trabecular bone compartments. Bones are composite materials made predominantly of living cells, extracellular matrix, water and lipids. This composite nature of the bone material enables it to absorb stresses by elastic deformation and to endure high loads before fracturing. A new in vivo measurements of bone material strength can be used to evaluate bone mechanical properties and thereby the fracture risk. It is well established that the skeleton benefits, in terms of increased density, from regular physical activity. However, changes in BMD are still the main surrogate for assessing improvements in exercise-induced bone health despite the experimental findings as well as findings in humans showing that improvements in mechanical bone properties are independent of changes in BMD. These improvements in mechanical bone properties may be due to changes in bone shape or matrix composition. It could then be argued that a decrease in BMD is only one of the possible manifestations of osteoporosis and that bone strength or fragility is multifactorial. The objective for this study is to investigate the role of mechanical loading on bone material strength and bone microarchitecture in middle-aged women. The overall hypothesis is that mechanical loading is a regulator of bone material strength and microarchitecture in middle-aged women. This is an intervention study where the participants will act as their own controls. The investigators intend to include 40 postmenopausal and healthy women 50-60 years of age in the study. Advertisements in local papers and at the hospital will be used to come into contact with suitable study subjects. The women will be asked to perform an intervention program, including jumping on one leg every day during a 3-month period according to a protocol with a gradually increasing load/number of jumps. The women have to choose one of their legs as intervention-leg and stick to the chosen leg throughout the study. The leg without intervention will be used as a control. Both bone material strength (BMS) and bone microarchitecture will be measured before and after intervention in both legs (tibia). The operators measuring BMS (OsteoProbe®) and bone microarchitecture (high resolution pQCT) will be blinded concerning each participant's choice of leg for intervention. In addition, subjects will be asked to register daily physical activity in a structured diary. The primary outcome measure will be changes in bone material strength (BMS) in the lower leg (tibia) with intervention compared to the leg (tibia) without intervention. Participants will attend two clinic visits, at baseline and after 3 months when the intervention period is completed. The secondary outcome measures will be changes in total volumetric density, cortical volumetric density, cortical cross sectional area and trabecular bone volume fraction in the lower leg (tibia) with intervention compared to the leg (tibia) without intervention.

Fractures related to skeleton fragility (i.e. osteoporotic fractures) represent a growing health problem, as the life expectancy and thus the number of frail elderly subjects is increasing. These fractures are associated with individual and societal consequences. The fractures are responsible for increased disability, chronic pain, and loss of independency. The annual cost of either prevalent or incident osteoporotic-related fractures exceeds the same ratio calculation for many other serious chronic diseases. Mortality risk is increased following osteoporotic fractures. Several classes of osteoporosis therapies are proven to reduce fracture risk, based on placebo controlled trials of 3-5 years duration, including in elderly patients. These data are the rationale for screening of patients at risk of fracture, recognizing that the optimal approach is to identify subjects at risk for major fractures . Bone fragility is related to the decrease of both the quality and the quantity of bone. Bone mineral density (BMD) is a surrogate of bone fragility, with the advantage of being non-invasively measurable, at relevant sites, such as vertebrae and upper extremity of the femur. A low BMD, age, and prevalent fractures are the 3 main determinants of the risk of sustaining a fracture. A low BMD has also been reported as a determinant of all cause mortality risk in the general population. So far, screening of low BMD by QCT has not been recommended because of low availability of the devices, irradiation, and cost. However, a huge number of QCT are performed daily for various medical indications. These thoracic and abdominal QCT carry potential information about vertebral BMD. These data are already available, with no additional cost, patient time, nor radiation exposure. They can be retrospectively (in our study) or prospectively (in the future context of care) analyzed, and are the basis of an opportunistic screening for osteoporosis: this denotes the use of diagnostic QCT scans made for other medical indication to screen for patients at high fracture risk. There is no study of this QCT based measurement as an opportunistic screening for patients at short-term risk for fracture. Opportunistic screening of osteoporosis, by diagnosis of low BMD on abdominal QCT performed for various medical indications, is able to detect subjects at short-term (i.e. over 3 years) risk of fracture (necessitating an hospitalization).

Patients with primary hyperparathyroidism (pHPT) with osteopenia and osteoporosis are treated with strontium ranelate/Ca+Vitamin-D or placebo/Ca+Vitamin D after successful surgical treatment of pHPT. Strontium ranelate/Ca + Vitamin-D helps to regain bone mass in patients with osteopenia or osteoporosis after successful parathyroidectomy for pHPT and results in higher gain of BMD than placebo treated patients.

In a randomized, double-blind trial, BMD of the operated proximal femur after total hip replacement measured by dual-energy x-ray absorptiometry (DXA) were compared for up to two years in patients receiving IV ZOL 5 mg infusion (n = 27) or placebo (IV saline infusion; n = 24) at two weeks and one year after surgery.

This study will examine the biological fate of radioactive SB-751689 administered to healthy males and healthy postmenopausal women. Subjects will receive a single oral dose of radioactive SB-751689. Excreta and blood samples will be taken over the course of 7 days. This study will help determine the major route of elimination of SB-751689 in humans. It will also provide samples (blood, plasma, urine, and stools) for analysis of metabolites, if any.