View clinical trials related to Osteoporosis.
Filter by:Determine the safety of 2MD, a vitamin D analog, when administered orally once daily for 28 days in healthy normal postmenopausal women.
Bone health is a significant public health issue in the United States. An estimated 10 million Americans age 50 and older are living with osteoporosis, and approximately 50% of women and 25% of men over age 50 will experience an osteoporosis-related fracture in their remaining lifetime. Recent research advancements have produced effective measures to improve and maintain bone health, including exercise, diet, screening tests, pharmacotherapies, and fall prevention strategies. These findings, however, have not been fully incorporated into the daily lives of adults, and many are unaware of the magnitude of bone-health problems. Thus, greater efforts must be made to effectively disseminate evidence-based research findings to improve bone health behaviors of the public. The Internet, with its increasing popularity, can be an effective tool in this endeavor. Despite a great deal of available online health resources, there has been a lack of research investigating effective methods to package and deliver these resources to yield positive public health outcomes. Expanding upon our prior findings and using an innovative approach combining two models of the social cognitive theory (SCT) and the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, Maintenance), in this proposal, we propose a large scale online study (N = 866) that will compare the long-term impact of two SCT-based online bone health interventions in adults age 50 and older targeting two large online communities. The two interventions are (1) an 8-week SCT-based Online Bone Health (TO-BoneHealth) program and (2) a 12-month TO-BoneHealth Plus program, including the TO-BoneHealth program followed by biweekly theory-based eNewsletters with follow-up of each individual's bone health behaviors ("booster" intervention) for 10 months. The interventions' impact will be assessed on the following the modified RE-AIM framework: (a) Effectiveness (knowledge, selected bone health behaviors, fall incidence, initiation of a discussion about bone health with a primary care provider, eHealth literacy); (b) Reach (number of participants the program reached); (c) Implementation (program usage); and (d) Maintenance (participants' bone health behavior maintenance). With the rapid growth of online communities, findings from this study will significantly contribute to current eHealth practice and research and serve as a dissemination model for other health promotion projects targeting online communities.
Background The standard care in patients with a painful osteoporotic vertebral compression fracture (VCF) is conservative therapy. Percutaneous vertebroplasty (PV), a minimally invasive technique, is a relatively new treatment option. Recent randomized controlled trials (RCT) provide conflicting results: two sham-controlled studies showed no benefit of PV while an unmasked but controlled RCT (VERTOS II) found effective pain relief at acceptable costs in patients with acute VCFs. A still ongoing masked RCT (VERTOS IV) focuses on acute VCFs defined as ≤ 6 weeks. VERTOS III focused on conservative treatment and found that half of patients still had disabling pain after 3 months or longer. These patients with sustained pain after 3 months may benefit from PV. Objective To compare pain relief after PV with a sham intervention in selected patients with a chronic osteoporotic VCF ( three months or longer) using the same strict inclusion criteria as in VERTOS II an IV. Secondary outcome measures are back pain related disability and quality of life. Methods The VERTOS V study is a prospective RCT with pain relief as primary endpoint. Inclusion criteria are a VCF of thoracic level 5 or lower with focal tenderness at fracture level, assessed by an internist on physical examination and a Visual Analogue Scale (VAS) score ≥ 5 for three months or longer, decreased bone density defined as T score ≤ -1 and age 50 years or older. 94 patients will be included, 47 in each arm. Crossovers are not allowed. Follow-up is at regular intervals during one year period with VAS score for pain as primary endpoint. Secondary endpoints are back pain related disability and quality of life measured with the Quality of Life Questionnaire of the European Foundation for Osteoporosis and physical function measured with the Roland Morris Disability questionnaire. Conclusion Vertos V is a methodologically sound masked randomised sham controlled trial of vertebroplasty in patients with sustained pain 3 months or longer after a vertebral compression fracture.
In this study, the investigators would like to analyze the bone mineral density (BMD) , bone turnover makers, and fracture prevention effects of daily teriparatide in Japanese patients under clinical practice. The participants are treated in the investigators hospital, who are under severe osteoporotic condition. Several determinants were reported to be related to subsequent BMD increase, such as baseline bone turnover markers (BTMs), low BMD at baseline, age, prior treatment, but comprehensive discussion is lacking. Specifically, there analyses were performed fragmentarily. The main objective of this study is to reveal the determinants of subsequent BMD increase and fracture preventing effect by teriparatide. Next, in Japan, as the baby boom generation retires, aging and depopulation occur rapidly. As a result, there is a lot of nursing home. But there are few reports concerning to the efficacy of teriparatide treatment in nursing home patients. The second objective is to reveal the efficacy of teriparatide for patients living nursing home, especially BMD changes, bone turnover makers change, and adverse events.
The primary objective of this study is to compare efficacy and safety of two formulations of teriparatide 20 mcg/day plus calcium and vitamin D in postmenopausal women with osteoporosis.
Postmenopausal Osteoporosis is characterized by a decrease in bone mass as well as a deterioration of the bone architecture resulting in an increased risk of fracture,which is directly related to the lack of estrogen and also associated with a variety of genetic and acquired factors. Previous studies have found that POP molecular regulation mechanism of kidney Yang deficiency syndrome may be associated with LTBP1 gene expression. This topic using RT-PCR and Western Blot detection POP of kidney Yang deficiency group and healthy group LTBP1 mRNA and proteion's expression level,validate LTBP1 relevance to POP the kidney Yang deficiency syndrome.To provide a scientific basis for clinical treatment.
Native American women may be considered high risk for osteoporosis due to lifestyle factors and incidence of type 2 diabetes. The objectives of this study are to: 1) determine the prevalence of osteopenia/osteoporosis in Native American female volunteers; 2) to evaluate their rate of bone loss; 3) to assess the relationship between lifestyle factors, inflammatory mediators, and select endocrine parameters on osteoporosis risk; and 4) determine the barriers to treatment. Participants will undergo a baseline, Year 1 and Year 2 follow-up osteoporosis risk assessment. Data will be analyzed using repeated measures ANOVA and logistical regression.
The objective of this study is to investigate the pharmacokinetics, safety, and tolerability of AK159 administered to healthy postmenopausal women.
Osteoporosis is a disease that leads to impaired skeletal strength and increased fracture risk. Among 200 million osteoporotic patients (Tarantino, Cannata et al. 2007) most are diagnosed only after a fracture. We expect with our aging population to see a significant increase in the prevalence of osteoporosis. It is estimated that over 75% of osteoporotic patients are not diagnosed and do not receive treatment for their condition. This research plan describes a study for clinical validation of the novel ultrasound device (Bindex®, Bone Index Finland Ltd.). In a preliminary study, the technique has been validated in a Finnish postmenopausal woman population of 285 healthy and 56 osteoporotic subjects (n = 341 in total). Significant and good correlation was observed between Density Index (DI) determined with Bindex and femoral neck bone mineral density determined with DXA (r = 0.65 - 0.70). In addition, with determination of 90% sensitivity and specificity thresholds, significant number (65-75%) of patients could be diagnosed without additional verification with DXA. For validation of the technique in US population, our study plan is presented for determination of diagnostic thresholds for osteoporosis. Taken together, DI with Bindex, lumbar spine and femoral bone BMD with DXA are obtained from 500 postmenopausal women and 140 men. The study will be carried out at the HealthEast Osteoporosis Care service in Woodbury, MN. 1. To investigate the capability of DI for prediction of proximal femur and lumbar spine BMD; 2. To develop national diagnostic thresholds for DI in prediction of osteoporosis status with a reference population (American-Caucasian) of 500 (if prevalence of osteoporosis is 20%) post-menopausal females (50-90 years); 3. To investigate ability of Density Index + FRAX with BMI in fracture risk prediction; 4. To investigate correlation between lumbar spine or proximal femur BMD and Density Index in 140 men at wide age range (20-90 years), 70 with osteoporosis and 70 with normal or low bone mass. Determine diagnostic thresholds for DI in men.
Objective: The study is to increasing osteoporosis awareness with fracture risk assessments and management as well as fall prevention among elderly in northern region of Taiwan. Method: Six community osteoporosis and fall prevention educational programme will be held at northern region of Taiwan. A questionnaires design including demographic variables , FRAX variables, nutritional variables and osteoporosis and fall knowledge variables as well.The pretest-posttest method was used to analyse the effect on education. Expected outcomes : (1)Fall prevention educational programme will hold in northern region of Taiwan at different communities in order to increasing osteoporosis awareness with fracture risk assessment tool, establishing fall knowledges among elderly and some fall prevention skills.(2)Elderly with 10-year probability of major osteoporotic fracture risk who more than 20% and 10-year probability of hip fracture risk who more than 3% will identify as high risk of osteoporosis. (3) To estimate number of cases who identified as high risk will recommend for BMD measurement.