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Osteoporosis clinical trials

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NCT ID: NCT01934387 Completed - Osteoporosis Clinical Trials

Geriatric Health Exam Osteoporosis Screening

Start date: March 2013
Phase: N/A
Study type: Observational

BACKGROUND: The World Health Organization Fracture Risk Assessment Tool (WHO FRAX®) Taiwanese calculator is freely available on line to help osteoporosis management. However, its clinical utility for improving osteoporosis awareness and patient acceptance has not been validated in Taiwanese population. OBJECTIVES: This 11-month FRAX® based screening and referral program enrolling older adults participating in the geriatric health examinations (GHEs) at the National Taiwan University Hospital (NTUH) aiming at determine the patient acceptance of the tool and the program and to improve patient awareness in osteoporosis. The second aim is to look for the recommendations from the participating physicians to improve the FRAX® -based osteoporosis management model. METHODS: The NTUH GHE program is a two stage process to serve 3,000 older adults collecting annually from Mar. to Dec. Subjects will be enrolled to the current study at the stage 1 GHE visits after informed consent. Baseline questionnaires including the FRAX® tools will be distributed and expected to be returned at the stage 2 visits. Research assistants will calculate the 10-year predicted fracture risks for the participants during the waiting periods and present the numbers to the GHE physicians. High risks individuals will be referred to general geriatric clinic for further managements. All participants will be provided with osteoporosis and fracture educational material. Patient acceptance and awareness will be assessed. The study is to be started from Feb., to Oct., 2013 to enroll roughly 1,800 older adults assuming refusal rate about 40%. Qualitative interviews will be used to obtain recommendations from study geriatricians in Jul., 2013 to optimize the FRAX® based screening and management model.

NCT ID: NCT01932931 Completed - Osteoporosis Clinical Trials

Vitamin D, SSRIs and the Musculoskeletal System

Start date: October 1, 2013
Phase: N/A
Study type: Interventional

In recent years it has become evident that some types of antidepressants are associated both with an increased risk of falling and decreased bone mineral density. These factors predispose patients for serious fractures such as hip fractures with substantial morbidity and mortality. The specific mechanisms involved in this negative impact on bone and postural control have not been fully elucidated. It is well known that Vitamin D plays an important role for bone health as well as muscle function and thus indirectly postural control. Furthermore, vitamin D deficiency has been observed among depressed patients. To our knowledge no study has investigated the involvement of Vitamin D in relation to the increased risk of fractures associated with antidepressants. Therefore, this project will investigate the underlying mechanisms leading to skeletal impairment and musculoskeletal symptoms in patients receiving different types of antidepressants. Moreover, the effect of vitamin D supplementation will be investigated among patients taking these antidepressants. 150 subjects will participate in this study: 50 of which is diagnosed with depression and receive Citalopram (SSRIs); 50 depressed subjects receiving Mirtazapine(NaSRI); and 50 controls. Through randomisation half of the subjects in each group will receive daily Vitamin D supplementation for a period of one year. Through this period all 150 subjects will be followed through different measurements including bone density, muscle function and balance, nociception, quality of life and depression severity. It is expected that results from this study will provide increasing awareness and knowledge of the side effect profile of antidepressants on bone metabolism. This may prompt clinicians to screen patients at high risk of drug-induced osteopenia or osteoporosis and accordingly provide treatment, which may reduce the incidence of potentially avoidable fractures. Moreover, some types of antidepressants may show to produce a minimal or even no effect on bone turnover, and should be considered as first line treatment in the group of patients at risk of fractures.

NCT ID: NCT01930656 Completed - Osteoporosis Clinical Trials

Mobile Device to Help FRAX® Screening

Start date: March 2013
Phase: N/A
Study type: Observational

Background: The Taiwanese FRAX® (Fracture Risk Assessment Tool) calculator is available online for clinical use. Our Taiwanese Osteoporosis Clinical Treatment Guidelines suggests using the American high risk cut-points for considering treatment but also suggests deriving domestic cut-points from cost-effective approach. Establishing cost-effective domestic cut-points for policy suggestions coupled with mobile devices with wireless access would potentially increase the usage of FRAX® tool. Objectives: 1) Using literature review to establish cost-effectiveness FRAX® cut-points. 2) To assess the effectiveness of mobile devices assisted FRAX® tool based osteoporosis diagnostic and management model. 3) To provide FRAX® based reimbursement policy suggestions. Methods: 1) Investigators will use FRAX®, cost-effectiveness and other key words to search Pubmed and international osteoporosis guidelines to better understand the clinical applications of FRAX® in other countries. Investigators will also search epidemiological data for osteoporosis, facture, quality of life and cost to establish domestic cost-effeteness, and translational approach FRAX® cut-points. 2) Three targeting populations from National Taiwan University Hospital (NTUH) are selected for prospective study (Group A: geriatric health exam clinics with American cut-points, group B: orthopedic clinics with translational approach cut-points and group C: endocrine clinics with cost-effectiveness cut-points,). A mobile device with app application coupled with the FRAX® tool is used by a trained research assistant during clinic waiting periods to screen and enroll high risk (75 from each clinic) adults with informed consents. Participants are referred to geriatric clinics for systemic osteoporosis diagnoses and managements. Percentage of participants that meet the current NHI medication reimbursement regulation and percentage of self-pay medications are calculated. Analysis is stratified by age and gender. 3) The impacts of 3 different cut-points on increment NHI reimbursement are estimated. An osteoporosis expert group meeting is to be held for FRAX® based osteoporosis medication reimbursement modifications to the NHI and the Department of Health. Expected Outcomes: 1) To establish the mobile device assisted FRAX® based osteoporosis screening and management model. 2) Base on the study results and expert consensus, investigators will provide policy suggestions of FRAX® based reimbursement modifications.

NCT ID: NCT01928134 Completed - Healthy Clinical Trials

The Efficacy of Vitamin K2 n Human Osteoporosis, Blood-vessel Calcification and Sclerosis

Start date: April 2011
Phase: N/A
Study type: Interventional

This study used the generally recognized as safe (GRAS) grade of Bacillus subtilis natto to produce Vitamin K2, Menaquinone-7(MK-7), via fermentation, for functional evaluation. There are four major objectives for this study: (1) bioavailability of calcium; (2) evaluation of bone density improvement; (3) evaluation of blood-vessel calcification and sclerosis improvement; (4) safety evaluation.

NCT ID: NCT01910142 Completed - Osteoporosis Clinical Trials

Effect of Nutrition on Bone Metabolism as Assessed by 41Ca

Start date: November 2008
Phase: N/A
Study type: Interventional

The present study aims to develop a technique based on a single dose of a calcium isotope, which enables to determine the effect of a nutritional intervention on bone calcium metabolism. For this purpose nutritional interventions with calcium, vitamin D and vitamin K will be applied in postmenopausal women. Treatment effects will be determined by the urinary excretion of the calcium isotope and related to classical bone markers.

NCT ID: NCT01907269 Completed - Osteoporosis Clinical Trials

A Direct-to-patient Intervention to Increase Rates of Osteoporosis Care

APROPOS
Start date: August 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to conduct a randomized trial of a tailored intervention designed to provide personalized feedback regarding patients' risk of subsequent fractures, customized information regarding osteoporosis care, and messaging to activate patients to become more engaged in improving osteoporosis treatment and doctor-patient communication. This novel content will use "story-telling" delivered via the Internet and digital video discs (DVDs). The content will be uniquely tailored to each person based on barriers to care, age and race/ethnicity. We will conduct a controlled, cluster-randomized trial of this intervention to determine differences in post-intervention rates of osteoporosis care between two randomization arms. We hypothesize that participants randomized to the intervention arm, compared to those randomized to a control arm, will receive more osteoporosis care at 6 months post-intervention, as evidenced by higher rates of: (H1) Prescription osteoporosis therapies, (H2) Non-prescription therapy with calcium and vitamin D, and (H3) Bone mineral density (BMD) testing.

NCT ID: NCT01904110 Completed - Osteoporosis Clinical Trials

To Evaluate the Efficacy and the Safety of Monthly Versus Weekly Oral Risedronate With Vitamin D in Compliance, Improvement of Vitamin D and BMD in Korean Postmenopausal Osteoporotic Women

Start date: December 2012
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the Efficacy and the Safety of Monthly(RisenexM group) versus Weekly Oral risedronate(Risenexsplus group) in Korean postmenopausal osteoporotic women(Phase IV)

NCT ID: NCT01900860 Completed - Clinical trials for Age-Related Osteoporosis

Dose-dependent Effects of Vitamin D on Bone Health

Start date: August 2013
Phase: N/A
Study type: Interventional

We propose to conduct a randomized double blind trial of three doses of vitamin D, 400, 4000, and 10,000 International Units (IU) per day, to assess the effect on bone density and architecture as assessed by high resolution peripheral quantitative tomography (HR-pQCT) measurements at the radius and distal tibia, and standard Dual X-ray absorptiometry (DXA). Other measures of bone and calcium metabolism will be assessed. The trial will last as long as three years. Approximately 300 healthy men and women, aged 50-70 years of age, will be recruited, and randomly assigned to one of the three doses of vitamin D. Other outcome variables assessed include quality of life, depression, muscle strength and balance.

NCT ID: NCT01892098 Completed - Osteoporosis Clinical Trials

Zinc and Bone Turnover Study in Adolescent Females

Start date: February 2007
Phase: N/A
Study type: Interventional

The purpose of the study is to determine the effects of zinc supplementation on bone growth over four weeks. Participants will agree to attend two visits to our laboratory and at each will complete blood and urine samples, questionnaires related to diet and physical activity and will receive a bone scan at the first appointment.

NCT ID: NCT01887392 Completed - Osteoporosis Clinical Trials

Gaining Optimal Osteoporosis Assessments in Long-Term Care (GOAL)

GOAL
Start date: June 2013
Phase: N/A
Study type: Interventional

The aim of this study is to disseminate the 2010 Osteoporosis Canada clinical practice guidelines, using a multi-faceted Knowledge Translation (KT) model, as KT aims to close the gap between knowledge generated from research and practice. The investigators' primary objective is to evaluate if this intervention can increase the percent of long-term care (LTC) residents receiving appropriate treatment for osteoporosis (i.e. treatment is considered appropriate for an individual over age 50 who has had a diagnosis of osteoporosis or a fragility fracture of the hip or vertebrae and those who have had more than one fragility fracture and is therefore considered high-risk). A secondary objective is to examine whether the intervention increases the percent of all LTC residents receiving Vitamin D equivalent to ≥800 IU/day.