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Bone Diseases clinical trials

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NCT ID: NCT00157690 Completed - Cystic Fibrosis Clinical Trials

Study of Alendronate to Prevent and Treat Osteoporosis in Cystic Fibrosis Patients

Start date: December 2003
Phase: Phase 4
Study type: Interventional

The primary objective of this study is to determine efficacy of 70 mg alendronate once weekly compared to placebo. This will be measured by percent changes in lumbar spine(LS) bone mineral density(BMD) in adult cystic fibrosis(CF)patients after one year of treatment. The investigators hypothesize that in adult CF patients with osteopenia or osteoporosis, alendronate 70 mg once weekly will produce a mean increase from baseline in lumbar spine BMD that is greater than that observed with placebo at 12 months.

NCT ID: NCT00155961 Completed - Metabolic Syndrome Clinical Trials

Odense Androgen Study in the Elderly

Start date: March 2002
Phase: Phase 1
Study type: Observational

Introduction Male ageing is associated with sarcopenia, frailty, osteopenia, obesity, the metabolic syndrome and cardiovascular disease. To what extent the androgens affect these signs of ageing is still largely undetermined. A few studies have shown divergent results concerning the relation between ageing and serum levels of testosterone. It still remains to be shown whether there is a pure age-related decline in serum testosterone or whether other factors such as obesity, chronic illness or medication are responsible for the lower serum testosterone found in elderly men when compared with young men. To investigate these issues a cohort of 600 men aged 60 to 75 years is examined. Objective The aim of the study is to investigate the relation of testosterone (T) to body composition (BC) and physical performance (PP). Measures for BC are muscle mass (MM), bone mineral density (BMD) and fat mass (FM). Parameters for PP are maximum voluntary force (MVF), maximum oxygen uptake (VO2max) and muscle power (P). We hypothesize that T is positively associated with MM, BMD and all PP parameters, but negatively associated with FM. We will furthermore examine whether life style, medication, chronic disease, hormones and binding proteins exert their actions on BC and PP solely through or independently of T. The levels of s-total and free T in this cohort will be compared with the s-total and free T levels from a cohort of young men aged 20 to 30 years. Furthermore the associations found between T and BC and PP in the two cohorts will be compared to investigate whether T plays the same role in the two groups.

NCT ID: NCT00150163 Active, not recruiting - Bone Diseases Clinical Trials

Odense Androgen Study: Study of Androgens, Body Composition, and Muscle Function in Danish Men

Start date: March 2002
Phase: N/A
Study type: Observational

Objective: - To define a reference-population of healthy young men (20-29 years old). - To establish reference-intervals for: 1. Total, bioavailable and free serum androgens (testosterone, dihydrotestosterone, androstenedione) and serum estrogens (estradiol, estrone). 2. Total and free IGF-1. - To study the influence of physical activity, alcohol intake, tobacco and abuse of anabolic steroids on serum levels of androgens. - To identify the androgens (or estrogens) that primarily reflect the following parameters: 1. Muscle mass, muscle strength, muscle power, oxygen uptake, and hematocrit. 2. Bone mineral density and bone metabolism. 3. Total and visceral fat mass. 4. Lipid- and glucose metabolism and glucocorticoid metabolism. 5. Sexual function and quality of life. - To study the modifying effect of birth weight, the AR gene CAG-repeat polymorphism, and the level of IGF-1 on associations between serum androgens and the measures above: Ethics, design and schedule: The local ethic review board approved a population-based, cross-sectional study planned for the inclusion of 800 Caucasian men, 20 to 29 year old, living in the County of Funen. The only exclusion criteria were opioid drug addiction, cancer, and severe chronic disease. A basic questionnaire was mailed to 3000 men, randomly drawn from the Danish Central Personal Registry. Adequately answered questionnaires were returned from 2,199 men, who subsequently received an invitation to participate. Informed consent was obtained from 783 men. The examinations started in March 2002 and terminated in May 2003. Within subject variation was determined for all study parameters in 20 men. The men included matched the men answering the questionnaire on all questionnaire items and demographics. All analyses have been performed, except for the additional serum sex hormone assays, IGF-1 assays and AR gene analyses. A sequential rule-out from the reference population was performed on the following criteria: 1. testicular pathology: bilateral cryptorchidism, varicocele, testes volumina < 10 ml (each), history of spermatic cord torsion. 2. severe chronic disease. 3. regular medication or abuse of anabolic steroids. 4. body mass index < 19 kg/m2. 5. safety serum parameters: luteinizing hormone (LH) <1.0 U/L or >8.4 U/l, alanine-amino-transferase (ALAT) >70 U/l and thyrotropin (TSH) >6.0 mU/l.

NCT ID: NCT00147823 Completed - Bone Diseases Clinical Trials

Comparing Synthetic Bone Alone Versus Synthetic Bone With Bone Marrow in Bone Lesions

Start date: December 2004
Phase: N/A
Study type: Interventional

This is a prospective randomized study comparing Vitoss alone versus Vitoss with bone marrow aspirate in benign bone lesions.

NCT ID: NCT00103740 Completed - Clinical trials for Paget's Disease of Bone

Safety and Efficacy Trial With Zoledronic Acid for the Treatment of Paget's Disease of Bone, Including an Extended Observation Period

Start date: April 2002
Phase: Phase 3
Study type: Interventional

The primary objective of this core study was to show non-inferiority of zoledronic acid to risedronate, with respect to the proportion of patients who achieved therapeutic response. The extended observation period included participants of the core study who responded to treatment.

NCT ID: NCT00099203 Terminated - Pain Clinical Trials

A Study to Assess the Efficacy of Intravenous Bondronat (Ibandronate) in Patients With Malignant and Painful Bone Disease

Start date: July 2005
Phase: Phase 3
Study type: Interventional

This 2 arm study will compare the efficacy of intravenous Bondronat with that of zoledronic acid in patients with malignant bone disease experiencing moderate to severe pain. Patients will be randomized to receive either Bondronat (6mg iv on days 1, 2 and 3 and then every 3-4 weeks) or zoledronic acid (4mg iv on day 1 and then every 3-4 weeks). The anticipated time of study treatment is 6-12 months, and the target sample size is 100-500 individuals.

NCT ID: NCT00099177 Terminated - Pain Clinical Trials

A Study to Assess the Efficacy of Intravenous/Oral Bondronat (Ibandronate) in Patients With Metastatic Bone Disease Experiencing Moderate to Severe Pain

Start date: August 2005
Phase: Phase 3
Study type: Interventional

This 2 arm study will compare the efficacy of a regimen of intravenous (iv) and oral Bondronat with that of zoledronic acid in patients with malignant bone disease experiencing moderate to severe pain. Patients will be randomized to receive either Bondronat (6mg iv on days 1, 2 and 3 followed by Bondronat 5Omg po daily from day 22 to week 24) or zoledronic acid (4mg iv on day 1, and then every 3-4 weeks). The anticipated time of study treatment is 6-12 months, and the target sample size is 100-500 individuals.

NCT ID: NCT00076830 Completed - Clinical trials for Osteogenesis Imperfecta

Evaluation and Treatment of Patients With Connective Tissue Disease

Start date: May 18, 2004
Phase:
Study type: Observational

This study offers evaluation and treatment of patients with a suspected connective tissue disorder. The protocol is not designed to test new treatments; rather, patients receive standard care. The study is designed to: 1) allow NICHD's staff to learn more about connective tissue disorders, 2) train physicians in the evaluation and treatment of these disorders; and 3) establish a pool of patients who may be eligible for other NICHD protocols for connective tissue disorders. (Participants in this protocol will not be required to join another study; the decision will be voluntary.) Patients of all ages with a suspected connective tissue disorder and their unaffected family members may be eligible for this study. Participants undergo diagnostic procedures that may include a medical history, physical examination, X-ray studies, eye examinations, and blood drawing, as well as other specialized tests, when needed. Additional tests may include: - Blood test for DNA genetic analysis - Skin biopsy: Removal of a small piece of tissue for microscopic examination. The area of skin selected for the biopsy is numbed and a small circle of skin, usually from the upper arm, is removed with a surgical cookie cutter-like instrument. - Magnetic resonance imaging (MRI): This test uses a strong magnetic field and radio waves to show structural and chemical changes in tissues. The patient lies on a table that slides into a narrow cylinder containing a magnetic field. Ear plugs are worn to muffle loud knocking and thumping sounds that occur with electrical switching of the magnetic fields. - Computed tomography (CT) scans: This test allows the doctor to view the organs inside the body in small sections. The patient lies in a doughnut-like machine. Scanning can be done from different angles, allowing a three dimensional picture of the part of the body being studied. It may be done with or without injection of a contrast material. - Referral to appropriate sub-specialists when potential complications are found.

NCT ID: NCT00070681 Completed - Clinical trials for Cardiovascular Diseases

Outcomes of Sleep Disorders in Older Men

Start date: September 2003
Phase: Phase 3
Study type: Observational

To determine the effects of sleep disorders on cardiovascular function and disease in older men.

NCT ID: NCT00067834 Completed - Osteopenia Clinical Trials

Electromagnetic Treatment For Bone Loss After Forearm Fracture

Start date: November 2003
Phase: Phase 1/Phase 2
Study type: Interventional

This study will determine the usefulness of pulsing electromagnetic field (PEMF) technology to reverse or reduce the bone loss (osteopenia) that occurs in the forearm after fracture or surgery.