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Trial NCT00000427

Resource URI: http://static.linkedct.org/resource/trials/NCT00000427
PropertyValue
linkedct:brief_title Effects of Parathyroid Hormone in Men With Osteoporosis
linkedct:condition <http://static.linkedct.org/resource/condition/9389>
linkedct:criteria Inclusion Criteria: - Bone density of the spine or femoral neck two standard deviations below the mean of young adult men - Normal renal and liver function tests, normal serum testosterone level, normal vitamin D and PTH levels Exclusion Criteria: - Significant cardiac, renal, hepatic, or malignant disease. - Disorders (e.g., Paget's disease, hyperthyroidism, hyperparathyroidism) or drugs (e.g., steroids, anticonvulsants, lithium, bisphosphonates, calcitonin, fluoride) known to affect bone metabolism - Active peptic ulcer disease or severe reflux
linkedct:description Osteoporosis causes bones to weaken and break more easily. Alendronate is used to treat or prevent osteoporosis. PTH is a protein hormone that increases the calcium and phosphorus release from bone, leading to formation of new bone. This study will examine the changes in bone density measured at multiple places in the skeleton and changes in chemicals in the body that indicate bone breakdown and bone formation. The study will indicate whether some breakdown of bone is required for PTH to have an overall bone-building effect in men. Participants will be randomly assigned to receive PTH alone by daily injection under the skin, alendronate alone taken by mouth, or both PTH and alendronate. The study will last 2.5 years. All participants will receive some form of treatment for osteoporosis. Blood, urine, and bone density tests will be performed at 6-month intervals. During the first 6 months, participants will come in for additional study visits. Participants who complete the initial 2.5 years of their assigned treatment will be eligible for a 12 month extension to monitor bone density and bone turnover after PTH is stopped. Participants who were receiving alendronate will continue taking alendronate. The goal of this extension is to determine what happens to bone density and turnover after PTH is stopped and whether alendronate is needed to prevent loss of PTH-induced bone gain. Participants who complete the 12 month extension while on their assigned treatment will be eligible for a second 12 month extension in which all participants receive PTH therapy. Participants who have been receiving alendronate continue taking alendronate. The goal of the second extension is to determine if responsiveness to PTH is enhanced by a 12 month suspension of PTH treatment.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Male
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 85 Years
linkedct:eligibility_minimum_age 46 Years
linkedct:end_date October 2005
linkedct:enrollment 81 (xsd:int)
linkedct:firstreceived_date January 18, 2000
linkedct:id NCT00000427
rdfs:label Trial NCT00000427
linkedct:lastchanged_date February 29, 2008
linkedct:lead_sponsor_agency National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
linkedct:location <http://static.linkedct.org/resource/location/147472>
linkedct:nct_id NCT00000427
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Anabolic Actions of Parathyroid Hormone in Osteoporotic Men
linkedct:org_study_id P50 AR44855
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/28364>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2920>
foaf:page <http://clinicaltrials.gov/show/NCT00000427>
linkedct:phase Phase 3
linkedct:primary_completion_date October 2005
linkedct:reference <http://static.linkedct.org/resource/reference/19296>
linkedct:reference <http://static.linkedct.org/resource/reference/46937>
linkedct:results_reference <http://static.linkedct.org/resource/results_reference/5973>
linkedct:secondary_id NIAMS-015
linkedct:source National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
linkedct:start_date September 1999
linkedct:study_design Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
linkedct:study_type Interventional
linkedct:summary Alendronate is a drug that blocks or reduces bone loss, while parathyroid hormone (PTH) stimulates the formation of new bone. The purpose of this study is to compare the bone-building effects of PTH alone, alendronate alone, and both PTH and alendronate in men with osteoporosis over a two-and-a-half year period.
rdf:type linkedct:trials
linkedct:verification_date February 2008