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Trial NCT00000400

Resource URI: http://static.linkedct.org/resource/trials/NCT00000400
PropertyValue
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/33411>
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/58965>
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/58969>
linkedct:brief_title Alendronate and/or Parathyroid Hormone for Osteoporosis
linkedct:condition <http://static.linkedct.org/resource/condition/9389>
linkedct:criteria Inclusion Criteria: - Lumbar spine or hip BMD T-score less than or equal to minus 2.0 - Postmenopausal at least 5 years - Fully ambulatory - Able to give informed consent Exclusion Criteria: - No concurrent illnesses that cause bone loss - No recent drug treatment for osteoporosis - No recent fracture
linkedct:description This is a randomized, prospective, open-label study in which osteoporotic postmenopausal women self-administer synthetic hPTH-(1-34), alendronate, or both, every day for 2.5 years. Participants initially come to Massachusetts General Hospital once a month, and subsequently once every 3-6 months, for measurements of serum and urine indices of bone formation and resorption, serum and urine toxicity tests, and DXA/QCT measurements of bone mass. One-third of the participants take hPTH-(1-34) daily, one-third take alendronate once daily, and one-third take both daily (Phase A, months 0-30). Participants who complete Phase A are eligible for a 12 month extension study (Phase B, months 30-42), during which any alendronate treatment is continued without change and any hPTH 1-34 treatment is stopped. Participants who complete Phase B are eligible for a second 12 month extension study (Phase C, months 42-54), during which any alendronate treatment is continued without change and every participant takes hPTH 1-34. During Phases B and C, these participants come to Massachusetts General Hospital once every 6 months for measurements of serum and urine indices of bone formation and resorption, serum and urine toxicity tests, and DXA/QCT measurements of bone mass.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 85 Years
linkedct:eligibility_minimum_age 45 Years
linkedct:end_date June 2006
linkedct:enrollment 176 (xsd:int)
linkedct:firstreceived_date November 3, 1999
linkedct:has_dmc Yes
linkedct:id NCT00000400
linkedct:intervention <http://static.linkedct.org/resource/intervention/27110>
linkedct:intervention <http://static.linkedct.org/resource/intervention/29428>
rdfs:label Trial NCT00000400
linkedct:lastchanged_date November 10, 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 NCT00000400
linkedct:number_of_arms 3 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Bone Formation-Resorption Coupling and Osteoporosis
linkedct:org_study_id P50 AR44855 NIAMS-023
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/50867>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2920>
foaf:page <http://clinicaltrials.gov/show/NCT00000400>
linkedct:phase Phase 2
linkedct:primary_completion_date April 2006
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/72730>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/15701>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/15704>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/15728>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/15842>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/15843>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/15845>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/15866>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/52974>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/52975>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/53050>
linkedct:source National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
linkedct:start_date August 1999
linkedct:study_design Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
linkedct:study_type Interventional
linkedct:summary This study looks at the effects of two medications, alendronate and parathyroid hormone, on bone mass and on bone formation and bone breakdown in women with osteoporosis. We will randomly select postmenopausal women who have osteoporosis to receive laboratory-produced human parathyroid hormone (hPTH), or alendronate, or both for 2.5 years. Study participants will return to the study center periodically to have their bone mass measured and to give blood and urine samples for tests of bone formation and breakdown and for other laboratory tests. Those who complete the study are eligible for one or two 12 month extension studies.
rdf:type linkedct:trials
linkedct:verification_date November 2008