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Brief Title † | PaTH Study: Parathyroid Hormone and Alendronate for Osteoporosis | ||||
Official Title † | Clinical Trial of Parathyroid Hormone (PTH) and Alendronate in Combination in the Treatment of Osteoporosis | ||||
Brief Summary | This 2-year study will test the effectiveness of combining parathyroid hormone (PTH) and alendronate for treating osteoporosis in postmenopausal women. Alendronate is a drug used to treat osteoporosis and primarily prevents bone loss, whereas PTH increases bone formation. We will treat the study participants either with PTH and alendronate, alendronate alone, or PTH alone. We will determine the effects of these treatments by looking for changes in bone mineral density in the hip and spine. |
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Detailed Description | The PaTH study is a 2-year, multicenter, double-blind, placebo-controlled trial to test the efficacy of combining hPTH (1-84) and alendronate for treating osteoporosis in postmenopausal women. 238 women were randomized between 55 and 85 years of age to receive either: (1) PTH for 1 year followed by alendronate for 1 year; (2) PTH and alendronate for 1 year followed by alendronate for 1 year; (3) alendronate for 2 years; or (4) PTH for 1 year followed by placebo for 1 year. The primary endpoints are changes in bone mineral density at several sites and changes in biochemical markers. In addition, we will assess specific biochemical markers of bone turnover (e.g., osteocalcin, deoxypridinoline, N-telopeptide, bone-specific alkaline phosphatase and bone sialoprotein) to determine if they can predict the skeletal response to combination therapy. We will also determine whether PTH positively affects ultrasound measurements in the calcaneus. |
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Study Phase | Phase II | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study | ||||
Primary Outcome Measure † | Changes in bone mineral density at several sites and changes in biochemical markers [ Time Frame: Year 2 ] [ Designated as safety issue: No ] | ||||
Secondary Outcome Measure † | Predictive value of specific biochemical markers of bone turnover [ Time Frame: Year 2 ] [ Designated as safety issue: No ] | ||||
Condition † | Osteoporosis | ||||
Intervention † | Drug: PTH Drug: Alendronate |
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MEDLINE PMIDs | 14500804, 16093464, 16449339, 17333451, 17164314 | ||||
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Recruitment Information Fields | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 238 | ||||
Start Date † | October 1999 | ||||
Completion Date | November 2007 | ||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Female | ||||
Ages | 55 Years to 85 Years | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Administrative Information Fields | |||||
NCT ID † | NCT00005005 | ||||
Organization ID | N01 AR92245 | ||||
Secondary IDs †† | NIAMS-045 | ||||
Study Sponsor † | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | ||||
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Information Provided By | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | ||||
Verification Date | September 2008 | ||||
First Received Date † | March 24, 2000 | ||||
Last Updated Date | September 19, 2008 |