PaTH Study: Parathyroid Hormone and Alendronate for Osteoporosis
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|ClinicalTrials.gov Identifier: NCT00005005|
Recruitment Status : Completed
First Posted : March 27, 2000
Last Update Posted : February 5, 2013
|Condition or disease||Intervention/treatment||Phase|
|Osteoporosis||Drug: PTH Drug: Alendronate||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||238 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Clinical Trial of Parathyroid Hormone (PTH) and Alendronate in Combination in the Treatment of Osteoporosis|
|Study Start Date :||October 1999|
|Actual Primary Completion Date :||November 2007|
|Actual Study Completion Date :||November 2007|
Participants will receive PTH for 1 year followed by alendronate for 1 year.
|Drug: PTH Drug: Alendronate|
Participants will receive PTH and alendronate for 1 year followed by alendronate for 1 year.
|Drug: PTH Drug: Alendronate|
Participants will receive alendronate for 2 years.
Active Comparator: 4
Participants will receive PTH for 1 year followed by placebo for 1 year.
- Changes in bone mineral density at several sites and changes in biochemical markers [ Time Frame: Year 2 ]
- Predictive value of specific biochemical markers of bone turnover [ Time Frame: Year 2 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005005
|United States, Maine|
|Maine Center for Osteoporosis|
|Bangor, Maine, United States, 04401|
|United States, Minnesota|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55415|
|United States, New York|
|New York, New York, United States, 10032|
|United States, Pennsylvania|
|University of Pittsburgh Medical Center|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Dennis Black, PhD||University of California, San Francisco|