PaTH Study: Parathyroid Hormone and Alendronate for Osteoporosis
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Clinical Trial of Parathyroid Hormone (PTH) and Alendronate in Combination in the Treatment of Osteoporosis|
- Changes in bone mineral density at several sites and changes in biochemical markers [ Time Frame: Year 2 ] [ Designated as safety issue: No ]
- Predictive value of specific biochemical markers of bone turnover [ Time Frame: Year 2 ] [ Designated as safety issue: No ]
|Study Start Date:||October 1999|
|Study Completion Date:||November 2007|
|Primary Completion Date:||November 2007 (Final data collection date for primary outcome measure)|
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.
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.
|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|