Osteoporosis Clinical Trial
Official title:
Clinical Trial of Parathyroid Hormone (PTH) and Alendronate in Combination in the Treatment of 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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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