To determine how prior therapy with alendronate or risedronate in postmenopausal women with osteoporosis influences the clinical effectiveness of teriparatide; The primary objective of the study is to compare the teriparatide (human, recombinant PTH\[1-34\])-associated change from baseline in a marker of bone formation, N-terminal propeptide of type I collagen (P1NP), between subjects previously treated with risedronate and those previously treated with alendronate.
All subjects will be treated with teriparatide (human, recombinant PTH\[1-34\])(human, recombinant PTH\[1-34\]), 20 microgram subcutaneously daily for 12 months. Subjects will consist of 290 postmenopausal women previously treated with either risedronate or alendronate for at least 24 months. An approximately equal number of subjects will have been previously treated with risedronate and alendronate, and the subjects will be balanced with regard to duration of previous treatment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
290
sanofi-aventis, US
Bridgewater, New Jersey, United States
sanofi-aventis, Australia
Cove, New South Wales, Australia
sanofi-aventis, Belgium
Diegem, Belgium
sanofi-aventis, Canada
Laval, Quebec, Canada
Compare the PTH-associated change from baseline at Month 3 of procollagen peptide P1NP, in subjects previously treated with Risedronate or Alendronate
Time frame: at Month 3
Compare changes from baseline for subjects previously treated with Risedronate or Alendronate for: P1NP & other biomarkers including bone-specific alkaline phosphatase, osteocalcin, serum CTX, urine NTX
Time frame: at 0.5, 1, 2, 3, 4, 5, 6, & 12 months of treatment
Compare changes from baseline for subjects previously treated with Risedronate or Alendronate for: Lumbar spine & hip BMD measured by DXA
Time frame: after 6 & 12 months of treatment
Compare changes from baseline for subjects previously treated with Risedronate or Alendronate for: Bone quality parameters captured by central quantitative computed tomography (QCT)
Time frame: after 12 months of treatment
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sanofi-aventis, France
Paris, France
sanofi-aventis, Netherlands
Gouda, Netherlands
sanofi-aventi, UK
Guildford, Surrey, United Kingdom