The primary objective of this trial is to show that PTH(1-84) is superior to strontium ranelate in bone formation measured as changes in bone formation markers over a treatment period of 24 weeks in postmenopausal women with primary osteoporosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
82
Once daily subcutaneous injection in the abdomen by self administration
The daily dose of 2 g (one sachet) strontium ranelate was to be mixed in a glass of water and taken immediately after mixing at bedtime at least 2 hours before or after intake of calcium, any food or drinks, other than water
Nycomed
Roskilde, Denmark
Percentage Change in the Bone Formation Marker N-terminal Propeptides of Human Procollagen Type I (P1NP) From Baseline to End of Trial
P1NP is a bone formation marker that is derived from the amino-terminal propeptides of type I collagen and is considered a quantitative measure of newly formed type I collagen. Bone marker measurements were done by blood analysis.
Time frame: Baseline and 24 weeks of treatment
Percentage Change in the Bone Formation Marker Bone Specific Alkaline Phosphatase (BSAP) From Baseline to End of Trial
BSAP is a marker of bone formation that reflects the cellular activity of osteoblasts. Bone marker measurements were done by blood analysis.
Time frame: Baseline and 24 weeks of treatment
Percentage Change in the Bone Resorption Marker C-Telopeptide Cross-links (CTX) From Baseline to End of Trial
CTX is a marker of bone resorption, which is a degradation product of bone collagen. Bone marker measurements were done by blood analysis.
Time frame: Baseline and 24 weeks of treatment
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