Increased bone formation in the absence of accelerated resorption is resulting in a marked anabolic response to teriparatide (TPTD) during the early phase after treatment initiation. Months later, due to coupling mechanism, the sustained increase of bone formation and ongoing anabolic effects are accompanied by significantly increased bone resorption as well. Antiresorptives influence the balance of bone formation and resorption. Therefore the investigators aim is to investigate the effects of the addition of antiresorptives to the second half of TPTD cycle when resorption is already also markedly elevated.
We prospectively randomize 125 postmenopausal women after 9 months of TPTD treatment into three different open-label groups for another 9 months: either alendronate (ALN, 70 mg/week), raloxifene (RAL, 60 mg/day) or no medication (TPTD mono) on top of ongoing TPTD treatment. All subjects receive daily supplementation of 1000mg calcium and 800 IU vitamin D. Serum level of intact amino terminal propeptide of type I procollagen (PINP) and type 1 collagen cross-linked C-telopeptide (CTX) as well as DXA measurement at the spine, total hip and femoral neck BMD are evaluated at TPTD treatment initiation, at baseline of randomization to antiresorptive therapy as well as at 3 and 9 months during the combination treatment.Volumetric BMD values will be also determined.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
125
teriparatide 20 ug/day, sc.
teriparatide 20 ug/day sc. raloxifene 60mg oral daily
teriparatide 20 ug/day sc. alendronate 70mg oral weekly
Medical University of Vienna
Vienna, State of Vienna, Austria
Differences in changes of areal lumbar spine BMD between the three treatment groups
Primary objective To investigate the changes in lumbar spine BMD of patients among the three treatment groups
Time frame: Evaluation after 9, 12 and 18 months of TPTD
Differences in changes of BMDs and markers of bone turnover among the three treatment groups after 18 months TPTD treatment
Secondary objectives * Differences in change of biochemical markers of bone turnover (serum CTX and serum PINP) between treatment groups * Differences in change of the additional DXA results in the hip scan (neck, upper neck, nape, Wards, Troch, shaft, total hip \[g/cm²\]) of patients between treatment groups * To investigate the volumetric changes of vertebral and hip BMD by quantitative computertomography of patients between treatment groups * To investigate safety and tolerability of the treatments
Time frame: Evaluation after 9, 12 and 18 months of TPTD treatment
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