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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.
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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.
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125 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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