Treatment of adynamic bone disorder with parathyroid hormone in patients with chronic kidney disease

Adynamic bone disorder

The difference between the two groups (treated versus controls) in changes in BSAP after 18 months

Changes between baseline and 18 months as well as differences between treated and untreated in: Number of patients who no longer have adynamic bone disorder based on a BSAP >21 µg/l, Changes between baseline and 18 months as well as differences between treated and untreated in: BMD at the lumbar spine, antebrachium, femoral neck and total hip, Changes between baseline and 18 months as well as differences between treated and untreated in: Incidence of fragility fractures and vertebral fractures assessed using vertebral fracture assessment (VFA) or x-ray of columna, Changes between baseline and 12 months as well as differences between treated and untreated in: Bone microarchitecture, volumetric BMD, bone geometry and bone strength assessed using high-resolution peripheral quantitative computed tomography (HR-pQCT), Changes between baseline and 12 months as well as differences between treated and untreated in: Regional bone formation using 18F-NAF PET/CT, Changes between baseline and 18 months as well as differences between treated and untreated in: P-parathyroid hormone (intact, whole and nonoxidated-PTH), p-ionised calcium, p-phosphate, p-magnesium, p-FGF-23 and p-sclerostin, Changes between baseline and 18 months as well as differences between treated and untreated in: Bone microstructure by micro-computer tomography (µCT) of the bone biopsy, Changes between baseline and 12 months as well as differences between treated and untreated in: Static and dynamic bone histomorphometry classified by the TMV classification assessed by bone biopsy, Changes between baseline and 18 months as well as differences between treated and untreated in: Detailed histology of underlying cellular mechanisms using a combination of immunostainings and advanced in situ hybridizations on the bone biopsy, Changes between baseline and 18 months as well as differences between treated and untreated in: Bone turnover markers i.e. intact PINP, TRAP5b, osteocalcin, RANKL and OPG, Changes between baseline and 18 months as well as differences between treated and untreated in: 24-hour blood pressure and pulse wave measurements including velocity, Changes between baseline and 18 months as well as differences between treated and untreated in: T50, NT-proBNP as well as other cardiovascular biomarkers, Changes between baseline and 18 months as well as differences between treated and untreated in: The incidence of adverse reactions

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