| Outcome Measures: |
Primary: Changes in bone specific alkaline phosphatase (BSAP), The difference between treated and controls in changes from baseline to 18 months in bone specific alkaline phosphatase, Baseline and 18 months | Secondary: Number of patients who no longer has adynamic bone disorder based on a BSAP >21 µg/l, Changes between baseline and 18 months as well as differences between treated and controls., Baseline and 18 months. It is also measured through study completion, an average of 30 months|BMD at the lumbar spine, antebrachium, femoral neck and total hip, Changes between baseline and 18 months as well as differences between treated and controls, Baseline and 18 months. The scan is also performed at 30 months|Incidence of fragility fractures and vertebral fractures assessed using x-ray of columna or vertebral fracture assessment (VFA), Changes between baseline and 18 months as well as differences between treated and controls, Baseline and 18 months. The scan is also performed at 30 months|Bone microarchitecture assessed using high-resolution peripheral quantitative computed tomography (HR-pQCT), Changes between baseline and 12 months as well as differences between treated and controls. The HR-pQCT scan is a voluntary procedure., Baseline and 12 months|Volumetric BMD assessed using high-resolution peripheral quantitative computed tomography (HR-pQCT), Changes between baseline and 12 months as well as differences between treated and controls. The HR-pQCT scan is a voluntary procedure., Baseline and 12 months|Bone geometry assessed using high-resolution peripheral quantitative computed tomography (HR-pQCT), Changes between baseline and 12 months as well as differences between treated and controls. The HR-pQCT scan is a voluntary procedure., Baseline and 12 months|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 controls. The HR-pQCT scan is a voluntary procedure., Baseline and 12 months|Regional bone formation using 18F-Sodium Fluoride Positron Emission Tomography/Computed Tomography (18F-NAF PET/CT), Changes between baseline and 12 months as well as differences between treated and controls. The 18F-NAF PET/CT is a voluntary procedure., Baseline and 12 months|Changes in p-PTH, Changes between baseline and 18 months as well as differences between treated and controls., Baseline and 18 months. Some of them are also measured during follow up.|Changes in p-phosphate, Changes between baseline and 18 months as well as differences between treated and controls., Baseline and 18 months. Some of them are also measured during follow up.|Changes in p-magnesium, Changes between baseline and 18 months as well as differences between treated and controls., Baseline and 18 months. Some of them are also measured during follow up.|Changes in calcium, P-ionised calcium. Changes between baseline and 18 months as well as differences between treated and controls., Baseline and 18 months. Some of them are also measured during follow up.|Bone histomorphometry, Static and dynamic bone histomorphometry classified by the bone Turnover Mineralization Volume (TMV) classification assessed by bone biopsy. Performed after 12 months. This is a voluntary procedure., 12 months|Changes in Intact Procollagen type 1 N-terminal Propeptide (P1NP), Changes between baseline and 18 months as well as differences between treated and controls., Baseline and 18 months. They are also measured during follow up|Changes in total P1NP, Changes between baseline and 18 months as well as differences between treated and controls., Baseline and 18 months. They are also measured during follow up|Changes in Tartrate-Resistant Acid Phosphatase 5b (TRAP5b), Changes between baseline and 18 months as well as differences between treated and controls., Baseline and 18 months. They are also measured during follow up|Changes in sclerostin, Changes between baseline and 18 months as well as differences between treated and controls., Baseline and 18 months. They are also measured during follow up|Changes in Receptor Activator of Nuclear factor Kappa-B Ligand (RANKL), Changes between baseline and 18 months as well as differences between treated and controls., Baseline and 18 months. They are also measured during follow up|Changes in Osteoprotegerin (OPG), Changes between baseline and 18 months as well as differences between treated and controls., Baseline and 18 months. They are also measured during follow up|Changes in Fibroblast Growth Factor 23 (FGF-23), Changes between baseline and 18 months as well as differences between treated and controls., Baseline and 18 months. They are also measured during follow up|24-hour blood pressure, Changes between baseline and 18 months as well as differences between treated and controls. These are voluntary procedures., Baseline and 18 months|Pulse wave measurements including velocity, Changes between baseline and 18 months as well as differences between treated and controls. These are voluntary procedures., Baseline and 18 months|Changes in cardiovascular marker Calciprotein Particles (CPP)/T50, Changes between baseline and 18 months as well as differences between treated and controls., Baseline and 18 months|Changes in cardiovascular marker N-Terminal pro B-type Natriuretic Peptide (NT-proBNP), Changes between baseline and 18 months as well as differences between treated and controls., Baseline and 18 months|Adverse reactions, The incidence of adverse reactions in treated patients. This is examined during the entire study., From baseline to 18 months|Bone microstructure, Bone mictrostructure by micro-compyter tomography of the bone biopsy, 12 months|Bone histology, Detailed histology of underlying cellular mechanisms using a combination of immunostainings and advanced in situ hybridizations on the bone biopsy, 12 months
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| Locations: |
Aalborg University Hospital, Aalborg, 9000, Denmark|Steno Diabetes Center Copenhagen, Gentofte, 2820, Denmark|Herlev and Gentofte Hospital, Herlev Hospital, Herlev, 2730, Denmark|Odense University Hospital, Odense, 5000, Denmark
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