Short summary

The objectives in this study are to evaluate the effect and the efficacy of using teriparatide as a treatment for adynamic bone disorder in patients with CKD (and examine the subacute changes in mineral metabolism during treatment with teriparatide), as well as to examine how teriparatide affects bone histomorphometry and cardiovascular markers in these patients. We wish to compare the difference in changes between the group treated with teriparatide and the untreated group.

Rationale

As kidney function declines, fracture risk increases. In patients with end stage kidney disease, the risk of fracture is 2-3 times the risk in the Danish background population. Furthermore, patients with chronic kidney diease (CKD) have a higher risk of death, and a prolonged hospitalisation after fracture. Patients with CKD develops disturbances in mineral metabolism, which may lead to impairment of bone strength and increase fracture risk, but also lead to an increased risk of cardiovascular disease. The bone histologic changes in patients with CKD varies from high turnover to low turnover, all increasing fracture risk. As of now, no current anti-osteoporotic treatment is available for patients with an estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m2, leaving our patients untreated with an increased fracture risk. We wish to explore if treatment with teriparatide once a day can increase a specific bone formation marker (bone specific alkaline phosphatase (BSAP)), improve bone density, microarchitecture and bone morphology and also improve cardiovascular parameters.

Description of the cohort

Patients with: A) eGFR < 30 ml/min/1.73m2, AND B) increased fracture risk due to low bone mass density (T-score ≤-2 or Z-score ≤-2) and/or former fragility fracture AND C) suspected adynamic bone disorder based on BSAP ≤21 µg/l. They will be recruited from different outpatient clinics

Data and biological material

Blood and urine samples will be collected. Different data such as demographic data, medical history, co-morbidity, concomitant medication and so on will be registrered. Tissue from bone biopsies will collected.

Collaborating researchers and departments

Department of Nephrology, Herlev Hospital

• Ditte Hansen, associate professor MD PhD
• Marie Frimodt-Møller, MD PhD

Department of Endocrinology, Odense University Hospital

• Morten Frost Nielsen, associate professor MD PhD

Department of Nephrology, Odense University Hospital

• Subagini Nagarajah, MD PhD

Department of Clinical Biochemistry, Rigshospitalet Glostrup

• Niklas Rye Jørgensen, professor MD PhD

Department of Pathology, Odense University Hospital and Department of Clinical Research, University of Southern Denmark

• Thomas Levin Andersen, associate professor PhD

Department of Endocrinology, Herlev Hospital

• Jakob Præst Holm, MD PhD

Department of Clinical Physiology, Herlev Hospital

• Bent Kristensen, MD MSc
• Dan Fuglø, MD PhD

Steno Diabetes Center Copenhagen

• Frederik Persson, MD, DMSc.