Osteoporosis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Male sex 50-80 years Recently diagnosed primary osteoporosis (T-score between -2.5 and -3.5, no treatment initiated yet) or a recent (clinical) vertebral fracture or two prevalent vertebral fractures independent of bone mineral density (BMD) and subjects with clinical risk factors (recent fracture and T-score * -2.0 or recent repeated falling) and a T-score
Exclusion criteria
Exclusion criteria: Contraindication to parathyroid hormone therapy: hypersensitivity to the active substrate or to any of the excipients, pre-existing hypercalcaemia, hepatic- or renal insufficiency, metabolic bone diseases other than primary osteoporosis or glucocorticoid-induced osteoporosis, unexplained elevations of alkaline phosphatase, prior external beam or implant radiation therapy to the skeleton, patients with skeletal malignancies or bone metastases ;Any medication or disease influencing bone turnover Diabetes mellitus Hypogonadism Inability to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| * undercarboxylated osteocalcin * testosterone concentrations * insulin sensitivity determined by a hyperinsulinemic euglycemic clamp | — |
Countries
Netherlands