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Undercarboxylated osteocalcin, the hypothalamic-pituitary-gonadal axis and glucose metabolism in male patients with osteoporosis.

Undercarboxylated osteocalcin, the hypothalamic-pituitary-gonadal axis and glucose metabolism in male patients with osteoporosis. - HPG-axis, glucose metabolism and bone

Status
Unknown
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON36967
Enrollment
10
Registered
2012-10-17
Start date
2012-11-01
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis

Interventions

The participants will be randomized to two treatment groups, in a cross-over design, with an one week wash-out period: Group 1 will first receive subcutaneous Teriparatide 20*g daily (12 weeks) and

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Male sex 50-80 years Recently diagnosed primary osteoporosis Testosterone within reference range

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

MeasureTime frame
* undercarboxylated osteocalcin * testosterone concentrations * glucose tolerance determined by an oral glucose tolerance test * insulin sensitivity determined by a hyperinsulinemic euglycemic clamp * changes in body composition by a whole-body DXA scan All patients will be studied at baseline and after 6 and 12 weeks of intervention. Patients will serve as their own controls.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)