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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
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON41473
Enrollment
8
Registered
2012-11-22
Start date
2013-02-06
Completion date
Unknown
Last updated
2025-03-24

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. Group 1 will first receive subcutaneous Teriparatide 20*g daily (12 weeks) and then no treatment Group 2 will fi

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 (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

MeasureTime frame
* undercarboxylated osteocalcin * testosterone concentrations * insulin sensitivity determined by a hyperinsulinemic euglycemic clamp

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)