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

Completed

• Conditions: Osteoporosis; 10018424; 10005959; 10018515

• Registration Number: NL-OMON41473
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 8

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 < -2.5.
Testosterone within reference range

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>* undercarboxylated osteocalcin<br /><br>* testosterone concentrations<br /><br>* insulin sensitivity determined by a hyperinsulinemic euglycemic clamp</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>NA</p><br>