|- candidate number||14387|
|- NTR Number||NTR3859|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||14-feb-2013|
|- Secondary IDs||NL42624.018.12 / 2012-005109-27; CCMO / EudraCT|
|- Public Title||Bone, testosterone and glucose metabolism.|
|- Scientific Title||Undercarboxylated osteocalcin, the hypothalamic-pituitary-gonadal axis and glucose metabolism in male patients with osteoporosis.|
|- hypothesis||The hypothesis is that bone influences the male gondal axis and insuline sensitivity. |
|- Healt Condition(s) or Problem(s) studied||Osteoporosis|
|- Inclusion criteria||1. Male sex 50-80 years;|
2. Recently diagnosed primary osteoporosis (T-score between -2.5 and -3.5);
3. Testosterone within reference range.
|- Exclusion criteria||1. 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;|
2. Any medication or disease influencing bone turnover;
3. Diabetes mellitus;
5. Inability to give informed consent.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-feb-2013|
|- planned closingdate||30-jun-2014|
|- Target number of participants||8|
|- Interventions||The participants will receive Teriparatide treatment for 12 weeks and no treatment for 12 weeks in a crossover design.|
After finishing both interventions (t=12 weeks and t=24 weeks) patients will undergo an oral glucose tolerance test and a hyperinsulinemic euglycemic clamp, and whole body dual-energy X-ray absorptiometry (DXA scan).
|- Primary outcome||1. Undercarboxylated osteocalcin;|
2. Testosterone concentrations;
3. Glucose tolerance determined by an oral glucose tolerance test;
4. Insulin sensitivity determined by a hyperinsulinemic euglycemic clamp.
|- Secondary outcome||N/A|
|- Timepoints||Baseline, 6 weeks, 12 weeks, 18 weeks, 24 weeks.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Dr. P.H.L.T. Bisschop|
|- CONTACT for SCIENTIFIC QUERIES||Dr. P.H.L.T. Bisschop|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|Academic Medical Center (AMC)|
|- Brief summary||Rationale:|
Osteoporosis is a common disease that is characterized by low bone mass with microarchitectural disruption and skeletal fragility, resulting in increased risk of fracture. Normally, bone quality is maintained by a dynamic process, known as bone remodeling. Animal research shows that osteocalcin, secreted by osteoblasts, acts as a hormone and influences the male gonal axis and insuline sensitivity.
Objective of the study:
The objective of the study is to study the relationship between undercarboxylated osteocalcin levels, testosterone concentrations, glucose tolerance and insulin sensitivity in male subjects with primary osteoporosis.
Open label randomized controlled cross-over trial.
Male objects with recently diagnosed primary osteoporosis.
The participants will be randomized to two treatment groups (Teriparatide 12 weeks or no treatment 12 weeks), in a cross-over design.
Main study parameters/endpoints:
1. Undercarboxylated osteocalcin;
2. Testosterone concentrations;
3. Glucose tolerance;
4. Insulin sensitivity.
|- Main changes (audit trail)|
|- RECORD||14-feb-2013 - 2-mrt-2013|