The hypothesis is that bone influences the male gondal axis and insuline sensitivity.
ID
Bron
Verkorte titel
Aandoening
Osteoporosis
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. Undercarboxylated osteocalcin;<br>
2. Testosterone concentrations;<br>
3. Glucose tolerance determined by an oral glucose tolerance test;<br>
4. Insulin sensitivity determined by a hyperinsulinemic euglycemic clamp.
Achtergrond van het onderzoek
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.
Study design:
Open label randomized controlled cross-over trial.
Study population:
Male objects with recently diagnosed primary osteoporosis.
Intervention:
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.
Doel van het onderzoek
The hypothesis is that bone influences the male gondal axis and insuline sensitivity.
Onderzoeksopzet
Baseline, 6 weeks, 12 weeks, 18 weeks, 24 weeks.
Onderzoeksproduct en/of interventie
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).
Publiek
P.H.L.T. Bisschop
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5666071
p.h.bisschop@amc.uva.nl
Wetenschappelijk
P.H.L.T. Bisschop
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5666071
p.h.bisschop@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Male sex 50-80 years;
2. Recently diagnosed primary osteoporosis (T-score between -2.5 and -3.5);
3. Testosterone within reference range.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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;
4. Hypogonadism;
5. Inability to give informed consent.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL3689 |
NTR-old | NTR3859 |
CCMO | NL42624.018.12 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |
OMON | NL-OMON41473 |