No registrations found.
ID
Source
Brief title
Health condition
Osteoporosis
Sponsors and support
Intervention
Outcome measures
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
Background 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.
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.
Study objective
The hypothesis is that bone influences the male gondal axis and insuline sensitivity.
Study design
Baseline, 6 weeks, 12 weeks, 18 weeks, 24 weeks.
Intervention
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).
P.H.L.T. Bisschop
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5666071
p.h.bisschop@amc.uva.nl
P.H.L.T. Bisschop
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5666071
p.h.bisschop@amc.uva.nl
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;
4. Hypogonadism;
5. Inability to give informed consent.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3689 |
| NTR-old | NTR3859 |
| CCMO | NL42624.018.12 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON41473 |