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Bone, testosterone and glucose metabolism.


- candidate number14387
- NTR NumberNTR3859
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-feb-2013
- Secondary IDsNL42624.018.12 / 2012-005109-27; CCMO / EudraCT
- Public TitleBone, testosterone and glucose metabolism.
- Scientific TitleUndercarboxylated osteocalcin, the hypothalamic-pituitary-gonadal axis and glucose metabolism in male patients with osteoporosis.
- ACRONYMHGB-study
- hypothesisThe hypothesis is that bone influences the male gondal axis and insuline sensitivity.
- Healt Condition(s) or Problem(s) studiedOsteoporosis
- Inclusion criteria1. Male sex 50-80 years;
2. Recently diagnosed primary osteoporosis (T-score between -2.5 and -3.5);
3. Testosterone within reference range.
- Exclusion criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2013
- planned closingdate30-jun-2014
- Target number of participants8
- InterventionsThe 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 outcome1. 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 outcomeN/A
- TimepointsBaseline, 6 weeks, 12 weeks, 18 weeks, 24 weeks.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. P.H.L.T. Bisschop
- CONTACT for SCIENTIFIC QUERIESDr. P.H.L.T. Bisschop
- Sponsor/Initiator Academic Medical Center (AMC, Amsterdam)
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsNA
- Brief summaryRationale:
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.
- Main changes (audit trail)
- RECORD14-feb-2013 - 2-mrt-2013


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