bone metabolism MedDRA version: 18.0 Level: HLT Classification code 10067225 Term: Biochemical markers of bone metabolism System Organ Class: 100000004848
Conditions
Interventions
Trade Name: Bydureon
Pharmaceutical Form: Powder and solvent for prolonged-release suspension for injection
INN or Proposed INN: EXENATIDE
CAS Number: 141758-74-9
Concentration unit: mg milligram(s)
C
Sponsors
Endocrine Research Unit, Odense University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: healthy postmenopausal women Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 66 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 66
Exclusion criteria
Exclusion criteria: -primary hyperparathyroidism - treatment with metformin or any other drug used for the treatment of type 2 diabetes, antiresorptive drugs, glucocorticoids, aromatase inhibitors, HRT, anti-epileptic drugs - diseases associated with osteoporosis including RA, renal insufficiency, thyreotoxicosis, type 1 diabetes, severe COPD - pancreatitis - fractures < 6 months - allergy towards exenatide - excessive intake of alcohol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: bone formation;Secondary Objective: bone resorption and bone structure;Primary end point(s): changes in bone formation marker P1NP;Timepoint(s) of evaluation of this end point: day 8, 15, 29, 43, 57, 71, 89 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): changes in levels of CTX, bone mass, bone structure and histomophometry ;Timepoint(s) of evaluation of this end point: day 8, 15, 29, 43, 57, 71, 89 | — |
Countries
Denmark
Contacts
Public ContactM Frost
Endocrine Research Unit, University of Southern Denmark
Outcome results
None listed