OTHER
isotonic saline infusion
Placebo infusion for comparison of active hormone
Status
Not yet recruiting
Phase
Not applicable
Enrollment
15
Locations
1
Results
Not posted
Publications
0
Study summary
The goal of this clinical trial is to learn whether certain natural hormones - Glucose-dependent insulinotropic polypeptide (GIP), glucagon-like peptide-2, (GLP-2), and amylin - affect blood flow to the bones.
In this study, participants will attend four study visits. At each visit they will be given infusions with either one of these hormones (GIP, GLP-2, pramlintide (a drug that mimics the natural hormone amylin)) or a placebo infusion (salt water). At the same time, participants will undergo a PET/CT scan where they will be administered a bone tracer (sodium fluoride), to visualize bone blood flow and activity. Participants do not know whether they are given active hormone or placebo infusion.
Interventions
OTHER
Placebo infusion for comparison of active hormone
OTHER
Study tool
OTHER
Study tool
OTHER
Study tool
Timeline
First posted
Jul 1, 2026
Study start
Jul 19, 2026
Primary completion
May 2028
Study completion
May 2028
Results posted
Not reported
Registry updated
Jul 9, 2026
Outcomes
Median Ki in the Femur
Time frame · 90 minutes
Kinetic modelling
Median Ki in the lumbar spine
Time frame · 90 minutes
Kinetic modelling
Ki in other bones.
Time frame · 90 minutes
Kinetic modelling
Bone perfusion (K1)
Time frame · 90 minutes
Kinetic modelling
Bone incorporation fraction (K3/K3+K2)
Time frame · 90 minutes.
Kinetic modelling
Mean difference in CTX
Time frame · 90 minutes.
Bone turnover marker.
Mean difference in P1NP
Time frame · 90 minutes
Bone turnover marker
Mean difference in PTH.
Time frame · 90 minutes.
Bone turnover marker.
Mean difference in GIP(1-42)
Time frame · 90 minutes.
Mean difference in GLP-2(1-33)
Time frame · 90 minutes.
Mean difference in pramlintide
Time frame · 90 minutes.
Eligibility
Inclusion Criteria: 1. Age 25-50 years. 2. BMI between 18.5-30 kg/m2. 3. Normal gait. 4. Premenopausal (if female). 5. Informed consent. Exclusion Criteria: 1. Bone disease incl. confirmed osteopenia. 2. Fracture within the last 6 months at the time of inclusion. 3. Amputation or congenital defect of extremities. 4. HbA1c\>41.9 mmol/mol and/or diagnosed type 1 or type 2 diabetes. 5. Any ongoing or prior medication that the investigator evaluates could interfere with the endpoints of the study (e.g. glucocorticoids or other medications that may compromise bone health). 6. Pregnancy or breastfeeding (or plans thereof within the study duration). 7. Not using effective hormonal contraceptives or an intra uterine device within study duration (e.g. oral contraceptives, transdermal patch, vaginal ring, Depo-Provera injections, Nexplanon implant). 8. Ongoing or prior alcohol abuse (defined per ICD-10 classification for alcohol dependence syndrome, F10.21) or daily alcohol intake 9. Use of any illicit substance or narcotics within three months of inclusion, including within study duration. 10. Any physical or psychological condition that the investigator evaluates would interfere with trial participation. 11. Recent (three months prior to inclusion), ongoing or planned weight loss within study duration (weight loss defined as exceeding -5% bodyweight, or intentional hypocaloric dieting)
Study locations
Denmark. Showing up to 24 locations stored in the fast local snapshot.
Rigshospitalet
Copenhagen, Denmark
Publications
No PMID-linked publications were present in this registry snapshot.
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