Gut Peptides and Bone Remodeling in Children With Neuromuscular Disorders

NCT07254988 | Terminated

• 1 other identifier: TK-23
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

Both GIP and GLP-2 reduce bone resorption (measured as CTX) in healthy adult individuals. In this study, we will investigate whether GIP and GLP-2 reduce CTX in children with spinal muscular atrophy, duchenne muscular dystrophy, or cerebral palsy.

Conditions

Spinal Muscular Atrophy (SMA); Cerebral Palsy (CP); Duchenne Muscular Dystrophy (DMD)

Outcome Measures

Primary Outcomes (1)

• CTX

  Bone resorption measured as carboxy-terminal telopeptide of type I collagen (CTX)

  -10 to 240 minutes

Secondary Outcomes (7)

• P1NP

  -10 to 240 minutes

• PTH

  -10 to 240 minutes

• Glucose

  -10 to 240 minutes

• GIP

  -10 to 240 minutes

• GLP-2

  -10 to 240 minutes

Study Arms (3)

Meal test

EXPERIMENTAL

Oral liquid meal test

Other: Meal test

Glucose dependent insulinotropic polypeptide (GIP) + Glucagon-like-peptide 2 (GLP-2)

EXPERIMENTAL

Subcutaneous co-injection of GIP and GLP-2

Other: GIP + GLP-2

Placebo

PLACEBO COMPARATOR

Subcutaneous injection of saline

Other: Placebo

Interventions

Meal test OTHER

Ingestion of an oral liquid meal (nutridrink), 3.3 mL/kg body weight.

Meal test

GIP + GLP-2 OTHER

Subcutaneous GIP + GLP-2 injection (1 mL containing 100 microgram GIP + 1 mL containing 400 microgram GLP-2).

Glucose dependent insulinotropic polypeptide (GIP) + Glucagon-like-peptide 2 (GLP-2)

Placebo OTHER

Subcutaneous saline injection (2 mL isotonic saline).

Placebo

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \- Diagnosis with Cerebral palsy (CP), Duchenne muscular dystrophy (DMD) or Spinal muscular atrophy (SMA) resulting in the need of a wheelchair

You may not qualify if:

• Use of anti-resorptive medication
• Confounding illnesses
• Pregnancy
• Allergy towards the components given on the test days
• Hgb\<6.5 mmol/L

Sponsors & Collaborators

• University of Copenhagen: lead

Study Sites (1)

Rigshospitalet

Copenhagen, Denmark

Location

MeSH Terms

Conditions

Muscular Atrophy, Spinal; Cerebral Palsy; Muscular Dystrophy, Duchenne

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; Neuromuscular Diseases; Brain Damage, Chronic; Brain Diseases; Muscular Dystrophies; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Mette Marie Rosenkilde

  University of Copenhagen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: November 28, 2025
• Study Start: March 24, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)