Gut Peptides and Bone Remodeling in Children With Neuromu... | NCT07254988

Studies
Gut Peptides and Bone Remodeling in Children With Neuromuscular Disorders

NCT07254988

Sponsor

University of Copenhagen

Status

Terminated

Last Update Posted

Apr 16, 2026Actual

Enrollment

3Actual

Phase

Not Applicable

Conditions

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

Interventions

Meal test
GIP + GLP-2
Placebo

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Terminated since further recruitment proved difficult

Expanded Access Info

Start Date

Mar 24, 2023Actual

Primary Completion Date

Dec 1, 2025Actual

Completion Date

Dec 1, 2025Actual

First Submitted Date

Nov 19, 2025

First Submission Date that Met QC Criteria

Nov 19, 2025

First Posted Date

Nov 28, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 13, 2026

Last Update Posted Date

Apr 16, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

3Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Meal test	Other	Ingestion of an oral liquid meal (nutridrink), 3.3 mL/kg body weight.	Meal test

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
CTX	Bone resorption measured as carboxy-terminal telopeptide of type I collagen (CTX)	-10 to 240 minutes

Secondary Outcomes

Measure	Description	Time Frame
P1NP	Bone formation measured as procollagen type I N-terminal propeptide (P1NP)	-10 to 240 minutes
PTH	Parathyroid hormone (PTH) measured in plasma

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mette Marie Rosenkilde	University of Copenhagen	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rigshospitalet		Copenhagen			Denmark

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009134	Muscular Atrophy, Spinal
D002547	Cerebral Palsy
D020388	Muscular Dystrophy, Duchenne

Ancestor Terms

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D016472	Motor Neuron Disease

Browse Leaves

Not provided

Browse Branches

Not provided