## Protocol Section
### Identification Module
**NCT ID:** NCT06421597

**Acronym:** RIGID

**Brief Title:** Identifying Individuals at Risk of Glucocorticoid-Induced Impairment of Bone Disease

**Official Title:** Identifying Individuals at Risk of Glucocorticoid-Induced Impairment of Bone Disease

#### Organization Study ID Info
**ID:** 2023-506949-27-00
#### Organization
**Class:** OTHER
**Full Name:** Odense University Hospital
### Status Module
#### Completion Date
**Date:** 2025-12

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-14

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-03
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Hospital of South West Jutland

**Class:** OTHER

**Name:** University of Ulm

**Class:** OTHER

**Name:** University of Birmingham

#### Lead Sponsor

**Class:** OTHER

**Name:** Odense University Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Previous studies have shown that there is a large inter-individual variability in the degree of bone loss during glucocorticoid treatment, and while some patients experience extensive bone loss other patients' bone mass remains stable. The aim of the study is to find a biomarker that can be used to identify individuals at risk of glucocorticoid-induced bone loss. The study will include 36 healthy volunteers, that will be randomized to receive either glucocorticoid treatment or placebo. During the study blood samples, bone marrow samples, bone tissue samples, and adipose tissue samples are taken and a mixed meal test is performed.

### Conditions Module

**Conditions:**

- Osteoporosis Secondary

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 36

**Type:** ESTIMATED

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: Prednisolone

**Label:** Prednisolone group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Drug: Placebo

**Label:** Placebo group

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Prednisolone group

**Description:** prednisoline 25 mg/day for seven days

**Name:** Prednisolone

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Placebo group

**Description:** Placebo treatment for seven days

**Name:** Placebo

**Type:** DRUG

### Outcomes Module

#### Other Outcomes

**Description:** Untargeted proteomics will be used to try to identify a biomarker for individuals at risk of glucocorticoid induced bone loss

**Measure:** Biomarker

**Time Frame:** Baseline

#### Primary Outcomes

**Description:** Changes in the level of the bone turnover marker P1NP in peripheral blood from baseline to day 8

**Measure:** Procollagen type 1 N-terminal propeptide (P1NP)

**Time Frame:** Baseline to day 8

#### Secondary Outcomes

**Description:** Changes in the level of the bone turnover marker CTX in peripheral blood from baseline to day 8 and 15

**Measure:** Collagen 1 cross link C-terminal telopeptide (CTX)

**Time Frame:** Baseline to day 8 and 15

**Description:** Changes in the level of the bone turnover marker P1NP in peripheral blood from baseline to day 15

**Measure:** P1NP (baseline to day 15)

**Time Frame:** Baseline to day 15

**Description:** Changes in the levels of glucocorticoid metabolites in blood from baseline to day 8

**Measure:** Concentration of Glucocorticoid metabolites

**Time Frame:** Baseline to day 8

**Description:** Changes in gene expression in abdominal and gluteal subcutaneous adipose tissue from baseline to day 8

**Measure:** Adipose tissue

**Time Frame:** Baseline to day 8

**Description:** Changes in gene expression in bone tissue from baseline to day 8

**Measure:** Bone tissue

**Time Frame:** Baseline to day 8

**Description:** Changes in glucose levels during a mixed meal test from baseline to day 8

**Measure:** Glucose

**Time Frame:** Baseline to day 8

**Description:** Changes in c-peptid levels during a mixed meal test from baseline to day 8

**Measure:** C-peptid

**Time Frame:** Baseline to day 8

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Men and women aged 18-50 years.

Exclusion Criteria:

* Uncontrolled thyrotoxicosis
* Chronic kidney disease (eGFR \<30)
* Known Cushing's syndrome
* Previous gastric bypass and/or known ongoing malabsorption
* Severe covid-19 in the last 3 month (defined as needing dexamethasone treatment)
* Use of oral or inhaled glucocorticoids within the past year
* Menopause (defined as 1 year without menstrual bleeding)
* Pregnancy (defined as elevated HCG)
* Ongoing infection
* Allergy to prednisolone or one of the excipients
* Systematic fungal infections
* Vaccination with living or weaken viral or bacterial vaccines in patient who or immunocompromised. In these cases, prednisolone treatment should not be administered two weeks before and after vaccination
* Not able to provide informed consent (e.g., dementia, not able to understand Danish).

**Healthy Volunteers:** True

**Maximum Age:** 50 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** catharina.vind.nielsen@rsyd.dk

**Name:** Catharina Vind Nielsen, MD

**Phone:** +45 21351124

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Esbjerg

**Contacts:**

***Contact 1:***

- **Email:** catharina.vind.nielsen@rsyd.dk

- **Name:** Catharina Vind Nielsen, MD

- **Phone:** +45 21351124

- **Role:** CONTACT

**Country:** Denmark

**Facility:** Hospital of South West Jutland

**Zip:** 6700

**Location 2:**

**City:** Odense C

**Contacts:**

***Contact 1:***

- **Email:** catharina.vind.nielsen@rsyd.dk

- **Name:** Catharina Vind Nielsen, MD

- **Phone:** +45 21351124

- **Role:** CONTACT

**Country:** Denmark

**Facility:** Odense University Hospital

**Zip:** 5000

#### Overall Officials

**Official 1:**

**Affiliation:** Odense University Hospital

**Name:** Morten Frost, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Hospital of South West Jutland

**Name:** Claus Bogh Juhl, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Description:** Individual participant data will not be shared with other researchers other than collaborators. Since the data contains personal information from the study participants

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001851

- Term: Bone Diseases, Metabolic

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000008659

- Term: Metabolic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

### Condition Browse Module - Browse Leaves

- ID: M12307

- Name: Neoplasm Metastasis

- Relevance: LOW

- As Found: Unknown

- ID: M12947

- Name: Osteoporosis

- Relevance: HIGH

- As Found: Osteoporosis

- ID: M5126

- Name: Bone Diseases

- Relevance: HIGH

- As Found: Bone Disease

- ID: M5130

- Name: Bone Diseases, Metabolic

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010024

- Term: Osteoporosis

- ID: D000001847

- Term: Bone Diseases

### Intervention Browse Module - Ancestors

- ID: D000000893

- Term: Anti-Inflammatory Agents

- ID: D000005938

- Term: Glucocorticoids

- ID: D000006728

- Term: Hormones

- ID: D000006730

- Term: Hormones, Hormone Substitutes, and Hormone Antagonists

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000018931

- Term: Antineoplastic Agents, Hormonal

- ID: D000000970

- Term: Antineoplastic Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: AnEm

- Name: Antiemetics

- Abbrev: NeuroAg

- Name: Neuroprotective Agents

- Abbrev: Gast

- Name: Gastrointestinal Agents

### Intervention Browse Module - Browse Leaves

- ID: M14120

- Name: Prednisolone

- Relevance: HIGH

- As Found: High Risk

- ID: M9047

- Name: Glucocorticoids

- Relevance: LOW

- As Found: Unknown

- ID: M11749

- Name: Methylprednisolone

- Relevance: LOW

- As Found: Unknown

- ID: M1833

- Name: Methylprednisolone Acetate

- Relevance: LOW

- As Found: Unknown

- ID: M11750

- Name: Methylprednisolone Hemisuccinate

- Relevance: LOW

- As Found: Unknown

- ID: M229449

- Name: Prednisolone acetate

- Relevance: LOW

- As Found: Unknown

- ID: M211887

- Name: Prednisolone hemisuccinate

- Relevance: LOW

- As Found: Unknown

- ID: M248881

- Name: Prednisolone phosphate

- Relevance: LOW

- As Found: Unknown

- ID: M4217

- Name: Anti-Inflammatory Agents

- Relevance: LOW

- As Found: Unknown

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M9788

- Name: Hormone Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M20966

- Name: Antineoplastic Agents, Hormonal

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000011239

- Term: Prednisolone

### Misc Info Module

- Version Holder: 2024-05-31
