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Fracture Healing Assessed by HR-pQCT After Administration of Calcium and Vitamin D

Primary Purpose

Bone Fracture

Status

Completed

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

Calcium

Calcium + low dose vitamin D

Calcium + high dose vitamin D

About this trial

This is an interventional other trial for Bone Fracture focused on measuring Fracture healing, Calcium supplementation, Vitamin D supplementation, HR-pQCT

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Postmenopausal women older than 50 years who present themselves in clinic with a distal radius fracture due to a trauma.
Patients with a stable distal radius fracture treated by cast immobilization.
Patients who understand the conditions of the study and are willing and able to comply with the scheduled biochemical and radiographic evaluations and the prescribed rehabilitation.
Patients who signed the Ethics Committee approved specific Informed Consent Form prior to inclusion.

Exclusion Criteria:

Patients who underwent surgery of the wrist or radius on a previous occasion on the same side or who need surgery this time.
Patients with active or suspected infection such as pneumonia or complicated urinary tract infection in the last 3 months.
Patients with malignancy or a pathological fracture in the last 12 months.
Patients with a neuromuscular or neurosensory deficit, e.g. Parkinson's disease, which would limit the ability to assess the performance during the healing period.
Patients with known systemic or metabolic disorders leading to progressive bone deterioration, such as: hyperthyroidism, hyperparathyroidism, chronic kidney disease with eGFR<30 ml/min, sarcoidosis, hypercalcemia,
Patients with an active inflammatory disease during the last year such as rheumatoid arthritis, systemic lupus erythematous, inflammatory bowel disease, e.g. Crohn's disease and ulcerative colitis.
The use of glucocorticoids during the last 12 months.
Patients with an allergy to calcium, calcium carbonate, cholecalciferol, aspartame, citric-acid, lactose, dimethicone, methylcellulose, sorbic acid, macrogole, polyvidone, mannitol, orange flavour, natriumsaccharine, starch or sucrose.
Patients, who as judged by the principal Investigator, are mentally incompetent or are unlikely to be compliant with the follow-up evaluation schedule.
Patients with other severe concurrent joint involvements that can affect their outcome.
Patients who are already selected for another trial concerning distal radius fractures.

Sites / Locations

VieCuri Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

No Intervention

Active Comparator

No Intervention

Arm Label

Standard care

Calcium

Calcium and low dose vitamin D

Calcium and high dose vitamin D

Already on treatment with Calcium or vitamin D

Arm Description

Start of calcium and vitamin D3 supplementation according to standard care, i.e. 12 weeks after fracture.

Immediate administration of daily calcium supplementation (1000 mg calcium)

Immediate administration of daily calcium + low dose vitamin D supplementation (1000 mg calcium + 880 IU vitamin D).

Immediate administration of daily calcium + high dose vitamin D supplementation (1000 mg calcium + 1760 IU vitamin D)

Patients who are already treated with Calcium or Vitamin D.

Outcomes

Primary Outcome Measures

Bone strength

Bone strength parameters will be assessed by HRpQCT

Secondary Outcome Measures

Fracture healing

Functional outcome assessed by PRWE

Functional outcome is assessed using Patient-Related Wrist Examination (PRWE) questionnaire

Functional outcome assessed by QuickDASH

Functional outcome is assessed using QuickDASH questionnaires

Functional outcome assessed using VAS for pain score

Functional outcome is assessed using VAS for pain score on Visual Analogue Scale (VAS)

Functional outcome assessed using range of motion

Functional outcome is assessed by measuremt of range of motion of the fractured wrist

Full Information

NCT ID

NCT02889237

First Posted

September 26, 2014

Last Updated

November 16, 2021

Sponsor

VieCuri Medical Centre

1. Study Identification

Unique Protocol Identification Number

NCT02889237

Brief Title

Fracture Healing Assessed by HR-pQCT After Administration of Calcium and Vitamin D

Official Title

Assessment of Fracture Healing by High-resolution Peripheral Quantitative Computed Tomography (HR-pQCT) and Bone Strength Analysis in Standard Care and After Immediate Administration of Calcium and Vitamin D Supplementation

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

October 2014 (undefined)

Primary Completion Date

June 18, 2020 (Actual)

Study Completion Date

June 18, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

VieCuri Medical Centre

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study is designed as a single-blind RCT in 80 postmenopausal women to compare the effect of immediate administration of daily calcium supplementation (1000 mg calcium) or two daily dosages of calcium + vitamin D (1000 mg calcium + 880 IU vitamin D or 1000 mg calcium + 1760 IU vitamin D) to standard care (administration of vitamin D3 12 weeks after fracture) in terms of calculated bone strength based on analysis of cortical and trabecular bone parameters using HR-pQCT, fracture healing and functional outcome.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bone Fracture

Keywords

Fracture healing, Calcium supplementation, Vitamin D supplementation, HR-pQCT

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

52 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard care

Arm Type

No Intervention

Arm Description

Start of calcium and vitamin D3 supplementation according to standard care, i.e. 12 weeks after fracture.

Arm Title

Calcium

Arm Type

Active Comparator

Arm Description

Immediate administration of daily calcium supplementation (1000 mg calcium)

Arm Title

Calcium and low dose vitamin D

Arm Type

Active Comparator

Arm Description

Immediate administration of daily calcium + low dose vitamin D supplementation (1000 mg calcium + 880 IU vitamin D).

Arm Title

Calcium and high dose vitamin D

Arm Type

Active Comparator

Arm Description

Immediate administration of daily calcium + high dose vitamin D supplementation (1000 mg calcium + 1760 IU vitamin D)

Arm Title

Already on treatment with Calcium or vitamin D

Arm Type

No Intervention

Arm Description

Patients who are already treated with Calcium or Vitamin D.

Intervention Type

Dietary Supplement

Intervention Name(s)

Calcium

Other Intervention Name(s)

Cacit effervescent tablet '1000'

Intervention Description

Immediate administration of daily calcium supplementation for 12 weeks

Intervention Type

Dietary Supplement

Intervention Name(s)

Calcium + low dose vitamin D

Other Intervention Name(s)

CaD® sachet 1000/880

Intervention Description

Immediate administration of daily calcium and low dose vitamin D (1 sachet CaD 1000/880) supplementation for 12 weeks

Intervention Type

Dietary Supplement

Intervention Name(s)

Calcium + high dose vitamin D

Other Intervention Name(s)

CaD® sachets 500/880

Intervention Description

Immediate administration of daily calcium and high dose vitamin D (2 sachets CaD 500/880) supplementation for 12 weeks

Primary Outcome Measure Information:

Title

Bone strength

Description

Bone strength parameters will be assessed by HRpQCT

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Fracture healing

Time Frame

1 year

Title

Functional outcome assessed by PRWE

Description

Functional outcome is assessed using Patient-Related Wrist Examination (PRWE) questionnaire

Time Frame

1 year

Title

Functional outcome assessed by QuickDASH

Description

Functional outcome is assessed using QuickDASH questionnaires

Time Frame

1 year

Title

Functional outcome assessed using VAS for pain score

Description

Functional outcome is assessed using VAS for pain score on Visual Analogue Scale (VAS)

Time Frame

1 year

Title

Functional outcome assessed using range of motion

Description

Functional outcome is assessed by measuremt of range of motion of the fractured wrist

Time Frame

1 year

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Postmenopausal women older than 50 years who present themselves in clinic with a distal radius fracture due to a trauma. Patients with a stable distal radius fracture treated by cast immobilization. Patients who understand the conditions of the study and are willing and able to comply with the scheduled biochemical and radiographic evaluations and the prescribed rehabilitation. Patients who signed the Ethics Committee approved specific Informed Consent Form prior to inclusion. Exclusion Criteria: Patients who underwent surgery of the wrist or radius on a previous occasion on the same side or who need surgery this time. Patients with active or suspected infection such as pneumonia or complicated urinary tract infection in the last 3 months. Patients with malignancy or a pathological fracture in the last 12 months. Patients with a neuromuscular or neurosensory deficit, e.g. Parkinson's disease, which would limit the ability to assess the performance during the healing period. Patients with known systemic or metabolic disorders leading to progressive bone deterioration, such as: hyperthyroidism, hyperparathyroidism, chronic kidney disease with eGFR<30 ml/min, sarcoidosis, hypercalcemia, Patients with an active inflammatory disease during the last year such as rheumatoid arthritis, systemic lupus erythematous, inflammatory bowel disease, e.g. Crohn's disease and ulcerative colitis. The use of glucocorticoids during the last 12 months. Patients with an allergy to calcium, calcium carbonate, cholecalciferol, aspartame, citric-acid, lactose, dimethicone, methylcellulose, sorbic acid, macrogole, polyvidone, mannitol, orange flavour, natriumsaccharine, starch or sucrose. Patients, who as judged by the principal Investigator, are mentally incompetent or are unlikely to be compliant with the follow-up evaluation schedule. Patients with other severe concurrent joint involvements that can affect their outcome. Patients who are already selected for another trial concerning distal radius fractures.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

J PW van den Bergh, MD, PhD

Organizational Affiliation

VieCuri Medical Centre

Official's Role

Principal Investigator

Facility Information:

Facility Name

VieCuri Medical Centre

City

Venlo

State/Province

Limburg

ZIP/Postal Code

5912BL

Country

Netherlands

12. IPD Sharing Statement

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Fracture Healing Assessed by HR-pQCT After Administration of Calcium and Vitamin D

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