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

NCT02889237 | Completed

• 1 other identifier: NL46035.072.13
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Fracture

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Bone strength

  Bone strength parameters will be assessed by HRpQCT

  1 year

Secondary Outcomes (5)

• Fracture healing

  1 year

• Functional outcome assessed by PRWE

  1 year

• Functional outcome assessed by QuickDASH

  1 year

• Functional outcome assessed using VAS for pain score

  1 year

• Functional outcome assessed using range of motion

  1 year

Study Arms (5)

Standard care

NO INTERVENTION

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

Calcium

ACTIVE COMPARATOR

Immediate administration of daily calcium supplementation (1000 mg calcium)

Dietary Supplement: Calcium

Calcium and low dose vitamin D

ACTIVE COMPARATOR

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

Dietary Supplement: Calcium + low dose vitamin D

Calcium and high dose vitamin D

ACTIVE COMPARATOR

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

Dietary Supplement: Calcium + high dose vitamin D

Already on treatment with Calcium or vitamin D

NO INTERVENTION

Patients who are already treated with Calcium or Vitamin D.

Interventions

Calcium DIETARY_SUPPLEMENT

Immediate administration of daily calcium supplementation for 12 weeks

Also known as: Cacit effervescent tablet '1000'

Calcium

Calcium + low dose vitamin D DIETARY_SUPPLEMENT

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

Also known as: CaD® sachet 1000/880

Calcium and low dose vitamin D

Calcium + high dose vitamin D DIETARY_SUPPLEMENT

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

Also known as: CaD® sachets 500/880

Calcium and high dose vitamin D

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VieCuri Medical Centre: lead

Study Sites (1)

VieCuri Medical Centre

Venlo, Limburg, 5912BL, Netherlands

Location

MeSH Terms

Conditions

Fractures, Bone

Interventions

Calcium; Vitamin D

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• J PW van den Bergh, MD, PhD

  VieCuri Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr. J.P.W. van den Bergh, Endocrinologist

Study Record Dates

• First Submitted: September 26, 2014
• First Posted: September 5, 2016
• Study Start: October 1, 2014
• Primary Completion: June 18, 2020
• Study Completion: June 18, 2020
• Last Updated: November 26, 2021

Record last verified: 2021-11

Locations

NL (1)