Bone FractureNCT02889237
Fracture Healing Assessed by HR-pQCT After Administration of Calcium and Vitamin D
A study testing Calcium, Calcium + low dose vitamin D and Calcium + high dose vitamin D in people with Bone Fracture, run by VieCuri Medical Centre at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Bone Fracture
- What is being tested?
- Calcium, Calcium + low dose vitamin D and Calcium + high dose vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2014to 18 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Calcium, Calcium + low dose vitamin D, Calcium + high dose vitamin D
- Keywords
- Fracture healing, Calcium supplementation, Vitamin D supplementation, HR-pQCT
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CalciumDietary supplement
Also called Cacit effervescent tablet '1000'
Immediate administration of daily calcium supplementation for 12 weeks
Calcium + low dose vitamin DDietary supplement
Also called CaD® sachet 1000/880
Immediate administration of daily calcium and low dose vitamin D (1 sachet CaD 1000/880) supplementation for 12 weeks
Calcium + high dose vitamin DDietary supplement
Also called CaD® sachets 500/880
Immediate administration of daily calcium and high dose vitamin D (2 sachets CaD 500/880) supplementation for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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). Receives: 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) Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone strength
Bone strength parameters will be assessed by HRpQCT
Measured: 1 year
Secondary outcomes (5)
Fracture healing
Measured: 1 year
Functional outcome assessed by PRWE
Functional outcome is assessed using Patient-Related Wrist Examination (PRWE) questionnaire
Measured: 1 year
Functional outcome assessed by QuickDASH
Functional outcome is assessed using QuickDASH questionnaires
Measured: 1 year
Functional outcome assessed using VAS for pain score
Functional outcome is assessed using VAS for pain score on Visual Analogue Scale (VAS)
Measured: 1 year
Functional outcome assessed using range of motion
Functional outcome is assessed by measuremt of range of motion of the fractured wrist
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2016 (estimated)
- Study startOct 2014
- Primary completion18 Jun 2020
- Study completion18 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- VieCuri Medical Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joop P.W. van den Bergh, VieCuri Medical Centre
- Investigators
- J PW van den Bergh, MD, PhD, Principal investigator, VieCuri Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02889237
- Sponsor's protocol ID
- NL46035.072.13
- Status last verified
- Nov 2021
- First submitted
- 26 Sep 2014
- Last updated
- 26 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02889237
- Acronym / sponsor ID
- NL46035.072.13
- Conditions
- Bone Fracture
- Keywords
- Fracture healing, Calcium supplementation, Vitamin D supplementation, HR-pQCT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- VieCuri Medical CentreUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- 18 Jun 2020 (actual)
- Study completion
- 18 Jun 2020 (actual)
- First posted
- 5 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Standard care | No intervention | –Start of calcium and vitamin D3 supplementation according to standard care, i.e. 12 weeks after fracture. |
| Calcium | Active comparator | Dietary Supplement: CalciumImmediate administration of daily calcium supplementation (1000 mg calcium) |
| Calcium and low dose vitamin D | Active comparator | Dietary Supplement: Calcium + low dose vitamin DImmediate administration of daily calcium + low dose vitamin D supplementation (1000 mg calcium + 880 IU vitamin D). |
| Calcium and high dose vitamin D | Active comparator | Dietary Supplement: Calcium + high dose vitamin DImmediate administration of daily calcium + high dose vitamin D supplementation (1000 mg calcium + 1760 IU vitamin D) |
| Already on treatment with Calcium or vitamin D | No intervention | –Patients who are already treated with Calcium or Vitamin D. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CalciumAlso: Cacit effervescent tablet '1000'Immediate administration of daily calcium supplementation for 12 weeks | Dietary supplement | Calcium |
| Calcium + low dose vitamin DAlso: CaD® sachet 1000/880Immediate administration of daily calcium and low dose vitamin D (1 sachet CaD 1000/880) supplementation for 12 weeks | Dietary supplement | Calcium and low dose vitamin D |
| Calcium + high dose vitamin DAlso: CaD® sachets 500/880Immediate administration of daily calcium and high dose vitamin D (2 sachets CaD 500/880) supplementation for 12 weeks | Dietary supplement | Calcium and high dose vitamin D |
Primary outcome
Bone strength
Time frame: 1 year
Bone strength parameters will be assessed by HRpQCT
5 secondary outcomes
Fracture healing
Time frame: 1 year
Functional outcome assessed by PRWE
Time frame: 1 year
Functional outcome assessed by QuickDASH
Time frame: 1 year
Functional outcome assessed using VAS for pain score
Time frame: 1 year
Functional outcome assessed using range of motion
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J PW van den Bergh, MD, PhD principal investigator
VieCuri Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calcium, Calcium + low dose vitamin D and Calcium + high dose vitamin D in people with Bone Fracture, run by VieCuri Medical Centre at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone strength (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2021.