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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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). |
|
| 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) |
|
| Already on treatment with Calcium or vitamin D | No Intervention | Patients who are already treated with Calcium or Vitamin D. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcium | Dietary Supplement | Immediate administration of daily calcium supplementation for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bone strength | Bone strength parameters will be assessed by HRpQCT | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Fracture healing | 1 year | |
| Functional outcome assessed by PRWE | Functional outcome is assessed using Patient-Related Wrist Examination (PRWE) questionnaire | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| J PW van den Bergh, MD, PhD | VieCuri Medical Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VieCuri Medical Centre | Venlo | Limburg | 5912BL | Netherlands |
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| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D002118 | Calcium |
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
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| 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 |
|
|
| 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 |
|
|
| Functional outcome assessed by QuickDASH | Functional outcome is assessed using QuickDASH questionnaires | 1 year |
| Functional outcome assessed using VAS for pain score | Functional outcome is assessed using VAS for pain score on Visual Analogue Scale (VAS) | 1 year |
| Functional outcome assessed using range of motion | Functional outcome is assessed by measuremt of range of motion of the fractured wrist | 1 year |
| D001779 |
| Blood Coagulation Factors |
| D001685 | Biological Factors |
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |