A Randomised, Controlled Comparison of Vitamin D Strategies is Acute Hip Fracture Patients

NCT00424619 | Completed Phase 4 Results

• 2 other identifiers: 06-449P1975
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the study is to determine the best dose of Vitamin D to give to hip fracture patients to achieve the optimal therapeutic level.

Conditions

Hip Fracture

Keywords

Vitamin D; Hip fracture; Optimal level; Deficiency; Functional muscle strength

Outcome Measures

Primary Outcomes (7)

• 25-hydroxyvitamin D3 (25-OHD)

  Serum 25-hydroxyvitamin D3 (25-OHD) was measured at baseline, at discharge from hospital (approximately 4-weeks), and at a follow-up study visit at approximately 3-months.Baseline and 4-week blood samples were drawn in-hospital; venipunctures performed at 3-months were either in-hospital (if patient remained in acute care or rehabilitation) or at the out-patient clinic visit.Serum 25-OHD was analyzed with the DiaSorin, 25-hydroxyvitamin D radioimmunoassay (Stillwater, Minnesota 55082-0285, U.S.A) at the central laboratory with the exception of 3 patients (data analyzed at other laboratories).

  Baseline, 4 weeks and 3 months

• Parathyroid Hormone (PTH)

  Baseline blood samples were drawn in-hospital. In additional PTH was accessed at baseline.

  Baseline

• Calcium

  Baseline blood samples were drawn in-hospital. In additional Calcium was accessed at baseline and approximately 4 weeks.

  Baseline, 4 weeks

• Phosphate

  Baseline blood samples were drawn in-hospital. In additional phosphate was accessed at baseline.

  Baseline

• Alkaline Phosphatase

  Baseline blood samples were drawn in-hospital. In additional Alkaline Phosphatase was accessed at baseline.

  Baseline

• Hemoglobin

  Baseline blood samples were drawn in-hospital. In additional hemoglobin was accessed at baseline.

  Baseline

• Creatinine

  Baseline blood samples were drawn in-hospital. In additional creatinine was accessed at baseline.

  Baseline

Secondary Outcomes (2)

• Functional Assessment Using the Timed Up and Go (TUG) Test After 3 Months

  3 months

• Functional Assessment Using the Two Minute Walk Test (2MWT)After 3 Months

  3 months

Study Arms (3)

1

ACTIVE COMPARATOR

50 000 IU Vitamin D2

Drug: Vitamin D2

2

ACTIVE COMPARATOR

100 000 IU Vitamin D2

Drug: Vitamin D2

3

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Vitamin D2 DRUG

50 000 IU vitamin D2, one time bolus dose

Also known as: Ostoforte

1

Placebo DRUG

Placebo, 1 time bolus dose

3

Eligibility Criteria

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

You may qualify if:

• Fragility hip fracture patient
• Previous Vitamin D supplementation is okay.

You may not qualify if:

• Patients with pathological fracture secondary to malignancy or intrinsic bone disease (eg. Paget's disease)
• Cancer in the past 10 years likely to metastasize to bone
• Renal insufficiency (creatinine \<30 mls/min)
• Hypercalcemia (primary hyperparathyroidism; granulomatous diseases; drug-induced such as lithium, thiazides), hypocalcemia, hypercalciuria, fracture or stroke within the last 3 months
• Hormone replacement therapy, calcitonin, fluoride, or bisphosphonates during the previous 24 months
• Pre-existing bone abnormality
• Renal stones in past 10 years

Sponsors & Collaborators

• McMaster University: lead
• Merck Frosst Canada Ltd.: collaborator

Related Publications (1)

• Papaioannou A, Kennedy CC, Giangregorio L, Ioannidis G, Pritchard J, Hanley DA, Farrauto L, DeBeer J, Adachi JD. A randomized controlled trial of vitamin D dosing strategies after acute hip fracture: no advantage of loading doses over daily supplementation. BMC Musculoskelet Disord. 2011 Jun 20;12:135. doi: 10.1186/1471-2474-12-135.

  PMID: 21689448 DERIVED

MeSH Terms

Conditions

Hip Fractures

Interventions

Ergocalciferols

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Results Point of Contact

• Title: Dr. Alexandra Papaioannou
• Organization: McMaster University

papaioannou@hhsc.ca

905-521-2100

Study Officials

• Alexandra Papaioannou, M.D., M.Sc.

  McMaster University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Alexandra Papaioannou

Study Record Dates

• First Submitted: January 17, 2007
• First Posted: January 19, 2007
• Study Start: October 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: July 16, 2025
• Results First Posted: June 14, 2012

Record last verified: 2012-05