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. 2014 Jan 10;2014(1):CD007470. doi: 10.1002/14651858.CD007470.pub3

Harwood 2004.

Methods The Nottingham Neck of Femur Study (NONOF).
Randomised controlled trial, using parallel group design (four intervention groups).
Participants Country: United Kingdom.
Number of participants randomised: 150 previously independent elderly women, 67 to 92 (mean 81.2) years of age, recruited following surgery for hip fracture.
Inclusion criteria: elderly women post‐hip fracture, previous community residence, independence in activities of daily living.
Exclusion criteria: institutionalised patients, diseases or medication known to affect bone metabolism, and those with a 10‐point abbreviated mental test score less than seven at the time of recruitment.
Interventions Participants were randomly assigned to receive:
Intervention group 1: single injection of 300,000 IU of vitamin D2 (n = 38);
Intervention group 2: single injection of 300,000 IU of vitamin D2 plus oral calcium (1000 mg) daily (n = 36);
Intervention group 3: oral vitamin D3 (800 IU) plus calcium (1000 mg) daily (n = 39);
Intervention group 4 (Control group): no treatment (n = 37);
for a one‐year period.
Outcomes The primary outcomes were bone biochemical markers, bone mineral density, and rate of falls and new fractures.
Stated aim of study "To compare the effects of different calcium and vitamin D supplementation regimens on bone biochemical markers, bone mineral density, and rate of falls in elderly women post‐hip fracture."
Notes "There were no cases of hypercalcaemia, and no participants were withdrawn because of adverse effects of trial medication."
The trial was supported by Provalis Healthcare Ltd.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Sequence generation was achieved using computer random number generation.
Allocation concealment (selection bias) Low risk Allocation was controlled by a opaque and sealed envelopes.
Blinding (performance bias and detection bias) 
 All outcomes High risk Trial was not blinded, so that the allocation was known during the trial. Placebo was not used.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk The numbers and reasons for dropouts and withdrawals in all intervention groups were described.
Selective reporting (reporting bias) Low risk Pre‐defined, or clinically relevant and reasonably expected outcomes are reported on.
Industry bias High risk The trial was supported by Provalis Healthcare Ltd.
Other bias Low risk The trial appears to be free of other components that could put it at risk of bias.