Harwood 2004.
Methods | The Nottingham Neck of Femur Study (NONOF). Randomised controlled trial, using parallel group design (four intervention groups). |
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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. |
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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. |
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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Notes | "There were no cases of hypercalcaemia, and no participants were withdrawn because of adverse effects of trial medication."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. |
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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. |