Haworth 2001.
Methods | Randomised controlled trial; parallel design. Trial duration planned for 1 year, but was shortened to 6 months because of adverse events. Single centre, UK. |
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Participants | Inclusion criteria: CF; no organ transplantation; 70% of all eligible participants in a longitudinal BMD study recruited after one year of follow‐up; no prior treatment with bone‐sparing agents; BMD z score of ≦ ‐2 at lumbar spine, proximal femur or distal forearm. Total participants: n = 31 (9 female); mean (SD) age 26.1 (5.8) years; mean (SD) BMI 21.1 (2.7) kg/m2; mean (SD) FEV1 50.9 (20.3) % of predicted treatment. Groups similar with respect to age, initial BMD, bone biochemistry and respiratory disease severity. Treatment group: n = 15 (more females in this group but exact number not reported) control group: n = 16 3 participants did not complete the study (1 participant in the treatment group received a double lung transplant and 1 participant in each group died of respiratory failure). |
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Interventions | Treatment group: intravenous pamidronate 30 mg every 3 months for 6 months (2 doses) plus oral calcium (1 g daily) Control group: oral calcium (1 g daily) All participants with pancreatic insufficiency (relevant to all except one in control group) continued long‐term oral vitamin D (900 IU/day). |
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Outcomes |
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Notes | Received funding from the CF Trust in the UK. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Described as randomised, but process not reported. |
Allocation concealment (selection bias) | Unclear risk | Not discussed. |
Blinding (performance bias and detection bias) All outcomes | High risk | Not possible to blind as they did not give placebo infusions, so patients and clinicians would know who was in the treatment group and who in the control group. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Withdrawals were reported; 1 participant in each group died of respiratory failure and 1 participant in the treatment group underwent a double lung transplant. |
Selective reporting (reporting bias) | Low risk | Outcome measures that were described in the methods section were reported in the results section. |
Other bias | High risk | Trial duration planned for 1 year, but was shortened to 6 months because of adverse events. |