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. 2014 Mar 13;2014(3):CD002010. doi: 10.1002/14651858.CD002010.pub4

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.
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).
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).
Outcomes
  • BMD lumbar spine, proximal femur (total hip) (at 0, 6 months; DXA Hologic QDR 4500 Waltham MA)

  • BMD distal radius, ultra distal radius (at 0, 6 months; SXA)

  • Adverse events (bone pain)

  • Withdrawals (total, due to adverse events)

  • Survival

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.