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. 2007 Jan 24;2007(1):CD001890. doi: 10.1002/14651858.CD001890.pub3

Lefebrve 1989.

Methods Country: France
 Setting/Design: Hospital, randomised trial
 Time frame: 18 months
 Randomisation method: Stratification according to prestudy bone morphology
 Blinding 
 ‐ Participants: No
 ‐ Investigators: No
 ‐ Outcome assessors: No
 ‐ Data analysis: No
 Intention‐to‐treat: Yes
 Loss to follow‐up: none
Participants INCLUSION CRITERIA
 Informed consent including 2 bone biopsies
TREATMENT GROUP
 Number: 11
 Age: 51.2 ± 9.1 years
 Sex (M/F): 5/6
 Duration of dialysis: 6.6 ± 3.3 years
CONTROL GROUP
 Number: 10
 Age: 49.9 ± 14.1 years
 Sex (M/F): 5/5
 Duration of dialysis: 6.2 ± 3.0 years
EXCLUSIONS
 Severe radiological osteitis fibrosa, plasma calcium > 11 mg/dL, parathyroidectomy, diabetes mellitus, treatment with corticosteroids
Interventions TREATMENT GROUP
 Bicarbonate added to dialysis fluid to achieve venous bicarbonate > 24 mEq/L
CONTROL GROUP
 Standard bicarbonate concentration 33 mEq/L
CO‐INTERVENTIONS
 Phosphate binder (1‐5 g aluminium gel when plasma phosphate > 6 mg/dL), calcium carbonate (up to 4 g/d to obtain plasma calcium > 9.0 mg/dL), vitamin D (up to 0.75 µg/d when 9.0 mg/dL plasma calcium level could not be achieved with 4 g calcium carbonate alone)
 Treatment group: 5 patients took antihypertensive drugs
 Control group: 6 patients took antihypertensive drugs
Outcomes Predialysis pH
 PTH (1‐84, 44‐68,53‐84)
 Pre‐ and post dialysis creatinine, sodium, calcium, phosphate measured every 2 weeks
 Plasma alkaline phosphatase, aluminium, iPTH, osteocalcin measured every 3 months
 Bone volume, osteoid volume, osteoid surfaces, osteoclast surfaces (%), osteoclasts/mm², bone formation rate, osteoid thickness
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment (selection bias) Unclear risk B ‐ Unclear