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 |