Henderson 2002.
Methods | Randomized placebo controlled trial Stated as double‐blinded Loss to follow‐up: 1 pair (2 subjects) Trial Duration: 1 year |
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Participants | Inclusion criteria: non‐ambulatory children and adolescents with quadriplegic cerebral palsy Pairs matched for age, gender, sex Sample Size 12 subjects (6‐matched pairs), 1 pair lost to follow‐up Mean age: pamidronate 9.25 years, placebo 9.31 years Female/Male: pamidronate 3/3, placebo 2/4 |
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Interventions | Intravenous pamidronate or saline placebo administered daily for 3 consecutive days, repeated at 3‐month intervals for 1 year (5 dosing sessions, 15 total doses). Dose: 1 mg pamidronate/kg body weight but not <15 mg or >30mg. All subjects received daily calcium (1000mg), pediatric multivitamin, and vitamin D (400 IU) supplementation |
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Outcomes | BMD of distal femur ‐ 3 sites (raw/% change, Z‐score change) areal BMD of lumbar spine (raw/%change, Z‐score change) Bone Metabolism Parameters (change) (osteocalcin, serum NTx, Alkaline Phosphatase, bone specifc alkaline phosphatase) Withdrawals due to adverse events |
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Notes | Quality Assessment: Jadad Scale = 4/5 (R 1, B 2, W 1) | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Unclear risk | B ‐ Unclear |