Daragon 1993.
Methods | Active vs placebo control study, stratified by whether bone biopsy obtained Pain measurement tools: a. Visual analogue scale b. 3‐point categorical scale Analgesic scale: analgesics consumed classified as: a. Paracetamol b. Codeine c. Morphine |
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Participants | Multiple myeloma (SII, III) Bone lesion not specified No pain requirement Co‐intervention: chemotherapy Performance status criteria: poor physical activity Other criteria: exclude renal dysfunction, severe bone marrow insufficient, age >80, cardiac failure, diabetes, gastric or duodenal ulcer, prior chemotherapy, multiple myeloma diagnosed >3 months. |
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Interventions | 1. Active arm:
Etidronate
Oral
10 mg/kg/day
4 months
49 pts 2. Control arm: Placebo 45 pts All patients receive cyclophosphamide and prednisone |
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Outcomes | 1. Pain:
a. Change in mean pain score of the group 2. Analgesic: a. Proportion of patients taking codeine/morphine Others: a. Karnofsky performance status change b. Incidence of new extraspinal mets c. Incidence of fractures d. Survival e. Change in Vertebral index f. Bone resorption as measured by urine hydroxyproline/ calcium/ creatinine levels Withdrawals Active arm: 10/49 Control arm: 6/45 Adverse effects Active arm: Skin allergy: 1 Control arm: Pancreatitis: 1 |
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Notes | QS = 3 |