Long-term controlled trial with diphosphonate in patients with osteolytic bone metastases

Lancet. 1983 Jan 22;1(8317):146-9. doi: 10.1016/s0140-6736(83)92755-1.

Abstract

Thirty-four normocalcaemic women with multiple osteolytic bone metastases from breast cancer were randomly allocated to treatment with disodium dichloromethylene diphosphonate (Cl2MDP) 1600 mg/day orally (17) or placebo (17) for 3-9 months. Fasting urinary hydroxyproline/creatinine and calcium/creatinine ratios declined in the Cl2MDP group but not in the placebo group. Four patients in the placebo group died from hypercalcaemia. New bone metastases were more common in patients on placebo and these patients also required more analgesic drugs than those on Cl2MDP. Cl2MDP seemed to reduce bone pain and bone resorption and prevent the development of hypercalcaemia caused by osteolytic metastases. The formation of new bone metastases and the growth of old ones seemed to be retarded by Cl2MDP.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Analgesics / administration & dosage
  • Antineoplastic Agents / administration & dosage
  • Bone Neoplasms / drug therapy*
  • Bone Neoplasms / metabolism
  • Bone Neoplasms / secondary
  • Bone Resorption / metabolism
  • Bone Resorption / prevention & control
  • Breast Neoplasms / drug therapy
  • Clinical Trials as Topic
  • Clodronic Acid
  • Double-Blind Method
  • Drug Therapy, Combination
  • Female
  • Humans
  • Hydrocarbons, Chlorinated / therapeutic use*
  • Methylene Chloride
  • Middle Aged
  • Osteolysis / drug therapy
  • Random Allocation
  • Time Factors

Substances

  • Analgesics
  • Antineoplastic Agents
  • Hydrocarbons, Chlorinated
  • Clodronic Acid
  • Methylene Chloride