Failure of oral pamidronate to reduce skeletal morbidity in multiple myeloma: a double-blind placebo-controlled trial. Danish-Swedish co-operative study group.
In order to study whether oral bisphosphonate therapy might prevent or reduce skeletal-related morbidity in patients with newly diagnosed multiple myeloma who required chemotherapy, 300 patients were included in a randomized multi-centre trial. Patients were given oral pamidronate at a dose of 300 mg daily, or placebo, in addition to conventional intermittent melphalan/prednisolone (and in some cases alpha-interferon) treatment. With a median treatment duration of about 550d, no statistically significant reduction in skeletal-related morbidity (defined as bone fracture, related surgery, vertebral collapse, or increase in number and/or size of bone lesions) could be demonstrated. Pamidronate treatment also did not have any influence on patient survival or on the frequency of hypercalcaemia. However, in patients treated with pamidronate there were fewer episodes of severe pain (P=0.02) and a decreased reduction of body height of 1.5 cm (P= 0.02). The overall negative result of the study is attributed to the very low absorption of orally administered bisphosphonates in general.
Brincker
H
H
Department of Haematology, Odense University Hospital, Denmark.
Westin
J
J
Abildgaard
N
N
Gimsing
P
P
Turesson
I
I
Hedenus
M
M
Ford
J
J
Kandra
A
A
D000284:Administration, Oral; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001827:Body Height / Q000187:drug effects; D001847:Bone Diseases / Q000517:prevention & control*; D004164:Diphosphonates / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D050723:Fractures, Bone / Q000517:prevention & control; D006801:Humans; D006934:Hypercalcemia / Q000209:etiology; D008297:Male; D008558:Melphalan / Q000008:administration & dosage; D009101:Multiple Myeloma / Q000150:complications / Q000188:drug therapy* / Q000532:radiotherapy; D010146:Pain / Q000517:prevention & control; D000077268:Pamidronate; D011239:Prednisolone / Q000008:administration & dosage; D017211:Treatment Failure
D000893:Anti-Inflammatory Agents; D004164:Diphosphonates; D011239:Prednisolone; D000077268:Pamidronate; D008558:Melphalan