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. 2002;2002(2):CD002068.
doi: 10.1002/14651858.CD002068.

Bisphosphonates for the relief of pain secondary to bone metastases

R Wong  1 , P J Wiffen
Affiliations

Bisphosphonates for the relief of pain secondary to bone metastases

R Wong et al. Cochrane Database Syst Rev. 2002.

Abstract

Background: Bisphosphonates form part of standard therapy for hypercalcemia and the prevention of skeletal events in some cancers. However, the role of bisphosphonates in pain relief for bony metastases remains uncertain.

Objectives: To determine the effectiveness of bisphosphonates for the relief of pain from bone metastases.

Search strategy: MEDLINE (1966-1999), EMBASE (1980-1999), CancerLit (1966-1999), the Cochrane library (Issue 1, 2000) and the Oxford Pain Database were searched using the strategy devised by the Cochrane Pain, Palliative and Supportive Care Group with additional terms 'diphosphonate', 'bisphosphonate', 'multiple myeloma' and 'bone neoplasms'. (Last search: January 2000).

Selection criteria: Randomized trials of bisphosphonates compared with open, blinded, or different doses/types of bisphosphonates in cancer patients were included where pain and/or analgesic consumption were outcome measures. Studies where pain was reported only by observers were excluded.

Data collection and analysis: Article eligibility, quality assessment and data extraction were undertaken by both reviewers. The proportions of patients with pain relief at 4, 8 and 12 weeks were assessed. The proportion of patients with analgesic reduction, the mean pain score, mean analgesic consumption, adverse drug reactions, and quality of life data were compared as secondary outcomes.

Main results: Thirty randomized controlled studies (21 blinded, four open and five active control) with a total of 3682 subjects were included. For each outcome, there were few studies with available data. For the proportion of patients with pain relief (eight studies) pooled data showed benefits for the treatment group, with an NNT at 4 weeks of 11[95% CI 6-36] and at 12 weeks of 7 [95% CI 5-12]. In terms of adverse drug reactions, the NNH was 16 [95% CI 12-27] for discontinuation of therapy. Nausea and vomiting were reported in 24 studies with a non-significant trend for greater risk in the treatment group. One study showed a small improvement in quality of life for the treatment group at 4 weeks. The small number of studies in each subgroup with relevant data limited our ability to explore the most effective bisphosphonates and their relative effectiveness for different primary neoplasms.

Reviewer's conclusions: There is evidence to support the effectiveness of bisphosphonates in providing some pain relief for bone metastases. There is insufficient evidence to recommend bisphosphonates for immediate effect; as first line therapy; to define the most effective bisphosphonates or their relative effectiveness for different primary neoplasms. Bisphosphonates should be considered where analgesics and/or radiotherapy are inadequate for the management of painful bone metastases.

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Conflict of interest statement

None known

Figures

1.1
1.1. Analysis
Comparison 1 Proportion of patients with pain relief (Blinded and open control studies), Outcome 1 Proportion of patients with pain relief at 4 weeks (blinded and open studies).
1.2
1.2. Analysis
Comparison 1 Proportion of patients with pain relief (Blinded and open control studies), Outcome 2 Proportion of patients with pain response at 8w (Blinded and open studies).
1.3
1.3. Analysis
Comparison 1 Proportion of patients with pain relief (Blinded and open control studies), Outcome 3 Proportion of patients with pain relief at 12w (Blinded and open studies).
1.4
1.4. Analysis
Comparison 1 Proportion of patients with pain relief (Blinded and open control studies), Outcome 4 Proportion of patients with pain relief with best response within 12 weeks (blinded and open studies).
2.1
2.1. Analysis
Comparison 2 Mean pain change (non standardized), Outcome 1 mean pain score at 4 weeks.
2.2
2.2. Analysis
Comparison 2 Mean pain change (non standardized), Outcome 2 mean pain score at 8 weeks.
2.3
2.3. Analysis
Comparison 2 Mean pain change (non standardized), Outcome 3 mean pain score at 12 weeks.
3.1
3.1. Analysis
Comparison 3 Proportion of patients with reduction in analgesics (Blinded and open studies), Outcome 1 Proportion of patients with reduced analgesia at 4w (Blinded and open studies).
3.2
3.2. Analysis
Comparison 3 Proportion of patients with reduction in analgesics (Blinded and open studies), Outcome 2 Proportion of patients with reduced analgesia at 12w (Blinded and open studies).
4.1
4.1. Analysis
Comparison 4 Dose comparison studies, Outcome 1 Proportion of patients with pain relief.
5.1
5.1. Analysis
Comparison 5 Toxicity, Outcome 1 Nausea and vomiting.
5.2
5.2. Analysis
Comparison 5 Toxicity, Outcome 2 Discontinuation of therapy.
6.1
6.1. Analysis
Comparison 6 Sensitivity analysis, Outcome 1 Route/type of bisphosphonate.Best response within 12 weeks (blinded studies only).
6.2
6.2. Analysis
Comparison 6 Sensitivity analysis, Outcome 2 Primary disease site.
6.3
6.3. Analysis
Comparison 6 Sensitivity analysis, Outcome 3 Study design (Blinded /open control) Pain relief using best response within 12 weeks.
6.4
6.4. Analysis
Comparison 6 Sensitivity analysis, Outcome 4 Pain as study entry criteria (Y/N) Pain relief using best response within 12 wks.
6.5
6.5. Analysis
Comparison 6 Sensitivity analysis, Outcome 5 Pain reporting (patient vs not specified) Pain relief using best response within 12 weeks.
6.6
6.6. Analysis
Comparison 6 Sensitivity analysis, Outcome 6 Blinded control, pain required, patient pain reporting, Pain relief using best response within 12 weeks.
6.7
6.7. Analysis
Comparison 6 Sensitivity analysis, Outcome 7 Quality of studies.
See this image and copyright information in PMC

References

References to studies included in this review

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Hortobagyi 1997 {published data only}
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Hortobagyi 1998 {published data only}
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Iddon 1998 {published data only}
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Iveson 1994 {published data only}
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Koberle 1997 {published data only}
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Kristensen 1999 {published data only}
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Kylmala 1993 {published data only}
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Laakso 1994 {published data only}
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LaCivita 1996 {published data only}
    1. LaCivita CL. Pain management for bone metastases. Am J Health Syst Pharm 1996;53:1907. - PubMed
Lipton 1994a {published data only}
    1. Lipton A, Glover D, Harvey H, Grabelsky S, Givant E, Lipton N. Disodium pamidronate (APD) ‐ a dose seeking study in patients with breast and prostate cancer: preliminary report (Meeting abstract). Osteoclast inhibition in the management of malignant related bone disorders. 1994; Vol. Bijvoet OL 7.
Lipton 1994b {published data only}
    1. Lipton A, Glover D, Harvey H, Grabelsky S, Zelenakas K, Macerata R, Seaman J. Pamidronate in the treatment of bone metastases: results of 2 dose‐ranging trials in patients with breast or prostate cancer. Annals of Oncology 1994;5(Suppl 7):S31‐5. - PubMed
Lipton 1997b {published data only}
    1. Lipton A, Theriault R, Leff R, Gluck S, Stewart J, Costello S. Long‐term reduction of skeletal complications in breast cancer patients with osteolytic bone metastases receiving hormone therapy, by monthly 90mg pamidronate (Aredia) infusions (Meeting abstract). Proc Annu Meet Am Soc Clin Oncol. 1997; Vol. 16:A531.
Lipton 1998a {published data only}
    1. Lipton A. Aredia: the once monthly infusion for the treatment of bone metastases. Current Opinion in Oncology 1998;10(Suppl 1):S1‐5. - PubMed
Lipton 1998b {published data only}
    1. Lipton A, Demers L, Curley E, Chinchilli V, Gaydos L, Hortobagyi G. Markers of bone resorption in patients treated with pamidronate. European Journal of Cancer 1998;34(13):2021‐6. - PubMed
Lipton 2000 {published data only}
    1. Lipton A, Theriault RL, Hortobagyi GN, Simeone J, Knight RD, Mellars K, et al. Pamidronate prevents skeletal complications and is effective palliative treatment in women with breast carcinoma and osteolytic bone metastases. Cancer 2000;88:1082‐90. - PubMed
Lortholary 1999 {published data only}
    1. Lortholary A, Jadaud E, Berthaud P. Bisphosphonates and bone metastases [Bisphosphonates et metastases osseuses]. Bulletin Cancer 1999;86(9):732‐8. - PubMed
Maolin 1998 {published data only}
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Maxon 1991 {published data only}
    1. Maxon HR 3rd, Schroder LE, Hertzberg VS, Thomas SR, Englaro EE, Samaratunga R, et al. Rhenium‐186(Sn)HEDP for treatment of painful osseous metastases: results of a double‐blind crossover comparison with placebo. Journal of Nuclear Medicine 1991;32(10):1877‐81. - PubMed
McCloskey 1998 {published data only}
    1. McCloskey EV, MacLennan IC, Drayson MT, Chapman C, Dunn J, Kanis JA. A randomized trial of the effect of clodronate on skeletal morbidity in multiple myeloma. MRC Working Party on Leukaemia in Adults. British Journal of Haematology 1998;100(2):317‐25. - PubMed
Mercadante 1997 {published data only}
    1. Mercadante S. Malignant bone pain: Pathophysiology and treatment. Pain 1997;69(1‐2):1‐18. - PubMed
Merlini 1990 {published data only}
    1. Merlini G, Parrinello GA, Piccinini L, Crema F, Fiorentini ML, Riccardi A, et al. Long‐term effects of parenteral dichloromethylene bisphosphonate (CL2MBP) on bone disease of myeloma patients treated with chemotherapy. Hematological Oncology 1990;8(1):23‐30. - PubMed
Mundy 1999 {published data only}
    1. Mundy GR. Bisphosphonates as cancer drugs. Hospital Practice (Office Edition) 1999;35(5):81‐4, 88‐9, 93‐4. - PubMed
Musto 1998 {published data only}
    1. Musto P. The role of bisphosphonates for the treatment of bone disease in multiple myeloma. Leukemia & Lymphoma 1998;31(5‐6):453‐62. - PubMed
Namer 1991 {published data only}
    1. Namer M. Clinical consequences of osteolytic bone metastases. Bone 1991;12(Suppl 1):S7. - PubMed
Paterson 1991b {published data only}
    1. Paterson AHG, Ernst DS, Powles TJ, Ashley S, McCloskey EV, Kanis JA. Treatment of skeletal disease in breast cancer with clodronate. Bone 1991;Suppl 1:S25‐30. - PubMed
Paterson 1993a {published data only}
    1. Paterson AH, Powles TJ, Kanis JA, McCloskey E, Hanson J, Ashley S. Double‐blind controlled trial of oral clodronate in patients with bone metastases from breast cancer. Journal of Clinical Oncology 1993;11(1):59‐65. - PubMed
Paterson 1993b {published data only}
    1. Paterson AH, Powles TJ, Kanis JA, McCloskey E, Hanson J, Ashley S. Double blind trial of oral clodronate in breast cancer patients with bone metastases [Essai en double aveugle du clodronate per os chez des patientes atteintes d'un cancer du sein avec metastases osseuses]. Bulletin du Cancer 1993;80(10 Suppl 6):50‐6. [MEDLINE: ] - PubMed
Paterson 1994 {published data only}
    1. Paterson AG, Goss G, Murphy K, Brennan JM. Quality of life measurement using the FLI‐C in breast cancer patients receiving single agent mitoxantrone (Meeting Abstract). International Association for Breast Cancer Research. 1994; Vol. April:25‐8.
Paterson 1997 {published data only}
    1. Paterson AH. Should bisphosphonates be standard therapy for bone pain?. Support Care Cancer 1997;5(3):200‐4. - PubMed
Paterson 1999 {published data only}
    1. Paterson AHG. The emerging role of bisphosphonates in the prevention of bone metastases. Trends in Endocrinology and Metabolism 1999;10(1):24‐9. - PubMed
Peest 1996 {published data only}
    1. Peest D, Deicher H, Fett W, Harms P, Braun HJ, Planker M, et al. Pyridinium cross‐links in multiple myeloma: correlation with clinical parameters and use of monitoring of intravenous clodronate therapy ‐ a pilot study of the German Myeloma Treatment Group (GMTG). European Journal of Cancer 1996;32A(12):2053‐7. - PubMed
Pelger 1998 {published data only}
    1. Pelger RC, Hamdy NA, Zwinderman AH, Lycklama a Nijeholt AA, Papapoulos SE. Effects of the bisphosphonate olpadronate in patients with carcinoma of the prostate metastatic to the skeleton. Bone 1998;22(4):403‐8. - PubMed
Plosker 1994 {published data only}
    1. Plosker GL, Goa KL. Clodronate. A review of its pharmacological properties and therapeutic efficacy in resorptive bone disease. Drugs 1994;47(6):945‐82. - PubMed
Powles 1991 {published data only}
    1. Powles T. Clodronate: the potential for the future. Bone. 1991; Vol. 12:S43‐44. - PubMed
Powles 1998 {published data only}
    1. Powles TJ, McCloskey E, Paterson AH, et al. Oral clodronate and reduction in loss of bone mineral density in women with operable primary breast cancer. Journal of the National Cancer Institute 1998;90(9):704‐8. - PubMed
Purohit 1994 {published data only}
    1. Purohit OP, Anthony C, Radstone CR, Owen J, Coleman RE. High‐dose intravenous pamidronate for metastatic bone pain. British Journal of Cancer 1994;70(3):554‐8. - PMC - PubMed
Radziwill 1993 {published data only}
    1. Radziwill AJ, Thurlimann B, Jungi WF. Improvement of palliation in patients with osteolytic bone disease and unsatisfactory pain control after pretreatment with disodium pamidronate: An intra‐patient dose escalation study. Onkologie 1993;16(3):174‐7.
Ravn 1996 {published data only}
    1. Ravn P, Clemmesen B, Riis BJ, Christiansen C. The effect on bone mass and bone markers of different doses of ibandronate: A new bisphosphonate for prevention and treatment of postmenopausal osteoporosis: A 1‐year, randomized, double‐blind, placebo‐controlled dose‐finding study. Bone 1996;19(5):527‐33. - PubMed
Riccardi 1994 {published data only}
    1. Riccardi A, Ucci G, Brugnatelli S, et al. Prospective, controlled, non‐randomized study on prophylactic parenteral dichloromethylene bisphosphonate (clodronate) in multiple myeloma. International Journal of Oncology 1994;5(4):833‐9. - PubMed
Ripamonti 1998 {published data only}
    1. Ripamonti C, Fulfaro F, Ticozzi C, Casuccio A, Conno F. Role of pamidronate disodium in the treatment of metastatic bone disease. Tumori 1998;84(4):442‐55. - PubMed
Rose 1992 {published data only}
    1. Rose C, Ford J, Becher R, Possinger K, Coleman R, Rubens RD. Pamidronate disodium (Aredia) dose effect and tolerability evaluation in breast cancer patients with bone metastases (Meeting abstract). Annals of Oncology. 1992; Vol. 3:5.
Rotstein 1992 {published data only}
    1. Rotstein S, Glas U, Eriksson M, Pfeiffer P, Hansen J, Soderqvist J. Intravenous clodronate for the treatment of hypercalcemia in breast cancer patients with bone metastases: a prospective randomized placebo‐ controlled multicenter study. European Journal of Cancer 1992;28A:890‐3. - PubMed
Ryzen 1985 {published data only}
    1. Ryzen E, Rude RK, Elbaum N, Singer FR. Use of intravenous etidronate disodium in the treatment of hypercalcemia. In: Garattini S editor(s). Bone resorption, metastasis and diphosphonates. Monographs of athe Mario Negri Institute for Pharmacological Research. New York: Raven Press, 1985:99‐108. [86626524]
Shucai 1999 {published data only}
    1. Shucai Z, Guimei L, Fanbin H. A clinical trial of Bonin in bone metastases of lung cancer [Chinese]. Chinese Journal of Clinical Oncology 1999;26(6):445‐7.
Siris 1983b {published data only}
    1. Siris ES, Sherman WH, Baquiran DC, Schlatterer JP, Osserman EF, Canfield RE. Effect of dicholoromethylene diphosphonate on skeletal mobilization of calcium in multiple myeloma. New England Journal of Medicine 1980;302:310‐5. - PubMed
Strang 1996 {published data only}
    1. Strang P. Analgesic effect of bisphosphonates on bone pain in breast cancer patients. A review article. Acta Oncologica. 1996; Vol. 35, issue 5:50‐4. - PubMed
Taube 1994 {published data only}
    1. Taube T, Kylmala T, Lamberg Allardt C, Tammela TLJ, Elomaa I. The effect of clodronate on bone in metastatic prostate cancer. Histomorphometric report of a double‐blind randomised placebo‐controlled study. European Journal of Cancer 1994;30(6):751‐8. - PubMed
Theriault 1996a {published data only}
    1. Theriault R. Pamidronate in the treatment of osteolytic bone metastases in breast cancer patients. Br J Clin Pract Suppl 1996;87:8‐12 (discussion 13‐4). - PubMed
Theriault 1996b {published data only}
    1. Theriault R, Lipton A, Leff R, Gluck S, Stewart J, Costello S. Reduction of skeletal related complications in breast cancer patients with osteolytic bone metastases receiving hormone therapy, by monthly pamidronate sodium (Aredia) infusion (Meeting abstract). Proc Annu Meet Am Soc Clin Oncol. 1996; Vol. 15:A152.
Thurlimann 1994a {published data only}
    1. Thurlimann B. Progress in the treatment and palliation of advanced breast cancer: does the dose of pamidronate determine its effects?. Ann Oncol. 1994; Vol. 5 Suppl 7:S45‐7. - PubMed
Thurlimann 1994b {published data only}
    1. Thurlimann B, Morant R, Jungi WF, Radziwill A. Pamidronate for pain control in patients with malignant osteolytic bone disease: a prospective dose‐effect study. Support Care Cancer 1994;2(1):61‐5. - PubMed
Tubiana‐Hulin 1995 {published data only}
    1. Tubiana‐Hulin M, Beuzeboc P, Mauriac L, Barbet N, Frenay M, Monnier A. Double blind placebo controlled trial of oral clodronate in patients with bone metastases from breast cancer: effects on induced hyperosteolysis (Meeting abstract). Proc Annu Meet Am Soc Clin Oncol. 1995; Vol. 14:A1718.
Tyrrell 1994 {published data only}
    1. Tyrrell CJ, Bruning PF, May Levin F, et al. Role of pamidronate in the management of bone metastases from breast cancer: Results of a non‐comparative multicenter phase II trial. Annals of Oncology 1994;5(Suppl 7):37‐40. - PubMed
Tyrrell 1995 {published data only}
    1. Tyrrell CT, Bruning PF, May Levin F, et al. Pamidronate infusions as single‐agent therapy for bone metastases: A phase II trial in patients with breast cancer. European Journal of Cancer 1995;31(12):1976‐80. - PubMed
van Holten 1991 {published data only}
    1. Holten Verzantvoort ATM, Zwinderman AH, Aaronson NK, et al. The effect of supportive pamidronate treatment on aspects of quality of life of patients with advanced breast cancer. European Journal of Cancer 1991;27(5):544‐9. - PubMed
van Holten 1994 {published data only}
    1. Holten‐Verzantvoort AT, Cleton FJ, Hermans J, Zwinderman AH, Bijvoet OL. Long‐term bisphosphonate treatment of bone metastases in breast cancer patients? (Meeting abstract). European Journal of Cancer 1996.
van Holten 1996b {published data only}
    1. Holten‐Verzantvoort AT, Hermans J, Beex LV, Blijham G, Cleton FJ, Eck‐Smit BC. Does supportive pamidronate treatment prevent or delay the first manifestation of bone metastases in breast cancer patients?. European Journal of Cancer 1996;32A:450‐454. - PubMed
Vinholes 1996a {published data only}
    1. Vinholes J, Guo CY, Purohit OP, Eastell R, Coleman RE. Metabolic effects of pamidronate in patients with metastatic bone disease. Br J Cancer 1996;73:1089‐95. - PMC - PubMed
Vinholes 1996b {published data only}
    1. Vinholes J, Purohit OP, Eastell R, Coleman RE. Evaluation of new bone resorption markers in a randomised trial of pamidronate for metastatic bone pain (Abstract). Br J Cancer. 1996; Vol. 73:16.
Vinholes 1997b {published data only}
    1. VinholesJ, Guo CY, Purohit OP, et al. Evaluation of new bone resoption markers in a randomised comparison of pamidronate or clodronate for hypercalcaemia of malignancy. Journal of Clinical Oncology 1997;15(1):131‐8. - PubMed
Vorreuther 1993 {published data only}
    1. Vorreuther R. Biphosphonates as an adjunct to palliative therapy of bone metastases from prostatic carcinoma. A pilot study on clodronate. Br J Urol 1993;72(5):792‐5. - PubMed
Walker 1997 {published data only}
    1. Walker P, Watanabe S, Lawlor P, et al. Subcutaneous clodronate: a study evaluating efficacy in hypercalcaemia of malignancy and local toxicity. Annals of Oncology 1997;8(9):915‐6. - PubMed

References to studies awaiting assessment

Berenson 2000 {published data only}
    1. Berenson J, Rosen L, Howell A, Porter L, Coleman R, Morley W, et al. Zoledronic acide reduces skeletal related events in patients with oseolytic metastases: a double‐blind, randomized dose response study. Breast Cancer Res Treat 2000;64:32. [CGP‐42, 446 (1423) 125E]
    1. Berenson JR, Rosen LS, Howell A, Porter L, Coleman RE, Morley W, et al. Zoledronic acid reduces skeletal‐related events in patients with osteolytic metastases. Cancer 2001;91:1191‐200. - PubMed
Kraj 2000a {published data only}
    1. Kraj M, Poglod R, Pawlikowsky J, Maj S. The effect of long‐term pamidronate treatment on skeletal morbidity in advanced multiple myeloma. Acta Haematologica Palonica 2000;31:379‐89.
Kraj 2000b {published data only}
    1. Kraj M, Poglod R, Pawlikowsky J, Maj S. Effect of pamidronate on skeletal morbidity in myelomatosis. Part I: The results of the 12 months of pamidronate therapy. Acta Poloniae Pharmaceutica 2000;57 (suppl):113‐16. - PubMed
Major 2001 {published data only}
    1. Major P, Lortholary A, Jon J, Abdi E, Mills G, Menssen HD, et al. Zoledronic acid is superior to pamidronate in the treatment of hypercalcemia of malignancy: a pooled analysis of two randomized, controlled clinical trials. J Clin Oncol 2001;19:558‐67. - PubMed
McCloskey 2001 {published data only}
    1. McCloskey EV, Dunn JA, Kanis JA, MacKennan ICM, Drayson MT on behalf of the Medical Research Council Working Party on Leukemia in Adults. Long‐term follow‐up of a prospective, double‐blind, placebo‐controlled randomized trial of clodronate in multiple myeloma. British Journal of Haematology 2001;113:1035‐43. - PubMed
Terpos 2000 {published data only}
    1. Terpos E, Palermos J, Tsionos K, Anargyrou K, Viniou N, Papassavas P, Meletis J, Yataganas X. Effect of pamidronate administration on markers of bone turnover and disease activity in multiple myeloma. Eur J Haematol 2000;65:331‐6. - PubMed

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