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A randomized clinical trial comparing oral alendronate and intravenous pamidronate for the treatment of Paget's disease of bone.
Bone. 2004 Apr; 34(4):747-54.BONE

Abstract

Second and third generation bisphosphonates are the treatment of choice for Paget's disease of bone. These drugs are more effective than calcitonin and etidronate, but there have been no head to head, randomized controlled trials comparing potent bisphosphonates. We conducted a 2-year, randomized, open-label trial comparing oral alendronate and intravenous pamidronate in 72 subjects with Paget's disease. Randomization was stratified according to baseline plasma total alkaline phosphatase (ALP) and previous bisphosphonate treatment (yes or no). All previously treated patients had received pamidronate but not alendronate. Assigned treatments were pamidronate (60 mg) every 3 months as a single infusion or alendronate (40 mg) daily in 3-month blocks, continued until biochemical remission (defined as both ALP and urine deoxypyridinoline (DPD)/creatinine ratio in the reference range) or a clear plateau effect was observed. At 1 year, nonresponders to pamidronate were crossed over to alendronate treatment. At 1 year, 31/36 (86%) subjects randomized to alendronate achieved biochemical remission compared with 21/36 (56%) for pamidronate (P = 0.017). There was a significantly greater reduction in ALP (P < 0.001) and DPD/creatinine ratio (P < 0.001) for alendronate compared with pamidronate treatment. In previously untreated patients, alendronate resulted in remission in 20/22 (91%) subjects compared with 19/22 (86%) of pamidronate-treated subjects, which was not significantly different; however, alendronate resulted in a significantly greater reduction in ALP (P = 0.014) and DPD/creatinine ratio (P < 0.001). In previously treated patients, alendronate resulted in remission in 11/14 (79%) subjects compared with 2/14 (14%) for pamidronate (P < 0.001), with a significantly (P < 0.001) greater reduction in both ALP and DPD/creatinine ratio. Of subjects crossed over from pamidronate to alendronate, 10/14 (71%) achieved remission, including 9/11 (82%) previously treated patients. We conclude that, in patients with previously untreated Paget's disease of bone, alendronate and pamidronate have similar efficacy in achieving biochemical remission. In patients previously treated with pamidronate, alendronate is more effective.

Authors+Show Affiliations

Department of Endocrinology and Diabetes, Sir Charles Gairdner Hospital, Nedlands, WA 6009, Australia. john.walsh@health.wa.gov.auNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

15050907

Citation

Walsh, J P., et al. "A Randomized Clinical Trial Comparing Oral Alendronate and Intravenous Pamidronate for the Treatment of Paget's Disease of Bone." Bone, vol. 34, no. 4, 2004, pp. 747-54.
Walsh JP, Ward LC, Stewart GO, et al. A randomized clinical trial comparing oral alendronate and intravenous pamidronate for the treatment of Paget's disease of bone. Bone. 2004;34(4):747-54.
Walsh, J. P., Ward, L. C., Stewart, G. O., Will, R. K., Criddle, R. A., Prince, R. L., Stuckey, B. G., Dhaliwal, S. S., Bhagat, C. I., Retallack, R. W., Kent, G. N., Drury, P. J., Vasikaran, S., & Gutteridge, D. H. (2004). A randomized clinical trial comparing oral alendronate and intravenous pamidronate for the treatment of Paget's disease of bone. Bone, 34(4), 747-54.
Walsh JP, et al. A Randomized Clinical Trial Comparing Oral Alendronate and Intravenous Pamidronate for the Treatment of Paget's Disease of Bone. Bone. 2004;34(4):747-54. PubMed PMID: 15050907.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized clinical trial comparing oral alendronate and intravenous pamidronate for the treatment of Paget's disease of bone. AU - Walsh,J P, AU - Ward,L C, AU - Stewart,G O, AU - Will,R K, AU - Criddle,R A, AU - Prince,R L, AU - Stuckey,B G A, AU - Dhaliwal,S S, AU - Bhagat,C I, AU - Retallack,R W, AU - Kent,G N, AU - Drury,P J, AU - Vasikaran,S, AU - Gutteridge,D H, PY - 2003/10/24/received PY - 2003/12/05/revised PY - 2003/12/12/accepted PY - 2004/3/31/pubmed PY - 2004/12/23/medline PY - 2004/3/31/entrez SP - 747 EP - 54 JF - Bone JO - Bone VL - 34 IS - 4 N2 - Second and third generation bisphosphonates are the treatment of choice for Paget's disease of bone. These drugs are more effective than calcitonin and etidronate, but there have been no head to head, randomized controlled trials comparing potent bisphosphonates. We conducted a 2-year, randomized, open-label trial comparing oral alendronate and intravenous pamidronate in 72 subjects with Paget's disease. Randomization was stratified according to baseline plasma total alkaline phosphatase (ALP) and previous bisphosphonate treatment (yes or no). All previously treated patients had received pamidronate but not alendronate. Assigned treatments were pamidronate (60 mg) every 3 months as a single infusion or alendronate (40 mg) daily in 3-month blocks, continued until biochemical remission (defined as both ALP and urine deoxypyridinoline (DPD)/creatinine ratio in the reference range) or a clear plateau effect was observed. At 1 year, nonresponders to pamidronate were crossed over to alendronate treatment. At 1 year, 31/36 (86%) subjects randomized to alendronate achieved biochemical remission compared with 21/36 (56%) for pamidronate (P = 0.017). There was a significantly greater reduction in ALP (P < 0.001) and DPD/creatinine ratio (P < 0.001) for alendronate compared with pamidronate treatment. In previously untreated patients, alendronate resulted in remission in 20/22 (91%) subjects compared with 19/22 (86%) of pamidronate-treated subjects, which was not significantly different; however, alendronate resulted in a significantly greater reduction in ALP (P = 0.014) and DPD/creatinine ratio (P < 0.001). In previously treated patients, alendronate resulted in remission in 11/14 (79%) subjects compared with 2/14 (14%) for pamidronate (P < 0.001), with a significantly (P < 0.001) greater reduction in both ALP and DPD/creatinine ratio. Of subjects crossed over from pamidronate to alendronate, 10/14 (71%) achieved remission, including 9/11 (82%) previously treated patients. We conclude that, in patients with previously untreated Paget's disease of bone, alendronate and pamidronate have similar efficacy in achieving biochemical remission. In patients previously treated with pamidronate, alendronate is more effective. SN - 8756-3282 UR - https://www.unboundmedicine.com/medline/citation/15050907/A_randomized_clinical_trial_comparing_oral_alendronate_and_intravenous_pamidronate_for_the_treatment_of_Paget's_disease_of_bone_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S8756328203004721 DB - PRIME DP - Unbound Medicine ER -