Biochemical and radiologic improvement in Paget's disease of bone treated with alendronate: A randomized, placebo-controlled trial

Reid, Ian R., Nicholson, Geoffrey C., Weinstein, Robert S., Hosking, David J., Cundy, Tim, Kotowicz, Mark A., Murphy, William A., Yeap, Swan, Dufresne, Suzanne, Lombardi, Antonio, Musliner, Thomas A., Thompson, Desmond E. and Yates, A. John (1996) Biochemical and radiologic improvement in Paget's disease of bone treated with alendronate: A randomized, placebo-controlled trial. American Journal of Medicine, 101 4: 341-348. doi:10.1016/S0002-9343(96)00227-6


Author Reid, Ian R.
Nicholson, Geoffrey C.
Weinstein, Robert S.
Hosking, David J.
Cundy, Tim
Kotowicz, Mark A.
Murphy, William A.
Yeap, Swan
Dufresne, Suzanne
Lombardi, Antonio
Musliner, Thomas A.
Thompson, Desmond E.
Yates, A. John
Title Biochemical and radiologic improvement in Paget's disease of bone treated with alendronate: A randomized, placebo-controlled trial
Journal name American Journal of Medicine   Check publisher's open access policy
ISSN 0002-9343
1555-7162
Publication date 1996-10
Sub-type Article (original research)
DOI 10.1016/S0002-9343(96)00227-6
Volume 101
Issue 4
Start page 341
End page 348
Total pages 8
Place of publication Bridgewater, NJ, United States
Publisher Excerpta Medica
Language eng
Formatted abstract
Purpose
The potent bisphosphonates offer great promise in the management of Paget's disease of bone, but are currently available only as parenteral preparations in most countries. There is a need for a well-tolerated, oral therapy. Furthermore, none of the currently available therapies have been rigorously demonstrated to heal the lytic bone lesions characteristic of this condition. Alendronate is a potent new oral aminobisphosphonate that has shown promising effects on Paget's disease in preliminary studies.

Methods

We report a double-blind, randomized comparison of oral alendronate 40 mg/day and placebo over 6 months in 55 patients with Pagef s disease. Efficacy was determined from measurements of biochemical indices of bone turnover (serum alkaline phosphatase and urine N-telopeptide) and blinded radiologic assessment of lytic bone lesions.

Results

N-telopeptide excretion declined by 86% and serum alkaline phosphatase by 73% in patients receiving alendronate, but remained stable in patients receiving placebo (P < 0.001 between groups for both indices). Responses were similar whether or not patients had previously received bisphosphonate treatment. Alendronate treatment normalized alkaline phosphatase in 48% of patients. Forty-eight percent of alendronate-treated patients showed radiologic improvement in osteolysis whereas in the placebo group only 4% improved (P = 0.02 for between-groups comparison). No patient in either group showed worsening of osteolysis. Bone histomorphometry indicated that alendronate tended to normalize turnover indices. There was no evidence of abnormal mineralization in bone biopsies taken from 12 alendronate-treated subjects. The treatment was well tolerated.

Conclusion

Oral alendronate appears to be a safe and effective therapy for Paget's disease and results in healing of lytic bone lesions.
Keyword APD
Histomorphometry
Bisphosphonate
Responses
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status Non-UQ

Document type: Journal Article
Sub-type: Article (original research)
Collection: School of Medicine Publications
 
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