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Bone Abstracts (2013) 1 PP448 | DOI: 10.1530/boneabs.1.PP448

ECTS2013 Poster Presentations Osteoporosis: treatment (64 abstracts)

Resolution of effects on bone turnover markers and bone mineral density after discontinuation of long-term bisphosphonate use

Claude Benhamou 1 , Tobias De Villiers 2 , C Conrad Johnston 3 , Bente Langdahl 4 , Kenneth Saag 5 , Andrew Denker 6 , Annpey Pong 6 , John P McGinnis 6 , Elizabeth Rosenberg 6 & Arthur Santora 6


1Hopital d’Orleans la Source, Orleans, France; 2Mediclinic Panorama, Western Cape, South Africa; 3Indiana University School of Medicine, Indianapolis, Indiana, USA; 4Aarhus University Hospital, Aarhus, Denmark; 5University of Alabama, Birmingham, Alabama, USA; 6Merck Sharp and Dohme Corp., Whitehouse Station, New Jersey, USA.


Relatively little is known about immediate consequences of continuing vs interrupting long-term bisphosphonate treatment. This report describes changes in bone turnover and BMD in a 1-year, dose-finding trial of the calcium-sensing receptor antagonist MK-5442 in postmenopausal, BP-treated women, randomized to continued alendronate 70 mg weekly, switch to placebo, or switch to MK-5442. Recruited women (n=526) had taken alendronate for ≥12 months and an oral BP for ≥3 of the 4 years preceding the trial, with spine or hip BMD T-scores ≤−2.5 (or ≤−1.5 with prior fragility fracture) and ≧−4.0. Statistical tests of within-group changes and comparison between placebo and alendronate were performed post-hoc. At baseline, women continued on alendronate (n=87) or switched to placebo (n=88) were of mean age 67 years with mean baseline T-scores at lumbar spine −2.5 and total hip −1.6, urine NTX/Cr=26.6 nmol BCE/mmol Cr, serum P1NP=26.0 ng/ml, and median length of previous BP use 5.2 years. After 1 month, women switched to placebo experienced increases from baseline in NTX/Cr (28.4% vs continued alendronate, P<0.0001). Both NTX/Cr and P1NP increased by 3 months (33.7 and 37.8% vs alendronate, both P<0.0001). After 12 months of placebo, mean concentrations of NTX/Cr and P1NP rose to 42.2 nmol BCE/mmol Cr and 40.1 ng/ml, both markers unchanged with continued ALN (Table). After 12 months, there were also significant treatment-differences in BMD (Table). In conclusion, discontinuation of bisphosphonate treatment after a median of 5 years resulted in increases in NTX/Cr by 1 month and P1NP by 3 months. After 1 year, both markers returned to levels similar to those expected in untreated postmenopausal women, and spine and hip BMD were reduced vs continued treatment with alendronate.

Table 1 12 Month Least Squares Mean % Change from Baseline (95% CI).
uNTX/CrsP1NPLumbar Spine BMDTotal Hip BMD
Continued Alendronate 70 mg weekly2.3 (−9.2, 15.3)−5.5 (−16.7, 7.3)1.5 (0.3, 2.6)0.4 (−0.4, 1.3)
Switch to Placebo66.3 (47.3, 87.7)69.2 (48.6, 92.6)−0.2 (−1.3, 0.8)−1.4 (−2.2, −0.6)
P-value between groups<0.0001<0.00010.01370.0002

Volume 1

European Calcified Tissue Society Congress 2013

Lisbon, Portugal
18 May 2013 - 22 May 2013

European Calcified Tissue Society 

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