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.
| uNTX/Cr | sP1NP | Lumbar Spine BMD | Total Hip BMD | |
| Continued Alendronate 70 mg weekly | 2.3 (−9.2, 15.3) | −5.5 (−16.7, 7.3) | 1.5 (0.3, 2.6) | 0.4 (−0.4, 1.3) |
| Switch to Placebo | 66.3 (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 | <0.0001 | 0.0137 | 0.0002 |
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