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J Clin Endocrinol Metab. 2019 Oct 26. pii: dgz095. doi: 10.1210/clinem/dgz095. [Epub ahead of print]

Bone Mineral Density After Transitioning From Denosumab to Alendronate.

Author information

1
University of British Columbia, Vancouver, BC, Canada.
2
Amgen Inc., Thousand Oaks, CA, USA.
3
Hospital Infantil de Mexico Federico Gómez and National University of Mexico-UNAM, Mexico City, Mexico.
4
Monash University, Melbourne, VIC, Australia.
5
Oregon Osteoporosis Center, Portland, OR, USA.
6
Australian Catholic University, Melbourne, VIC, Australia.
7
Yonsei University College of Medicine, Seoul, South Korea.
8
Amgen Inc., Zug, Switzerland.

Abstract

CONTEXT:

There are few studies on subjects transitioning from denosumab to bisphosphonates.

OBJECTIVE:

To investigate subject characteristics and changes in bone mineral density (BMD) after transitioning from denosumab to alendronate.

DESIGN:

Randomized, open-label, 2-year crossover Denosumab Adherence Preference Satisfaction (DAPS) study (NCT00518531).

SETTING:

25 study centers in the USA and Canada.

PATIENTS:

Treatment-naïve postmenopausal women with BMD T-scores ≤-2.0 to ≥-4.0.

INTERVENTIONS:

This post hoc analysis evaluated subjects randomized to denosumab 60 mg SC Q6M in year 1 followed by alendronate 70 mg QW PO in year 2.

MAIN OUTCOME MEASURE:

A 3% BMD threshold identified subjects who lost, maintained, or gained BMD in year 2 on alendronate.

RESULTS:

Of 126 subjects randomized to denosumab, 115 (91%) transitioned to alendronate in year 2. BMD increased by 3%-6% with denosumab in year 1 and by 0%-1% with alendronate in year 2. After transitioning to alendronate, most subjects maintained or increased BMD; 15.9%, 7.6%, and 21.7% lost BMD at the lumbar spine, total hip, and femoral neck, respectively. Few subjects fell below their pretreatment baseline BMD value; this occurred most often in those who lost BMD in year 2. Subjects who lost BMD with alendronate in year 2 also showed a greater percent change in BMD with denosumab in year 1. The BMD change in year 2 was similar regardless of baseline characteristics or adherence to oral alendronate.

CONCLUSION:

Alendronate can effectively maintain the BMD gains accrued after 1 year of denosumab in most subjects, regardless of baseline characteristics.

KEYWORDS:

alendronate; bisphosphonates; bone mineral density; denosumab; osteoporosis

PMID:
31665314
DOI:
10.1210/clinem/dgz095

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