Once-weekly teriparatide in hemodialysis patients with hypoparathyroidism and low bone mass: a prospective study

Summary Once-weekly 56.5-μg teriparatide treatment was significantly associated with the increase in lumbar spine bone mineral density at 48 weeks among hemodialysis patients with hypoparathyroidism and low bone mass; however, discontinuation of treatment because of adverse events was frequently obs...

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Bibliographic Details
Published in:Osteoporosis international 2016-04, Vol.27 (4), p.1441-1450
Main Authors: Sumida, K., Ubara, Y., Hoshino, J., Mise, K., Hayami, N., Suwabe, T., Kawada, M., Imafuku, A., Hiramatsu, R., Hasegawa, E., Yamanouchi, M., Sawa, N., Takaichi, K.
Format: Article
Language:English
Subjects:
Aged
Aged, 80 and over
Bone Density - drug effects
Bone Density Conservation Agents - administration & dosage
Bone Density Conservation Agents - adverse effects
Bone Density Conservation Agents - therapeutic use
Bone diseases
Drug Administration Schedule
Drug therapy
Endocrine system
Endocrinology
Female
Femur Neck - physiopathology
Hemodialysis
Humans
Hypoparathyroidism - complications
Hypoparathyroidism - physiopathology
Kidney Failure, Chronic - complications
Kidney Failure, Chronic - physiopathology
Kidney Failure, Chronic - therapy
Lumbar Vertebrae - physiopathology
Male
Medicine
Medicine & Public Health
Middle Aged
Original Article
Orthopedics
Osteoporosis - drug therapy
Osteoporosis - etiology
Osteoporosis - physiopathology
Prospective Studies
Radius - physiopathology
Renal Dialysis
Rheumatology
Teriparatide - administration & dosage
Teriparatide - adverse effects
Teriparatide - therapeutic use
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Summary:Summary Once-weekly 56.5-μg teriparatide treatment was significantly associated with the increase in lumbar spine bone mineral density at 48 weeks among hemodialysis patients with hypoparathyroidism and low bone mass; however, discontinuation of treatment because of adverse events was frequently observed. Careful monitoring for adverse events should be required. Introduction Once-weekly 56.5-μg teriparatide is reportedly effective for treating osteoporotic patients without renal insufficiency. However, little is known about the efficacy and safety of once-weekly teriparatide in hemodialysis patients. Methods We conducted a 48-week prospective, observational cohort study including 22 hemodialysis patients aged 20 years or older with hypoparathyroidism and low bone mass who received once-weekly teriparatide at 56.5 μg at a tertiary care hospital between January 2013 and January 2015. Primary outcomes were within-subject percent changes of bone mineral density (BMD) at the lumbar spine, femoral neck, and distal one-third radius at 24 and 48 weeks. Secondary outcomes included percent changes of serum bone turnover markers (osteocalcin, bone-specific alkaline phosphatase (BAP), N-terminal propeptide of procollagen type 1 (P1NP), and tartrate-resistant acid phosphatase 5b (TRAP-5b)). Adverse events were evaluated. Results The BMD increased at the lumbar spine by 3.3 ± 1.9 % (mean ± SEM) and 3.0 ± 1.8 % at 24 and 48 weeks but not in the femoral neck and distal one-third radius. Serum osteocalcin, BAP, and P1NP increased significantly at 4 weeks, maintaining higher concentrations up to 48 weeks, although TRAP-5b decreased gradually during treatment. The baseline BAP was significantly associated with the 48-week percent change in lumbar spine BMD. Transient hypotension was the most common adverse event. Ten patients discontinued treatment because of adverse events. Conclusions Once-weekly teriparatide was associated with increased lumbar spine BMD in hemodialysis patients with hypoparathyroidism and low bone mass. Careful monitoring should be required for treatment of such patients.
ISSN:0937-941X
1433-2965
DOI:10.1007/s00198-015-3377-6