title: Once-weekly teriparatide in hemodialysis patients with hypoparathyroidism and low bone mass: a prospective study.
abstract: 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.
  
  
  BACKGROUND
  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.
authors.affiliation: Nephrology Center, Toranomon Hospital Kajigaya, 1-3-1, Kajigaya, Takatsu-ku, Kawasaki, Kanagawa, 213-8587, Japan. k-sumida@umin.ac.jp.|Nephrology Center, Toranomon Hospital, Tokyo, Japan. k-sumida@umin.ac.jp.|Okinaka Memorial Institute for Medical Research, Tokyo, Japan. k-sumida@umin.ac.jp.
authors.forename: K
authors.initials: K
authors.lastname: Sumida
authors.affiliation: Nephrology Center, Toranomon Hospital Kajigaya, 1-3-1, Kajigaya, Takatsu-ku, Kawasaki, Kanagawa, 213-8587, Japan.|Nephrology Center, Toranomon Hospital, Tokyo, Japan.|Okinaka Memorial Institute for Medical Research, Tokyo, Japan.
authors.forename: Y
authors.initials: Y
authors.lastname: Ubara
authors.affiliation: Nephrology Center, Toranomon Hospital Kajigaya, 1-3-1, Kajigaya, Takatsu-ku, Kawasaki, Kanagawa, 213-8587, Japan.|Nephrology Center, Toranomon Hospital, Tokyo, Japan.
authors.forename: J
authors.initials: J
authors.lastname: Hoshino
authors.affiliation: Nephrology Center, Toranomon Hospital Kajigaya, 1-3-1, Kajigaya, Takatsu-ku, Kawasaki, Kanagawa, 213-8587, Japan.
authors.forename: K
authors.initials: K
authors.lastname: Mise
authors.affiliation: Nephrology Center, Toranomon Hospital Kajigaya, 1-3-1, Kajigaya, Takatsu-ku, Kawasaki, Kanagawa, 213-8587, Japan.|Nephrology Center, Toranomon Hospital, Tokyo, Japan.
authors.forename: N
authors.initials: N
authors.lastname: Hayami
authors.affiliation: Nephrology Center, Toranomon Hospital Kajigaya, 1-3-1, Kajigaya, Takatsu-ku, Kawasaki, Kanagawa, 213-8587, Japan.|Nephrology Center, Toranomon Hospital, Tokyo, Japan.
authors.forename: T
authors.initials: T
authors.lastname: Suwabe
authors.affiliation: Nephrology Center, Toranomon Hospital, Tokyo, Japan.
authors.forename: M
authors.initials: M
authors.lastname: Kawada
authors.affiliation: Nephrology Center, Toranomon Hospital, Tokyo, Japan.
authors.forename: A
authors.initials: A
authors.lastname: Imafuku
authors.affiliation: Nephrology Center, Toranomon Hospital, Tokyo, Japan.
authors.forename: R
authors.initials: R
authors.lastname: Hiramatsu
authors.affiliation: Nephrology Center, Toranomon Hospital, Tokyo, Japan.
authors.forename: E
authors.initials: E
authors.lastname: Hasegawa
authors.affiliation: Nephrology Center, Toranomon Hospital, Tokyo, Japan.
authors.forename: M
authors.initials: M
authors.lastname: Yamanouchi
authors.affiliation: Nephrology Center, Toranomon Hospital, Tokyo, Japan.
authors.forename: N
authors.initials: N
authors.lastname: Sawa
authors.affiliation: Nephrology Center, Toranomon Hospital Kajigaya, 1-3-1, Kajigaya, Takatsu-ku, Kawasaki, Kanagawa, 213-8587, Japan.|Nephrology Center, Toranomon Hospital, Tokyo, Japan.|Okinaka Memorial Institute for Medical Research, Tokyo, Japan.
authors.forename: K
authors.initials: K
authors.lastname: Takaichi
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D015519:Bone Density / Q000187:drug effects; D050071:Bone Density Conservation Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D004334:Drug Administration Schedule; D005260:Female; D005272:Femur Neck / Q000503:physiopathology; D006801:Humans; D007011:Hypoparathyroidism / Q000150:complications* / Q000503:physiopathology; D007676:Kidney Failure, Chronic / Q000150:complications* / Q000503:physiopathology / Q000628:therapy; D008159:Lumbar Vertebrae / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D010024:Osteoporosis / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D011446:Prospective Studies; D011884:Radius / Q000503:physiopathology; D006435:Renal Dialysis; D019379:Teriparatide / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use
chemical_list: D050071:Bone Density Conservation Agents; D019379:Teriparatide
keywords: Hemodialysis; Hypoparathyroidism; Low-turnover bone disease; Teriparatide