PMID- 26684150
OWN - NLM
STAT- MEDLINE
DCOM- 20160808
LR  - 20210204
IS  - 1530-891X (Print)
IS  - 1530-891X (Linking)
VI  - 22
IP  - 5
DP  - 2016 May
TI  - AN OPEN-LABEL EXTENSION STUDY OF PARATHYROID HORMONE RHPTH(1-84) IN ADULTS WITH 
      HYPOPARATHYROIDISM.
PG  - 523-32
LID - 10.4158/EP15936.OR [doi]
AB  - OBJECTIVE: Hypoparathyroidism is characterized by inadequate parathyroid hormone 
      (PTH), resulting in hypocalcemia, hyperphosphatemia, and bone abnormalities. 
      Adults with hypoparathyroidism treated with recombinant human PTH, rhPTH(1-84), 
      in the 24-week, phase III REPLACE study maintained serum calcium despite 
      reductions in oral calcium and active vitamin D. This study assessed the 
      long-term efficacy and safety of rhPTH(1-84) for hypoparathyroidism. METHODS: 
      This was a 24-week, open-label, flexible-dose extension study of REPLACE (REPEAT) 
      conducted in 3 outpatient centers in Hungary. Patients who previously completed 
      or enrolled in REPLACE received 50 mug/day rhPTH(1-84), escalated to 75 and then 
      to 100 mug/day, if needed, to reduce active vitamin D and oral calcium. The 
      primary endpoint was >/=50% reduction in oral calcium (or </=500 mg/day) and active 
      vitamin D (or calcitriol </=0.25 mug/day or alfacalcidol </=0.50 mug/day) with 
      normocalcemia. RESULTS: Twenty-four patients (n = 16 previously treated with 
      rhPTH[1-84]; n = 8 rhPTH[1-84]-naive) were enrolled and completed the study. At 
      Week 24, 75% of patients (95% confidence interval [CI], 53.3-90.2%) achieved the 
      study endpoint; 58% eliminated oral calcium and active vitamin D. Urinary 
      calcium, serum phosphate, and calcium x phosphate (Ca x P) product decreased by 
      Week 24. Mean serum bone turnover markers increased with rhPTH(1-84). 
      Treatment-emergent adverse events (TEAEs) were reported by 92% of patients. No 
      serious adverse events (AEs) occurred. CONCLUSION: This study used a simplified 
      treatment algorithm intended to better mimic typical clinical practice and 
      demonstrated the extended efficacy and safety of rhPTH(1-84) in patients with 
      hypoparathyroidism and confirmed the REPLACE findings. Sustained rhPTH(1-84) 
      efficacy up to 48 weeks was observed despite treatment interruption between 
      studies.
FAU - Lakatos, Peter
AU  - Lakatos P
FAU - Bajnok, Laszlo
AU  - Bajnok L
FAU - Lagast, Hjalmar
AU  - Lagast H
FAU - Valkusz, Zsuzsanna
AU  - Valkusz Z
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20151218
PL  - United States
TA  - Endocr Pract
JT  - Endocrine practice : official journal of the American College of Endocrinology 
      and the American Association of Clinical Endocrinologists
JID - 9607439
RN  - 0 (PTH protein, human)
RN  - 0 (Parathyroid Hormone)
RN  - 0 (Recombinant Proteins)
RN  - SY7Q814VUP (Calcium)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Bone Density/drug effects
MH  - Calcium/blood/urine
MH  - Female
MH  - Humans
MH  - Hungary/epidemiology
MH  - Hypoparathyroidism/blood/*drug therapy/epidemiology/urine
MH  - Male
MH  - Middle Aged
MH  - Parathyroid Hormone/adverse effects/blood/*therapeutic use
MH  - Recombinant Proteins/adverse effects/therapeutic use
MH  - Treatment Outcome
EDAT- 2015/12/20 06:00
MHDA- 2016/08/09 06:00
CRDT- 2015/12/20 06:00
PHST- 2015/12/20 06:00 [entrez]
PHST- 2015/12/20 06:00 [pubmed]
PHST- 2016/08/09 06:00 [medline]
AID - S1530-891X(20)39231-4 [pii]
AID - 10.4158/EP15936.OR [doi]
PST - ppublish
SO  - Endocr Pract. 2016 May;22(5):523-32. doi: 10.4158/EP15936.OR. Epub 2015 Dec 18.