Abstract
Purpose The present study examined the efficacy and safety of a lower rhPTH(1–84) dose. Methods RELAY was a dose-blinded, multicenter, 8-week study of patients with hypoparathyroidism randomized to fixed 25- or 50-μg/d doses of subcutaneous rhPTH(1–84). The primary end point was the percentage of patients at week 8 with supplement reductions in calcium to ≤500 mg/d and in calcitriol to ≤0.25 μg/d, while maintaining serum calcium levels between 1.875 mmol/L and the upper limit of normal. The secondary end point was the percentage of patients at week 8 with a ≥50% reduction in calcium and calcitriol doses, while maintaining serum calcium levels between 1.875 mmol/L and the upper limit of normal. Findings Forty-two patients were randomized (25-μg group, n = 19; 50-μg group, n = 23). At week 8, the primary end point was achieved by 4 (21%; 95% CI, 6%–46%) and 6 (26%; 95% CI, 10%–48%) of the patients receiving 25 and 50 μg/d of rhPTH(1–84), respectively. The secondary end point was achieved by 2 (11%; 95% CI, 1%–33%) and 6 (26%; 95% CI, 10%–48%) of the patients receiving 25 and 50 μg/d of rhPTH(1–84), respectively. Treatment-emergent adverse events were reported by 11 (58%) patients in the 25-μg group and 17 (74%) patients in the 50-μg group. Implications Doses as low as 25 µg/d of rhPTH(1–84) are well tolerated and may be effective for a subset of patients. ClinicalTrials.gov identifier: NCT01268098.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 2096-2102 |
| Number of pages | 7 |
| Journal | Clinical Therapeutics |
| Volume | 39 |
| Issue number | 10 |
| DOIs | |
| State | Published - Oct 1 2017 |
Fingerprint
Keywords
- calcium
- clinical trial
- hypoparathyroidism
- recombinant human parathyroid hormone
- vitamin D
ASJC Scopus subject areas
- Pharmacology
- Pharmacology (medical)
Cite this
Safety and Efficacy of Recombinant Human Parathyroid Hormone in Adults With Hypoparathyroidism Randomly Assigned to Receive Fixed 25-μg or 50-μg Daily Doses. / Bilezikian, John P.; Clarke, Bart; Mannstadt, Michael; Rothman, Jeffrey; Vokes, Tamara; Lee, Hak Myung; Krasner, Alan.
In: Clinical Therapeutics, Vol. 39, No. 10, 01.10.2017, p. 2096-2102.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Safety and Efficacy of Recombinant Human Parathyroid Hormone in Adults With Hypoparathyroidism Randomly Assigned to Receive Fixed 25-μg or 50-μg Daily Doses
AU - Bilezikian, John P.
AU - Clarke, Bart
AU - Mannstadt, Michael
AU - Rothman, Jeffrey
AU - Vokes, Tamara
AU - Lee, Hak Myung
AU - Krasner, Alan
PY - 2017/10/1
Y1 - 2017/10/1
N2 - Purpose The present study examined the efficacy and safety of a lower rhPTH(1–84) dose. Methods RELAY was a dose-blinded, multicenter, 8-week study of patients with hypoparathyroidism randomized to fixed 25- or 50-μg/d doses of subcutaneous rhPTH(1–84). The primary end point was the percentage of patients at week 8 with supplement reductions in calcium to ≤500 mg/d and in calcitriol to ≤0.25 μg/d, while maintaining serum calcium levels between 1.875 mmol/L and the upper limit of normal. The secondary end point was the percentage of patients at week 8 with a ≥50% reduction in calcium and calcitriol doses, while maintaining serum calcium levels between 1.875 mmol/L and the upper limit of normal. Findings Forty-two patients were randomized (25-μg group, n = 19; 50-μg group, n = 23). At week 8, the primary end point was achieved by 4 (21%; 95% CI, 6%–46%) and 6 (26%; 95% CI, 10%–48%) of the patients receiving 25 and 50 μg/d of rhPTH(1–84), respectively. The secondary end point was achieved by 2 (11%; 95% CI, 1%–33%) and 6 (26%; 95% CI, 10%–48%) of the patients receiving 25 and 50 μg/d of rhPTH(1–84), respectively. Treatment-emergent adverse events were reported by 11 (58%) patients in the 25-μg group and 17 (74%) patients in the 50-μg group. Implications Doses as low as 25 µg/d of rhPTH(1–84) are well tolerated and may be effective for a subset of patients. ClinicalTrials.gov identifier: NCT01268098.
AB - Purpose The present study examined the efficacy and safety of a lower rhPTH(1–84) dose. Methods RELAY was a dose-blinded, multicenter, 8-week study of patients with hypoparathyroidism randomized to fixed 25- or 50-μg/d doses of subcutaneous rhPTH(1–84). The primary end point was the percentage of patients at week 8 with supplement reductions in calcium to ≤500 mg/d and in calcitriol to ≤0.25 μg/d, while maintaining serum calcium levels between 1.875 mmol/L and the upper limit of normal. The secondary end point was the percentage of patients at week 8 with a ≥50% reduction in calcium and calcitriol doses, while maintaining serum calcium levels between 1.875 mmol/L and the upper limit of normal. Findings Forty-two patients were randomized (25-μg group, n = 19; 50-μg group, n = 23). At week 8, the primary end point was achieved by 4 (21%; 95% CI, 6%–46%) and 6 (26%; 95% CI, 10%–48%) of the patients receiving 25 and 50 μg/d of rhPTH(1–84), respectively. The secondary end point was achieved by 2 (11%; 95% CI, 1%–33%) and 6 (26%; 95% CI, 10%–48%) of the patients receiving 25 and 50 μg/d of rhPTH(1–84), respectively. Treatment-emergent adverse events were reported by 11 (58%) patients in the 25-μg group and 17 (74%) patients in the 50-μg group. Implications Doses as low as 25 µg/d of rhPTH(1–84) are well tolerated and may be effective for a subset of patients. ClinicalTrials.gov identifier: NCT01268098.
KW - calcium
KW - clinical trial
KW - hypoparathyroidism
KW - recombinant human parathyroid hormone
KW - vitamin D
UR - http://www.scopus.com/inward/record.url?scp=85029578826&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85029578826&partnerID=8YFLogxK
U2 - 10.1016/j.clinthera.2017.08.011
DO - 10.1016/j.clinthera.2017.08.011
M3 - Article
C2 - 28942334
AN - SCOPUS:85029578826
VL - 39
SP - 2096
EP - 2102
JO - Clinical Therapeutics
JF - Clinical Therapeutics
SN - 0149-2918
IS - 10
ER -