Detecting and treating growth hormone deficiency
Described herein is a new oral method for using MK-0677 for detecting growth hormone (GH) deficiency (GHD). Also described is a method of treating growth hormone (GH) deficiency (GHD) in children with a functional hypothalamic-pituitary GH axis.
1. A method of treating growth hormone deficiency (GHD) in children, comprising: administering a therapeutically effective amount of MK-0677 to a child known to have short stature and equivalent growth potential compared to rhGH, wherein the therapeutically effective amount is 0.1-2.0 mg/kg/d and a child has equivalent growth potential compared to rhGH when the child has:
(i.) a peak serum GH≥5 μg/L in response to a single oral dose of MK-0677; and,
(ii.) a baseline serum IGF-I of >30 ng/mL.
2. The method of claim 1 , wherein a single, oral 0.8 mg/kg/d dose of MK-0677 is administered.
3. The method of claim 1 , wherein MK-0677 is orally administered via at least one mini-tablet, comprising: MK-0677.
4. The method of claim 3 , wherein the mini-tablet, comprises: 2 mg of MK-0677.
5. The method of claim 1 , wherein the GHD is pediatric GHD.
6. The method of claim 1 , wherein MK-0677 is orally administered and the orally administering, further comprises: administering with the assistance of a device capable of dispensing at least one MK-0677 mini-tablet.
7. A method of treating GHD in children, comprising:
a testing a child known to have short stature for GHD using a theranostic test; and,
b orally administering a therapeutically effective amount of MK-0677 to a child found to have short stature and equivalent growth potential compared to rhGH;
wherein the therapeutically effective amount is 0.1-2.0 mg/kg/d and a child has equivalent growth potential compared to rhGH when the child has:
(i.) a peak serum GH≥5 μg/L in response to a single oral dose of MK-0677; and,
(ii.) a baseline serum IGF-I of >30 ng/mL.
8. The method of claim 7 , wherein a single, oral 0.8 mg/kg/d dose of MK-0677 is administered.
9. The method of claim 7 , wherein MK-0677 is orally administered via at least one mini-tablet, comprising: MK-0677.
10. The method of claim 9 , wherein the mini-tablet, comprises: 2 mg of MK-0677.
11. The method of claim 7 , wherein the orally administering, further comprises: administering with the assistance of a device capable of dispensing at least one MK-0677 mini-tablet.
12. The method of claim 7 , wherein the GHD is pediatric GHD.
13. The method of claim 7 , wherein the theranostic test, comprises:
(iii.) testing for a peak serum GH≥5 μg/L in response to a single oral dose of MK-0677; and,
(iv.) testing for a baseline serum IGF-I of >30 ng/mL.
14. The method of claim 13 , wherein a single, oral 0.8 mg/kg/d dose of MK-0677 is administered in step (i).
15. The method of claim 1 , wherein the therapeutically effective amount is 0.8 mg/kg/d of MK-0677.
16. The method of claim 1 , wherein the therapeutically effective amount is 1.6 mg/kg/d of MK-0677.
17. The method of claim 7 , wherein the therapeutically effective amount is 0.8 mg/kg/d of MK-0677.
18. The method of claim 7 , wherein the therapeutically effective amount is 1.6 mg/kg/d of MK-0677.
19. The method of claim 3 , wherein the mini-tablet, comprises: 4 mg of MK-0677.
20. The method of claim 9 , wherein the mini-tablet, comprises: 4 mg of MK-0677.
21. The method of claim 1 , wherein the treatment is maintained for more than 6 months.
22. The method of claim 1 , wherein the treatment is maintained for at least 7 months.
23. The method of claim 1 , wherein the treatment is maintained until growth potential is exhausted.
24. The method of claim 7 , wherein the treatment is maintained for more than 6 months.
25. The method of claim 7 , wherein the treatment is maintained for at least 7 months.
26. The method of claim 7 , wherein the treatment is maintained until growth potential is exhausted.