Start Date
August 31, 2022
Primary Completion Date
May 31, 2023
Study Completion Date
May 31, 2023
rhPTH(1-84)
Participants will receive a SC injection of initial dose of 50 mcg of rhPTH(1-84) once daily (QD) in the thigh (alternate thigh every day). If albumin-corrected serum calcium (ACSC; \[mg/dL\] = serum calcium \[mg/dL\] +0.8\*\[4-serum albumin (g/dL)\]) is \>2.25 mmol/L (\>9.0 mg/dL), a starting dose of 25 mcg will be considered. At 4 week intervals the rhPTH(1-84) dose may be increased in 25 mcg increments to a maximal dose of 100 mcg SC QD. At any time during the study as needed for safety reasons, rhPTH(1-84) doses may be decreased in 25 mcg decrements to a minimum of 25 mcg QD. If the ACSC is \>2.97 mmol/L (\>11.9 mg/dL), then the investigational product should be stopped until the calcium level is corrected.
Fujita Health University Hospital, Toyoake-shi
University of Occupational and Environmental Health Japan, Kitakyushu-shi
Osaka City University Hospital, Osaka
Shimane University Hospital, Izumo-shi
Tokushima University Hospital, Tokushima
University of Tokyo Hospital, Bunkyō City
The Cancer Institute Hospital of JFCR, Kōtoku
Toranomon Hospital, Minatoku
Keio University Hospital, Shinjuku-ku
Tokyo Women's Medical University Hospital, Shinjuku-ku
Lead Sponsor
Shire
INDUSTRY