Protocol amendments
| 30 March 2010 | Original protocol (approved as a single site study) |
| 18 January 2011 | Amendment 01: at request of MHRA for authorisationIncorporated changes to wording of exclusion criteria to align these more closely with contraindications to PTH as listed in the SmPC and addition of participant timeline |
| 4 April 2011 | Amendment 02: non-substantial changes to data collection forms |
| 30 August 2011 | Amendment 03: protocol amended to incorporate an additional four recruiting sites due to lower potential participant numbers than anticipated |
| 14 December 2011 | Amendment 04: change to Oxford PI and addition of three further sites |
| 1 February 2012 | Amendment 05: non-substantial amendment. Minor changes to Participant Info Sheet |
| 2 March 2012 | Amendment 07: non-substantial amendment. Minor changes to qualitative Participant Info Sheet |
| 16 April 2012 | Amendment 08: extension to study timescales and revision of target recruitment rate. Addition of recruiting site and removal of recruiting site. |
| 24 June 2012 | Amendment 09: change to Bath PI |
MHRA, medicines and healthcare regulatory agency; PI, principal investigator; PTH, parathyroid harmone; SmPC, Summary of Product Characteristics.