Schedule of assessments
| Baseline visit | Additional safety bloods for participants <30 kg only | 4- monthly TPTD supply | 6- monthly telephone contact | 1- month visit | 24-month visit | 6-monthly telephone contact | End of study visit | |||
| 2 weeks | 4 weeks | 12 weeks | ||||||||
| Informed consent | X | |||||||||
| Inclusion/exclusion | X | |||||||||
| Demographic data | X | |||||||||
| Medical history | X | |||||||||
| Clinical exam | X | X | X | X | ||||||
| DXA | X* | X | X* | |||||||
| Spine X-ray | X | X | ||||||||
| HR-pQCT | X* | X | X | X* | ||||||
| Safety bloods | X | X | X | X | X | X | X | |||
| Sample for genetic analysis | X | |||||||||
| Biochemical markers | X | X | X | X | ||||||
| Pregnancy test | X | X | ||||||||
| Participant Questionnaire Pack | X | X | X | X | ||||||
| Training on treatment | X | |||||||||
| Treatment diary issue | X | |||||||||
| Diary data entry | X | X | X | X | X | X | ||||
| TPTD accountability | X | X | X | X | ||||||
| Adverse events | X | X | X | X | X | X | ||||
| Medications check | X | X | X | X | X | X | ||||
| ZA infusion | X | |||||||||
| X-rays for incident fractures † | X | X | X | X | X | |||||
*Not required for participants who have had a 24-month visit DXA scan or HR-pQCT scan within 3 months of the end of trial visit.
†X-rays may be taken at any point throughout the trial when participants report the occurrence of possible incident fractures.
DXA, dual-energy X-ray absorptiometry; HR-pQCT, High Resolution Peripheral Quantitative Computed Tomography ; TPTD, teriparatide; ZA, zoledronic acid.