Study Complete
Sponsor ID
20010141
12-month Study of AMG 073 in Renal Osteodystrophy
Study Details
4 doses of AMG 073 or placebo over 52 weeks after a 30-day screening period. Throughout the study, labs will be drawn to measure analytes such as iPTH and corrected calcium. In addition, a bone biopsy will be performed at screening and at the end of study.
Protocol Summary
Primary Outcome Measures
To evaluate the effects of AMG 073 compared with placebo on renal osteodystrophy as assessed by bone histomorphometry
Timeframe: entire study
Secondary Outcome Measures
To evaluate the effects of AMG 073 compared with placebo on intact parathyroid hormone (iPTH), bone-specific alkaline phosphatase (BALP), serum N-Telopeptide (N-Tx), and calcium x phosphorus product concentrations
Timeframe: entire study
To evaluate the feasibility of measuring physical activity with accelerometry
Timeframe: entire study
To evaluate the safety and tolerability of AMG 073 compared with placebo
Timeframe: entire study
Locations
No locations found.