Of seven participants who discontinued study drug because of repeated hypercalciuria, four were in the teriparatide groups and three in the placebo group.
In plain wordsRepeated high urinary calcium led four people on teriparatide and three on placebo to stop treatment.
- Peptide
- Teriparatide (PTH 1-34)
- Outcome
- Direction not reportedDiscontinuation due to repeated hypercalciuria
- Study
n = 2,074
- Comparator
- Placebo
- Outcome group
- Adverse events · Kidney and urinary
- Studied dose
- 20 and 40 microg/d · Up to 12 monthsAs given in this study (human).
Measurements
- Discontinuations due to repeated hypercalciuria
- 4 participants
- teriparatide groups
- Discontinuations due to repeated hypercalciuria
- 3 participants
- placebo group
- Discontinuations due to repeated hypercalciuria
- 7 participants
- all groups
- Discontinuations due to repeated hypercalciuria
- 0.3%
- all participants
Source sentences
A total of seven participants (0.3%), of which three and four were in the placebo and TPTD groups, respectively, discontinued study drug due to repeated hypercalciuria (>300 mg/d).
3 context sentences(design, population, supporting numbers)
This study included two prospective, randomized, double-blind placebo-controlled clinical trials.
A total of 2074 participants with osteoporosis or low bone mass (study 1, 1637 postmenopausal women; study 2, 437 men) were included.
Participants were given calcium (1000 mg/d) and vitamin D (400-1200 IU/d) supplements, and were randomized to placebo, TPTD 20 mug/d, or TPTD 40 mug/d.