Table 4B.

Required sample size to test all secondary hypotheses in main study.

Hypothesis	Clinically Important Difference	Standard Deviation of Change	Subjects, per group
Hip BMD will be higher in treatment group*	2%	4.5% (5, 59, 62, 80, 81)	107
NTx will lower in treatment group†	15% (69, 87–89)	28% (30, 35)	105
BSAP will be higher in treatment group†	15% (69, 87–89)	25% (30)	105
Headaches due to nitrates will be higher in treatment group**	20% (30)	5% (30)	36
Trabecular bone density by pQCT will be higher in treatment group**	10 mg/cm3 (67, 70)	7.5 mg/cm3 (67, 70)	31

* Based on a t-test, assuming a two sided alpha of 0.05 a power of 0.90 and a standard deviation of change in BMD measurements of 4.5%.

† Assuming a repeated measures analysis of variance (75).

** Based on a Student's t test, assuming a two sided alpha of 0.05, a power of 0.90.