1. Effect of Parathyroid Hormone (1-34) on Fractures and Bone Mineral Density in Postmenopausal Women with Osteoporosis Elise Miller

2. Variables of Interest Since we are dealing with Chi-square, there are 2 categorical variables. Since we are dealing with Chi-square, there are 2 categorical variables. Women were placed into 3 groups: Women were placed into 3 groups: 1.)Placebo 1.)Placebo N=544 N=544 2.)PTH 20-µg 2.)PTH 20-µg N=541 N=541 3.)PTH 40-µg 3.)PTH 40-µg N=552 N=552

3. Variables of Interest cont. The second variable was whether or not new nonvertebral fractures had developed since the baseline examinations. The second variable was whether or not new nonvertebral fractures had developed since the baseline examinations. Or whether or not new fragility fractures developed. Or whether or not new fragility fractures developed.

4. From Table 3

5. To Compare the P-Values… Placebo and Treatment were taken as the explanatory variables. Placebo and Treatment were taken as the explanatory variables. Whether there were new fractures was used as the response variable. Whether there were new fractures was used as the response variable.

6. Minitab Procedure For example: For example: Placebo: N=544 Placebo: N=544 Fracture= 53 Fracture= 53 No Fracture= 491 No Fracture= 491 PTH 20: N=541 PTH 20: N=541 Fracture=34 Fracture=34 No Fracture= 507 No Fracture= 507 These numbers get inputted into MiniTab to find the P-value.

7. MiniTab Output C1 C2 Total C1 C2 Total 1 53 491 544 1 53 491 544 43.62 500.38 43.62 500.38 2.017 0.176 2.017 0.176 2 34 507 541 2 34 507 541 43.38 497.62 43.38 497.62 2.028 0.177 2.028 0.177 Total 87 998 1085 Chi-Sq = 4.398, DF = 1, P-Value = 0.036

8. Procedure cont. The same procedure was done comparing each dose for total fracture and fragility fracture. The same procedure was done comparing each dose for total fracture and fragility fracture.

9. P-Values Placebo vs. 20µg (Fracture) Placebo vs. 20µg (Fracture) By hand: p=.036 By hand: p=.036 Given: p=.04 Given: p=.04 Placebo vs. 40µg (Fracture) Placebo vs. 40µg (Fracture) By hand: p=.015 By hand: p=.015 Given: p=.02 Given: p=.02 Placebo vs. 20µg (Fragility) Placebo vs. 20µg (Fragility) By hand: p=.015 By hand: p=.015 Given: p=.02 Given: p=.02 Placebo vs. 40µg (Fragility) Placebo vs. 40µg (Fragility) By hand: p=.012 By hand: p=.012 Given: p=.01 Given: p=.01

10. Consequences of Error Type 1: Type 1: Researchers would give out a drug that doesn’t have any benefit to eliminating fracture. Researchers would give out a drug that doesn’t have any benefit to eliminating fracture. Type 2: Type 2: The PTH would be considered ineffective and would not make it to the market. The PTH would be considered ineffective and would not make it to the market.

11. Adverse Effects No significant differences among the three groups regarding death. No significant differences among the three groups regarding death. Because the null states that both treatment and placebo have the same risk factors….. Would the null be accepted or rejected? Because the null states that both treatment and placebo have the same risk factors….. Would the null be accepted or rejected? Regarding death, the null would be accepted because there was not significant difference between treatment and placebo. Regarding death, the null would be accepted because there was not significant difference between treatment and placebo.

12. What if researchers were wrong? What type of error would be committed? What type of error would be committed? Type I: Type I: This error would mean that treatment actually has risk of death. This error would mean that treatment actually has risk of death.

13. Potential Bias Like most medical research, bias is considered and ultimately eliminated. Like most medical research, bias is considered and ultimately eliminated. People had to meet certain criteria in order to participate. People had to meet certain criteria in order to participate.

14. Research Conclusions Treatment of postmenopausal osteoporosis with parathyroid hormone (1-34) decreases the risk of fracture. Treatment of postmenopausal osteoporosis with parathyroid hormone (1-34) decreases the risk of fracture. Increases total-body bone mineral density. Increases total-body bone mineral density. In order to have minimal side effects, with higher bone density results and minimal fracture, the 20µg dose is the most beneficial. In order to have minimal side effects, with higher bone density results and minimal fracture, the 20µg dose is the most beneficial.