Medroxyprogesterone Acetate (Page 5 of 7)

14.3 Bone Mineral Density Changes in Adolescent Females (12 to 18 Years of Age) Treated with Medroxyprogesterone Acetate Injectable Suspension

The impact of medroxyprogesterone acetate injectable suspension (150 mg) use for up to 240 weeks (4.6 years) was evaluated in an open-label non-randomized clinical study in 389 adolescent females (12 to 18 years of age). Use of medroxyprogesterone acetate injectable suspension was associated with a significant decline from baseline in BMD.

Partway through the trial, drug administration was stopped (at 120 weeks). The mean number of injections per medroxyprogesterone acetate injectable suspension user was 9.3. Table 5 summarizes the study findings. The decline in BMD at total hip and femoral neck was greater with longer duration of use. The mean decrease in BMD at 240 weeks was more pronounced at total hip (-6.4%) and femoral neck (-5.4%) compared to lumbar spine (-2.1%).

Adolescents in the untreated cohort had an increase in BMD during the period of growth following menarche. However, the two cohorts were not matched at baseline for age, gynecologic age, race, BMD and other factors that influence the rate of acquisition of BMD.

Table 5. BMD Mean Percent Change from Baseline in Adolescents Receiving ≥4 Injections per 60-week Period, by Skeletal Site and Cohort

Medroxyprogesterone acetate injectable suspension

(150 mg IM)

Unmatched, Untreated Cohort

Duration of Treatment

N

Mean % Change

N

Mean % Change

Total Hip BMD

Week 60 (1.2 years) Week 120 (2.3 years)

Week 240 (4.6 years)

113

73

28

-2.75

-5.40

-6.40

166

109

84

1.22

2.19

1.71

Femoral Neck BMD Week 60

Week 120

Week 240

113

73

28

-2.96

-5.30

-5.40

166

108

84

1.75

2.83

1.94

Lumbar Spine BMD Week 60

Week 120

Week 240

114

73

27

-2.47

-2.74

-2.11

167

109

84

3.39

5.28

6.40

BMD Recovery Post-Treatment in Adolescents

Longer duration of treatment and smoking were associated with less recovery of BMD following the last injection of medroxyprogesterone acetate injectable suspension. Table 6 shows the extent of recovery of BMD up to 60 months post-treatment for adolescents who received medroxyprogesterone acetate injectable suspension for two years or less compared to more than two years. Post-treatment follow-up showed that, in women treated for more than two years, only lumbar spine BMD recovered to baseline levels after treatment was discontinued. Adolescents treated with medroxyprogesterone acetate injectable suspension for more than two years did not recover to their baseline BMD level at femoral neck and total hip even up to 60 months post-treatment. Adolescents in the untreated cohort gained BMD throughout the trial period (data not shown) [see Warnings and Precautions (5.1)].

Table 6. BMD Recovery (Months Post-Treatment) in Adolescents by Years of Medroxyprogesterone Acetate Injectable Suspension Use (2 Years or Less vs. More than 2 Years)

Duration of

Treatment

2 years or less

More than 2 years

N

Mean % Change

from baseline

N

Mean % Change

from baseline

Total Hip BMD

End of Treatment

49

-1.5%

49

-6.2%

12 M post-treatment

33

-1.4%

24

-4.6%

24 M post-treatment

18

0.3%

17

-3.6%

36 M post-treatment

12

2.1%

11

-4.6%

48 M post-treatment

10

1.3%

9

-2.5%

60 M post-treatment

3

0.2%

2

-1.0%

Femoral Neck BMD

End of Treatment

49

-1.6%

49

-5.8%

12 M post-treatment

33

-1.4%

24

-4.3%

24 M post-treatment

18

0.5%

17

-3.8%

36 M post-treatment

12

1.2%

11

-3.8%

48 M post-treatment

10

2.0%

9

-1.7%

60 M post-treatment

3

1.0%

2

-1.9%

Lumbar Spine BMD

End of Treatment

49

-0.9%

49

-3.5%

12 M post-treatment

33

0.4%

23

-1.1%

24 M post-treatment

18

2.6%

17

1.9%

36 M post-treatment

12

2.4%

11

0.6%

48 M post-treatment

10

6.5%

9

3.5%

60 M post-treatment

3

6.2%

2

5.7%

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