Medroxyprogesterone Acetate (Page 5 of 6)
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% |
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.
https://medlibrary.org/lib/rx/meds/medroxyprogesterone-acetate-21/page/5/