Depo-Provera: Bone Mineral Density and Total Body Calcium in Adolescent DP150CI Users and Non-Hormonal Contraception
Depo-Provera: Bone Mineral Density and Total Body Calcium in Adolescent DP150CI Users and Non-Hormonal Contraception
To evaluate and compare Bone Mineral Density (BMD) in adolescent Depo-Provera Contraceptive
 Injection (DP150CI) users during depo medroxyprogesterone acetate (DMPA) therapy and
 following discontinuation of DMPA. Another group electing non-hormonal contraception or
 abstinence will be recruited as a reference population, across all study sites. The primary
 variable is BMD, measured by Dual Energy X-ray Absorptiometry (DXA). Secondary variables are:
 Total Body Composition& Total Body Calcium (TBC), measured by Dual Energy X-ray
 Absorptiometry (DXA), and surrogate biologic BMD markers. Safety will be evaluated by adverse
 event reporting, laboratory evaluations, pregnancies, weight and vital signs.
Inclusion Criteria:

 -  Adolescent females who have had any menses in the 6 months prior to enrollment

 -  Must have a negative pregnancy test

 Exclusion Criteria:

 -  Concomitant medication exclusion use of bone modifying agents, glucocorticoids,
 heparin, and anticonvulsants

 -  Screening Spinal BMD with z score not greater than -2 of matched young normals