Depo-Provera: Bone Mineral Density and Total Body Calcium in Adolescent DP150CI Users and Non-Hormonal Contraception
Status:
Completed
Trial end date:
2007-07-01
Target enrollment:
Participant gender:
Summary
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.