Depo-Provera: Evaluation of Bone Mineral Density and Total Body Calcium in Adolescent DP 150 CI Users and Matched Controls
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 350
- Locations
- 12
- Primary Endpoint
- Changes in Bone Mineral Density in adolescent Depo-Provera Contraceptive
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 12 Years to 18 Years (Child, Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Changes in Bone Mineral Density in adolescent Depo-Provera Contraceptive
Injection (DP150CI) users will be evaluated and compared during depo
medroxyprogesterone acetate (DMPA) therapy and following discontinuation of
DMPA.Another group electing non-hormonal contraception or abstinence is
recruited as a reference population, across all study sites.
Secondary Outcomes
- Secondary variables are: Total Body Composition & Total Body Calcium (TBC),
- measured by Dual Energy X-ray Absorptiometry (DXA)Surrogate biologic BMD
- markers