Clinical trial NCT00139685: Depo-Provera: Bone Mineral Density and Total Body Calcium in Adolescent DP150CI Users and Non-Hormonal Contraception
Official title: Depo-Provera: Evaluation of Bone Mineral Density and Total Body Calcium in Adolescent DP 150 CI Users and Matched Controls
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Contraception
Bone Density
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-08-31
Enrollment: 350
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in Bone Mineral Density in adolescent Depo-Provera Contraceptive
measure: Injection (DP150CI) users will be evaluated and compared during depo
measure: medroxyprogesterone acetate (DMPA) therapy and following discontinuation of
measure: DMPA.Another group electing non-hormonal contraception or abstinence is
measure: recruited as a reference population, across all study sites.
Secondary outcomes:
measure: Secondary variables are: Total Body Composition & Total Body Calcium (TBC),
measure: measured by Dual Energy X-ray Absorptiometry (DXA)Surrogate biologic BMD
measure: markers
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Palo Alto
country: United States
facility: Pfizer Investigational Site
state: California
city: Torrance
country: United States
facility: Pfizer Investigational Site
state: California
city: Louisville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Detroit
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Bronx
country: United States
facility: Pfizer Investigational Site
state: New York
city: Cleveland
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Columbus
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Pittsburgh
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Providence
country: United States
facility: Pfizer Investigational Site
state: Rhode Island
city: Norfolk
country: United States
facility: Pfizer Investigational Site
state: Virginia
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: