Depo-Provera: Bone Mineral Density and Total Body Calcium in Adolescent DP150CI Users and Non-Hormonal Contraception - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00139685

Purpose

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.

Condition	Intervention	Phase
Contraception Bone Density	Drug: Depo-Provera Contraceptive Injection - DP150CI	Phase IV

MedlinePlus related topics: Birth Control Calcium Minerals X-Rays

Drug Information available for: Calcium gluconate Medroxyprogesterone Medroxyprogesterone 17-acetate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
Official Title:	Depo-Provera: Evaluation of Bone Mineral Density and Total Body Calcium in Adolescent DP 150 CI Users and Matched Controls

Further study details as provided by Pfizer:

Primary Outcome Measures:

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 Outcome Measures:

Secondary variables are: Total Body Composition & Total Body Calcium (TBC),
measured by Dual Energy X-ray Absorptiometry (DXA)Surrogate biologic BMD
markers

Estimated Enrollment:	350
Study Start Date:	April 1998
Study Completion Date:	July 2007
Primary Completion Date:	August 2006 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	12 Years to 18 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00139685

Locations

United States, California
Pfizer Investigational Site
Palo Alto, California, United States
Pfizer Investigational Site
Los Angeles, California, United States
Pfizer Investigational Site
Torrance, California, United States
United States, Kentucky
Pfizer Investigational Site
Louisville, Kentucky, United States
United States, Maryland
Pfizer Investigational Site
Baltimore, Maryland, United States
United States, Michigan
Pfizer Investigational Site
Detroit, Michigan, United States
United States, New York
Pfizer Investigational Site
Bronx, New York, United States
United States, Ohio
Pfizer Investigational Site
Columbus, Ohio, United States
Pfizer Investigational Site
Cleveland, Ohio, United States
United States, Pennsylvania
Pfizer Investigational Site
Pittsburgh, Pennsylvania, United States
United States, Rhode Island
Pfizer Investigational Site
Providence, Rhode Island, United States
United States, Virginia
Pfizer Investigational Site
Norfolk, Virginia, United States

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org posting. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure )
Study ID Numbers:	Z54000261
Study First Received:	August 29, 2005
Last Updated:	September 23, 2008
ClinicalTrials.gov Identifier:	NCT00139685
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Calcium, Dietary
Medroxyprogesterone 17-Acetate
Medroxyprogesterone

Additional relevant MeSH terms:

Antineoplastic Agents, Hormonal
Antineoplastic Agents
Contraceptive Agents
Therapeutic Uses
Physiological Effects of Drugs
Contraceptives, Oral

Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Reproductive Control Agents
Contraceptive Agents, Male
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009