The United States has one of the highest adolescent pregnancy rates among industrialized nations. One of the major contributing factors is inadequate contraception. A very effective contraceptive method is depot-medroxyprogesterone acetate (DMPA) which has become increasingly popular in this age group. Recent research in adults has suggested a negative effect of DMPA on bone mineral density (BMD). With decreased BMD, one's risk increases later for osteoporosis, a major public health problem affecting millions of postmenopausal women every year. Compromised BMD would appear to be a particular concern in adolescents, as they normally accrue up to 40% of their total bone mineral content during this period. In preliminary work, the investigators demonstrated a 3.0% decrease in BMD in adolescent DMPA users over 2 years, compared with a 9.0% increase in untreated controls (p<0.0001). A prospective cohort study of the effects of DMPA on adolescent BMD, which will also include a double-blinded randomized prevention component, is proposed. Bone density in 400 adolescent DMPA initiators will be compared to their baseline values and to that of 300 and 120, oral and barrier contraceptive initiators, respectively, frequency matched on age and race. Bone density will be measured every six months for a maximum of two years. Bone density will also be measured at the time of discontinuation of contraceptive method. To evaluate the protective effects of estrogen on bone density, females in the DMPA treatment arm will be randomly assigned to DMPA with estradiol (n=200) and DMPA without estradiol (n=200). To examine the question of whether age modifies the effect of DMPA on bone density, the investigators will evaluate the age-treatment interaction between DMPA use and bone density among females of varying gynecologic ages. Finally, sex hormone levels and indices of calcium metabolism will be compared among the treatment groups in order to explore the biologic mechanisms underlying BMD changes. The statistical analysis will estimate the effect of DMPA on bone density while taking account of constant treatment discontinuation throughout the study period.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Research Project (R01)
Project #
1R01HD039009-01
Application #
2679232
Study Section
Epidemiology and Disease Control Subcommittee 2 (EDC)
Program Officer
Kaufman, Steven
Project Start
1999-09-01
Project End
2004-08-31
Budget Start
1999-09-01
Budget End
2000-08-31
Support Year
1
Fiscal Year
1999
Total Cost
Indirect Cost
Name
Case Western Reserve University
Department
Pediatrics
Type
Schools of Medicine
DUNS #
077758407
City
Cleveland
State
OH
Country
United States
Zip Code
44106
Bonny, Andrea E; Secic, Michelle; Cromer, Barbara (2011) Early weight gain related to later weight gain in adolescents on depot medroxyprogesterone acetate. Obstet Gynecol 117:793-7
Bonny, Andrea E; Secic, Michelle; Cromer, Barbara A (2011) Relationship between weight and bone mineral density in adolescents on hormonal contraception. J Pediatr Adolesc Gynecol 24:35-8
Bonny, Andrea E; Secic, Michelle; Cromer, Barbara A (2009) A longitudinal comparison of body composition changes in adolescent girls receiving hormonal contraception. J Adolesc Health 45:423-5
Cromer, Barbara A; Bonny, Andrea E; Stager, Margaret et al. (2008) Bone mineral density in adolescent females using injectable or oral contraceptives: a 24-month prospective study. Fertil Steril 90:2060-7
Stager, Margaret; Harvey, Raymond; Secic, Michelle et al. (2006) Self-reported physical activity and bone mineral density in urban adolescent girls. J Pediatr Adolesc Gynecol 19:17-22
Bonny, Andrea E; Ziegler, Julie; Harvey, Ray et al. (2006) Weight gain in obese and nonobese adolescent girls initiating depot medroxyprogesterone, oral contraceptive pills, or no hormonal contraceptive method. Arch Pediatr Adolesc Med 160:40-5
Harkness, Laura S; Cromer, Barbara A (2005) Vitamin D deficiency in adolescent females. J Adolesc Health 37:75
Cromer, Barbara A; Lazebnik, Rina; Rome, Ellen et al. (2005) Double-blinded randomized controlled trial of estrogen supplementation in adolescent girls who receive depot medroxyprogesterone acetate for contraception. Am J Obstet Gynecol 192:42-7
Cromer, Barbara A; Binkovitz, Larry; Ziegler, Julie et al. (2004) Reference values for bone mineral density in 12- to 18-year-old girls categorized by weight, race, and age. Pediatr Radiol 34:787-92
Rome, Ellen; Ziegler, Julie; Secic, Michelle et al. (2004) Bone biochemical markers in adolescent girls using either depot medroxyprogesterone acetate or an oral contraceptive. J Pediatr Adolesc Gynecol 17:373-7

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