Overweight, Polycystic Ovary Syndrome, and Bone Research Study

Condition(s) targeted: Polycystic Ovary Syndrome

Intervention: rosiglitazone (Drug); drospirenone/ethinyl estradiol (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Children's Hospital of Pittsburgh

Official(s) and/or principal investigator(s):
Silva Arslanian, M.D., Principal Investigator, Affiliation: University of Pittsburgh

Overall contact:
Ebony Moorefield, CRNP, Phone: 412-692-5239, Email: moorefielde@upmc.edu

The purpose is to investigate effects of 2 different treatments (drospirenone/ethinyl estradiol versus rosiglitazone) on the bone development, vascular markers, inflammatory markers, insulin sensitivity and androgen levels of overweight adolescent females with polycystic ovary syndrome (PCOS).

Official title: Obesity, Insulin Resistance, and Bone Metabolism in Adolescents With PCOS: Effects of Insulin Sensitizers Versus Oral Contraceptives

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Primary outcome: To compare the effects of 6 months of treatment with drospirenone/ethinyl estradiol versus rosiglitazone on hyperandrogenism, insulin resistance, inflammation and bone turnover.

Secondary outcome: To compare the changes within the PCOS group to normal developmental changes in overweight females without PCOS

Detailed description: The purpose of this study is to:

1) to compare effects of treatment with drospirenone/ethinyl estradiol versus rosiglitazone on hyperandrogenism, insulin resistance/hyperinsulinemia, adrenal hyperresponsiveness, body composition, chronic inflammation, bone mass and turnover.

OCPs are the first-line therapy for PCOS, however, they do not address the insulin resistance or the inflammation. Insulin sensitizers have been used successfully to treat PCOS but thiazolidinediones such as rosiglitazone have not been used in adolescents. Therefore we will investigate the effects of treatment with drospirenone/ethinyl estradiol versus rosiglitazone in overweight adolescents with PCOS. We will obtain comprehensive evaluations before and 6 months after randomization, to the respective treatment arms to determine the differences between the 2 treatment modalities.

Minimum age: 10 Years. Maximum age: 20 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Age 10 - 20 years

- Pubertal level of Tanner stage III-V and menarchal

- BMI percentile for age and sex greater than or equal to 85%ile

Exclusion Criteria:

- Oral medications for PCOS, or that have impact on bone (i. e. anti-epileptics)

- Presence of other diseases, systemic or psychiatric, or chronic medications which

could interfere with endocrine function

- Established diagnosis of diabetes

- Prior bone surgery, prior osteoporotic fracture, or fracture in the past 12 months

- Prior thromboembolic event, such as a deep venous thrombosis or pulmonary embolism

(PCOS subjects only)

- Vitamin D deficiency (<10ng/mL)

- Hyperkalemia (K>5. 0 meq/L)

- Positive pregnancy test (serum)

Ebony Moorefield, CRNP, Phone: 412-692-5239, Email: moorefielde@upmc.edu

Children's Hospital, Pittsburgh, Pennsylvania 15213, United States; Recruiting
Ebony Moorefield, CRNP, Phone: 412-692-5239, Email: moorefielde@upmc.edu
Nancy Guerra, CRNP, Phone: 412-692-8405, Email: guerran@chp.edu
Silva Arslanian, M.D., Principal Investigator

Starting date: March 2005
Ending date: October 2009
Last updated: January 27, 2009