Overweight, Polycystic Ovary Syndrome, and Bone Research Study - Full Text View

Sponsored by:	Children's Hospital of Pittsburgh
Information provided by:	Children's Hospital of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00640224

Purpose

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).

Condition	Intervention	Phase
Polycystic Ovary Syndrome	Drug: rosiglitazone Drug: drospirenone/ethinyl estradiol	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Obesity, Insulin Resistance, and Bone Metabolism in Adolescents With PCOS: Effects of Insulin Sensitizers Versus Oral Contraceptives

Resource links provided by NLM:

Drug Information available for: Estradiol Estradiol 3-benzoate Ethinyl estradiol Polyestradiol phosphate Depogen 1,2-Dihydrospirorenone Estradiol dipropionate Rosiglitazone Rosiglitazone Maleate Estradiol cypionate Estradiol valerate Estradiol acetate

U.S. FDA Resources

Further study details as provided by Children's Hospital of Pittsburgh:

Primary Outcome Measures:

To compare the effects of 6 months of treatment with drospirenone/ethinyl estradiol versus rosiglitazone on hyperandrogenism, insulin resistance, inflammation and bone turnover. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To compare the changes within the PCOS group to normal developmental changes in overweight females without PCOS [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	75
Study Start Date:	March 2005
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone	Drug: rosiglitazone 4 mg daily for 6 months
2: Active Comparator Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol	Drug: drospirenone/ethinyl estradiol 1 tab (3mg/30mcg) daily for 6 months
3: No Intervention Overweight adolescent females without PCOS to use as comparison of normal developmental changes.

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.

Eligibility

Ages Eligible for Study:	10 Years to 20 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00640224

Contacts

Contact: Ebony Moorefield, CRNP	412-692-5239	moorefielde@upmc.edu
Contact: Nancy Guerra, CRNP	412-692-8405	guerran@chp.edu

Locations

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

Sponsors and Collaborators

Children's Hospital of Pittsburgh

Investigators

Principal Investigator:

Silva Arslanian, M.D.

University of Pittsburgh

More Information

No publications provided

Responsible Party:	University of Pittsburgh ( Silva Arslanian, M.D. )
Study ID Numbers:	0503013, 2K24HD001357
Study First Received:	March 18, 2008
Last Updated:	January 27, 2009
ClinicalTrials.gov Identifier:	NCT00640224 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Gonadal Disorders
Contraceptive Agents
Hormone Antagonists
Estradiol valerate
Contraceptives, Oral
Hormones, Hormone Substitutes, and Hormone Antagonists
Overweight
Ovarian Diseases
Estradiol 17 beta-cypionate
Hormones
Polycystic Ovarian Syndrome
Insulin
Genital Diseases, Female
Hypoglycemic Agents
Estradiol 3-benzoate

Drospirenone
Polyestradiol phosphate
Rosiglitazone
Obesity
Estrogens
Endocrine System Diseases
Ethinyl Estradiol
Cysts
Estradiol
Aldosterone Antagonists
Polycystic Ovary Syndrome
Endocrinopathy
Insulin Resistance
Ovarian Cysts

Additional relevant MeSH terms:

Estrogens
Disease
Gonadal Disorders
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Endocrine System Diseases
Ethinyl Estradiol
Ovarian Diseases
Cysts
Hormones
Pharmacologic Actions

Adnexal Diseases
Genital Diseases, Female
Neoplasms
Hypoglycemic Agents
Pathologic Processes
Aldosterone Antagonists
Syndrome
Polycystic Ovary Syndrome
Drospirenone
Rosiglitazone
Ovarian Cysts

ClinicalTrials.gov processed this record on September 10, 2009