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Report for Clinical Trial NCT01378299
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
CYP19A1 Gene and Pharmacogenetics of Response
Testosterone (T) replacement prevents bone loss and relieves symptoms associated with androgen deficiency in male patients with hypogonadism, but at the expense of an increase in prostate-related adverse events and in the hematocrit values above the normal which may lead to bad circulatory outcomes. Most of the effects of T on the male skeleton are mediated by its conversion to estradiol (E2) by the enzyme aromatase. Genetic variations in the aromatase (CYP19A1) gene result in enzymes with variable activity and variable levels of E2 and T. This project is designed to determine if genetic variations in the CYP19A1 gene will result in differences in the skeletal response and incidence of side effects from T treatment in patients with low T. A large number of male Veterans are on T. Results from this project will help identify patients who would benefit from the therapy from those at risk for side effects, and would definitely have an impact in the future care of these patients and male patients in general once genetic profiling becomes part of the standard of care.
NCT01378299 Hypogonadism MeSH: Hypogonadism
HPO: Gonadotropin deficiency Hypergonadotropic hypogonadism Hypogonadism Hypogonadotrophic hypogonadism
1 Interventions
Name: Testosterone Cypionate
Description: Testosterone cypionate was administered at 200 mg by intramuscular injection every 2 weeks. DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. It is insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils. The chemical name for testosterone cypionate is androst-4-en-3-one,17-(3-cyclopentyl-1oxopropoxy)-, (178)-. Its molecular formula is CvH400a, and the molecular weight of 412.61.Type: DrugArm 1: Testosterone Cypionate
Primary Outcomes
Description: Percent change in bone mineral density from baseline to 18 months
Measure: Percent Change in Bone Mineral Density (BMD) According to rs700518 Polymorphism in the CYP19A1 Gene Time: form baseline to 18 monthsDescription: Percent change in bone mineral density from baseline to 18 months.
Measure: Percent Change in Bone Mineral Density (BMD) According to the rs1062033 Polymorphism in the CYP19A1 Gene Time: baseline to 18 monthsSecondary Outcomes
Description: Percent changes in bone mineral density from baseline
Measure: Percent Change in Bone Mineral Density According to Body Mass Index (BMI) Time: baseline to 18 monthsDescription: Percent change in PSA from baseline to 18 months
Measure: Percent Change in Prostate-specific Antigen (PSA) According to the rs700518 Polymorphism of the CYP19A1 Gene Time: From baseline to 18 monthsDescription: Percent change in PSA from baseline at 18 months
Measure: Percent Change in Prostate-specific Antigen (PSA) According to the rs1062033 Polymorphism of the CYP19A1 Gene Time: from baseline to 18 monthsDescription: Percent change in hematocrit from baseline to 18 months
Measure: Percent Change in Hematocrit According to the Genotype of the 700518 Polymorphism of the CYP19A1gene Time: baseline to 18 monthsDescription: Percent change in hematocrit from baseline to 18 months
Measure: Percent Change in Hematocrit According to re1062033 Polymorphism of the CYP19A1 Gene Time: Baseline to 18 monthsDescription: Percent change in gene expression from baseline to 18 months
Measure: Percent Change in Aromatase Gene Activity From the Buffy Coat According to the 700518 Polymorphism of the CYP19A1 Gene Time: Baseline to 6 monthsDescription: Percent change in bone turnover from baseline to 18 months.
Measure: Percent Change in Bone Turnover Markers According to the rs700518 Polymorphism of the CYP19A1 Gene Time: Baseline to 18 monthsDescription: Percent change in bone turnover markers
Measure: Percent Change in Bone Turnover Markers According to the rs1062033 Polymorphism of the CYP19A1 Gene Time: Baseline to 18 monthsDescription: Percent change in bone mineral density from baseline to 18 months
Measure: Percent Change in Bone Mineral Density According the Presence of Diabetes Mellitus Time: Baseline to 18 monthsDescription: Percent change in bone turnover markers from baseline to 18 months.
Measure: Percent Change in Bone Turnover Markers According the Presence of Diabetes Mellitus Time: Baseline to 18 monthsPurpose: Other
Single Group Assignment
There are 2 SNPs
SNPs
1 rs1062033
Percent Change in Bone Mineral Density (BMD) According to the rs1062033 Polymorphism in the CYP19A1 Gene.
Percent Change in Prostate-specific Antigen (PSA) According to the rs1062033 Polymorphism of the CYP19A1 Gene.
Percent change in bone turnover from baseline to 18 months.. Percent Change in Bone Turnover Markers According to the rs1062033 Polymorphism of the CYP19A1 Gene.
2 rs700518
Percent Change in Bone Mineral Density (BMD) According to rs700518 Polymorphism in the CYP19A1 Gene.
Percent Change in Prostate-specific Antigen (PSA) According to the rs700518 Polymorphism of the CYP19A1 Gene.
Percent Change in Bone Turnover Markers According to the rs700518 Polymorphism of the CYP19A1 Gene.