| Outcome Measures: |
Primary: Percentage of Participants With at Least One Incidence of Hypercalcemia, Hypercalcemia was defined as calcium \>10.2 mg/dL. Percentage of participants with hypercalcemia is presented for the overall population, the subgroup of participants in the study for less than 3 months, and those in the study for greater than or equal to 3 months., Monitored from time of informed consent through end of study + 30 days (total of 745 days). | Secondary: Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), Deaths and Discontinuations Due to AEs, AE: any untoward medical occurrence that does not necessarily have a causal relationship with treatment; any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered causally related to the use of the product (either paricalcitol or calcitriol); can result from use of the drug as stipulated in the labeling, as well as from accidental or intentional overdose, drug abuse, or drug withdrawal; any worsening of a pre-existing condition or illness. Severity was categorized as mild, moderate, or severe. SAE: AE that results in the death; is life-threatening; results in hospitalization or prolongation of hospitalization; is a congenital anomaly; results in persistent or significant disability/incapacity; is an important medical event requiring medical or surgical intervention to prevent serious outcome; is a spontaneous or elective abortion. For more details, please see the AE section of this record., Monitored from time of informed consent through end of study + 30 days (total of 745 days).|Mean Baseline (BL) and Change From Baseline in Potassium, Sodium, Chloride, Bicarbonate at Final Visit (FV), Normal ranges for these chemistry measurements varied according to the age of the participant., Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])|Mean Baseline (BL) and Change From Baseline in Calcium, Inorganic Phosphate (IP), Blood Urea Nitrogen (BUN), Creatinine at Final Visit (FV), Normal ranges for these chemistry measurements varied according to the age of the participant., Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])|Mean Baseline and Change From Baseline in 25-Hydroxy Vitamin D3 at Final Visit (FV), Normal ranges for these chemistry measurements varied according to the age of the participant., Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])|Mean Baseline and Change From Baseline in 1,25-Dihydroxy Vitamin D3 at Final Visit (FV), Normal ranges for these chemistry measurements varied according to the age of the participant., Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])|Mean Baseline and Change From Baseline in Parathyroid Hormone at Final Visit (FV), Normal ranges for these chemistry measurements varied according to the age of the participant., Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])|Mean Baseline and Change From Baseline in Albumin at Final Visit (FV), Normal ranges for these chemistry measurements varied according to the age of the participant., Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])
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| Locations: |
Site Reference ID/Investigator# 37082, Birmingham, Alabama, 35255, United States|Site Reference ID/Investigator# 26762, Gainesville, Florida, 32610, United States|Site Reference ID/Investigator# 28529, Orlando, Florida, 32801, United States|Site Reference ID/Investigator# 26748, Atlanta, Georgia, 30322, United States|Site Reference ID/Investigator# 37582, New Orleans, Louisiana, 70118, United States|Site Reference ID/Investigator# 39973, Baltimore, Maryland, 21287, United States|Site Reference ID/Investigator# 26769, Boston, Massachusetts, 02115, United States|Site Reference ID/Investigator# 26768, Detroit, Michigan, 48201, United States|Site Reference ID/Investigator# 26747, Kansas City, Missouri, 64108, United States|Site Reference ID/Investigator# 26749, Akron, Ohio, 44308, United States|Site Reference ID/Investigator# 26751, Cincinnati, Ohio, 45229, United States|Site Reference ID/Investigator# 26765, Columbus, Ohio, 43205, United States|Site Reference ID/Investigator# 28528, Oklahoma City, Oklahoma, 73104, United States|Site Reference ID/Investigator# 26763, Portland, Oregon, 97227, United States|Site Reference ID/Investigator# 28526, Charlottesville, Virginia, 22908, United States|Site Reference ID/Investigator# 26758, Seattle, Washington, 98105, United States|Site Reference ID/Investigator# 40382, Madison, Wisconsin, 53792, United States|Site Reference ID/Investigator# 26759, Wauwatosa, Wisconsin, 53226, United States
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