prednisone and Bisphosphonate Osteonecrosis

prednisone has been researched along with Bisphosphonate Osteonecrosis in 2 studies

Prednisone: A synthetic anti-inflammatory glucocorticoid derived from CORTISONE. It is biologically inert and converted to PREDNISOLONE in the liver.
prednisone : A synthetic glucocorticoid drug that is particularly effective as an immunosuppressant, and affects virtually all of the immune system. Prednisone is a prodrug that is converted by the liver into prednisolone (a beta-hydroxy group instead of the oxo group at position 11), which is the active drug and also a steroid.

Research

Studies (2)

Authors

Clinical Trials (2)

Trial Overview

Trial Outcomes

Overall Survival

Overall survival is defined as the time from randomization to date of death from any cause. (NCT00887198)
Timeframe: From randomization (Day 1) up to end of study (Month 60)

Radiographic Progression-free Survival (rPFS)

The rPFS was defined as the time from randomization to the occurrence of one of the following: 1) a participant was considered to have progressed by bone scan if - a) the first bone scan with greater than or equal to (>=) 2 new lesions compared to baseline was observed in less than (<) 12 weeks from randomization and was confirmed by a second bone scan taken >=6 weeks later showing >=2 additional new lesions (a total of >=4 new lesions compared to baseline), b) the first bone scan with >=2 new lesions compared to baseline was observed in >=12 weeks from randomization and the new lesions were verified on the next bone scan >=6 weeks later (a total of >=2 new lesions compared to baseline); 2) progression of soft tissue lesions measured by computerized tomography (CT) or magnetic resonance imaging (MRI); 3) death from any cause. (NCT00887198)
Timeframe: From randomization (Day 1) up to first radiographic progression or cutoff date (Month 18)

Time to Deterioration in Eastern Cooperative Oncology Group (ECOG) Performance Score by >=1 Point

The time interval from the date of randomization to the first date at which there was at least a 1 grade change (worsening) in the ECOG performance status grade. Participants who had no deterioration in ECOG performance status grade at the time of the analysis were censored at the last known date of no deterioration. ECOG is a 5-point scale, where 0=Fully active, 1=Ambulatory, carry out work of sedentary nature, 2=Ambulatory, capable of all self-care, 3=Capable of limited self-care, confined to bed or chair more than 50% of waking hours, 4=Completely disabled, no self-care, totally confined to bed or chair, 5=Dead. Participants with no assessment were censored at the date of randomization. (NCT00887198)
Timeframe: From randomization (Day 1) up to first radiographic progression or cutoff date (Month 18)

Time to Initiation of Cytotoxic Chemotherapy

The time interval from the date of randomization to the date of initiation of cytotoxic chemotherapy for prostate cancer. Participants who had no cytotoxic chemotherapy administration at the time of analysis were censored at the last known date when no cytotoxic chemotherapy was administered. Participants with no assessment were censored at the date of randomization. (NCT00887198)
Timeframe: From randomization (Day 1) up to initiation of cytotoxic chemotherapy or cutoff date (Month 18)

Time to Opiate Use for Prostate Cancer Pain

The time interval from the date of randomization to the date of opiate use for cancer pain. Participants who have no opiate use at the time of analysis were censored at the last known date of no opiate use for cancer pain. Participants with no assessment were censored at the date of randomization. (NCT00887198)
Timeframe: From randomization (Day 1) up to first opiate use or end of study (Month 60)

Time to Prostate-specific Antigen (PSA) Progression

The time interval from the date of randomization to the date of PSA progression as defined in the protocol-specific prostate cancer Working Group 2 (PCWG2) criteria. A participant was considered to have a PSA progression if the PSA level had a 25 percent (%) or greater increase from nadir and an absolute increase of 2 nanogram/milliliter ((ng/mL) or more, which is confirmed by a second value obtained in 3 or more weeks. Participants who had no PSA progression at the time of the analysis were censored at the last known date of no PSA progression. Participants with no on-study PSA assessment or no baseline PSA assessment were censored at the date of randomization. (NCT00887198)
Timeframe: From randomization (Day 1) up to date of PSA progerssion or cutoff date (Month 18)

Number of Participants With Treatment Emergent Adverse Events

An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study drug and up to 30 days after last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state. (NCT00887198)
Timeframe: From first dose of study drug up to 30 days after the last dose of study drug

Other Studies

2 other studies available for prednisone and Bisphosphonate Osteonecrosis