loratadine has been researched along with Bone Diseases in 6 studies
Loratadine: A second-generation histamine H1 receptor antagonist used in the treatment of allergic rhinitis and urticaria. Unlike most classical antihistamines (HISTAMINE H1 ANTAGONISTS) it lacks central nervous system depressing effects such as drowsiness.
loratadine : A benzocycloheptapyridine that is 6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridine substituted by a chloro group at position 8 and a 1-(ethoxycarbonyl)piperidin-4-ylidene group at position 11. It is a H1-receptor antagonist commonly employed in the treatment of allergic disorders.
Bone Diseases: Diseases of BONES.
Excerpt | Relevance | Reference |
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"In this open-label study (NCT01712009), women ≥ 18 years of age with newly diagnosed stage I-III breast cancer and an ECOG performance status ≤ 2 who were planning ≥ 4 cycles of adjuvant or neoadjuvant chemotherapy with pegfilgrastim support starting in cycle 1 were randomized 1:1:1 to receive naproxen, loratadine, or no treatment to prevent pegfilgrastim-associated bone pain." | 9.27 | NOLAN: a randomized, phase 2 study to estimate the effect of prophylactic naproxen or loratadine vs no prophylactic treatment on bone pain in patients with early-stage breast cancer receiving chemotherapy and pegfilgrastim. ( Garcia, J; Guinigundo, AS; Kirshner, JJ; Kruter, F; Maxwell, CL; McDonald, MC; Morrow, PK; Reiner, M; Upchurch, TE; Vanni, L, 2018) |
"This pilot study aimed to ascertain if bone pain induced by granulocyte-colony stimulating factors (G-CSFs) can be alleviated or eliminated by oral antihistamine loratadine." | 7.91 | Oral loratadine in the management of G-CSF-induced bone pain: a pilot study. ( Blazkova, S; Costello, V; Dowling, M; Duggan, C; Leary, EO; Murphy, L; Yousif, AD, 2019) |
"Febrile neutropenia is an oncologic emergency that can result in serious consequences." | 5.42 | Severe pegfilgrastim-induced bone pain completely alleviated with loratadine: A case report. ( Copeland, L; Li, Q; Romeo, C, 2015) |
"In this open-label study (NCT01712009), women ≥ 18 years of age with newly diagnosed stage I-III breast cancer and an ECOG performance status ≤ 2 who were planning ≥ 4 cycles of adjuvant or neoadjuvant chemotherapy with pegfilgrastim support starting in cycle 1 were randomized 1:1:1 to receive naproxen, loratadine, or no treatment to prevent pegfilgrastim-associated bone pain." | 5.27 | NOLAN: a randomized, phase 2 study to estimate the effect of prophylactic naproxen or loratadine vs no prophylactic treatment on bone pain in patients with early-stage breast cancer receiving chemotherapy and pegfilgrastim. ( Garcia, J; Guinigundo, AS; Kirshner, JJ; Kruter, F; Maxwell, CL; McDonald, MC; Morrow, PK; Reiner, M; Upchurch, TE; Vanni, L, 2018) |
"This pilot study aimed to ascertain if bone pain induced by granulocyte-colony stimulating factors (G-CSFs) can be alleviated or eliminated by oral antihistamine loratadine." | 3.91 | Oral loratadine in the management of G-CSF-induced bone pain: a pilot study. ( Blazkova, S; Costello, V; Dowling, M; Duggan, C; Leary, EO; Murphy, L; Yousif, AD, 2019) |
"Type of cancer, treatment, age, and BMI were not significant predictors of bone pain." | 1.46 | Prevention of granulocyte-colony stimulating factor (G-CSF) induced bone pain using double histamine blockade. ( Abrams, M; Gavioli, E, 2017) |
"Febrile neutropenia is an oncologic emergency that can result in serious consequences." | 1.42 | Severe pegfilgrastim-induced bone pain completely alleviated with loratadine: A case report. ( Copeland, L; Li, Q; Romeo, C, 2015) |
Timeframe | Studies, this research(%) | All Research% |
---|---|---|
pre-1990 | 0 (0.00) | 18.7374 |
1990's | 0 (0.00) | 18.2507 |
2000's | 0 (0.00) | 29.6817 |
2010's | 5 (83.33) | 24.3611 |
2020's | 1 (16.67) | 2.80 |
Authors | Studies |
---|---|
Gajarawala, SN | 1 |
Pelkowski, JN | 1 |
DeStephano, CC | 1 |
Kirshner, JJ | 1 |
McDonald, MC | 1 |
Kruter, F | 1 |
Guinigundo, AS | 1 |
Vanni, L | 1 |
Maxwell, CL | 1 |
Reiner, M | 1 |
Upchurch, TE | 1 |
Garcia, J | 1 |
Morrow, PK | 1 |
Duggan, C | 1 |
Murphy, L | 1 |
Costello, V | 1 |
Leary, EO | 1 |
Yousif, AD | 1 |
Blazkova, S | 1 |
Dowling, M | 1 |
Romeo, C | 1 |
Li, Q | 1 |
Copeland, L | 1 |
Moukharskaya, J | 1 |
Abrams, DM | 1 |
Ashikaga, T | 1 |
Khan, F | 1 |
Schwartz, J | 1 |
Wilson, K | 1 |
Verschraegen, C | 1 |
Openshaw, T | 1 |
Valentine, J | 1 |
Eneman, J | 1 |
Unger, P | 1 |
Ades, S | 1 |
Gavioli, E | 1 |
Abrams, M | 1 |
Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
---|---|---|---|---|---|---|---|
Randomized, Phase 2 Study to Estimate the Effect of Prophylactic Intervention With Naproxen or Loratadine on Bone Pain in Breast Cancer Subjects Receiving Chemotherapy and Pegfilgrastim[NCT01712009] | Phase 2 | 600 participants (Actual) | Interventional | 2012-11-01 | Completed | ||
Randomized Phase II Pilot Study of Loratadine for the Prevention of Pain Caused by the Granulocyte Colony Stimulating Factor Pegfilgrastim[NCT01311336] | Phase 2 | 55 participants (Anticipated) | Interventional | 2011-05-31 | Recruiting | ||
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
Bone pain data were captured as part of standard adverse event (AE) reporting. (NCT01712009)
Timeframe: Cycle 1 (approximately 4 weeks, depending on the chemotherapy dosing interval)
Intervention | percentage of participants (Number) |
---|---|
No Prophylaxis | 46.6 |
Naproxen 500 mg BID | 40.3 |
Loratadine 10 mg QD | 42.5 |
Patient-reported bone pain AUC was calculated using the trapezoidal rule with bone pain scores from day 1 to 5 for each cycle. The AUC across cycles is the average of AUCs across the cycle. (NCT01712009)
Timeframe: Five consecutive days during each cycle beginning on the day of pegfilgrastim administration (Day 2, 3, or 4 of each cycle)
Intervention | units on a scale * days (Least Squares Mean) | ||||
---|---|---|---|---|---|
Cycle 1 (n=191, 196, 200) | Cycle 2 (n=178, 180, 193) | Cycle 3 (n=165, 176, 188) | Cycle 4 (n=162, 169, 179) | Across All Cycles (n=191, 196, 200) | |
Loratadine 10 mg QD | 7.0 | 5.9 | 6.1 | 5.6 | 6.3 |
Naproxen 500 mg BID | 7.7 | 5.6 | 5.5 | 5.2 | 6.6 |
No Prophylaxis | 9.3 | 7.3 | 6.8 | 7.2 | 8.0 |
Participants completed a brief bone pain survey once per day for 5 days beginning the day they received their pegfilgrastim injection. The bone pain survey collected the severity of pain using a 0 (no pain) to 10 (worst pain) scale. Maximum patient-reported bone pain is the maximum of each participant's bone pain values across survey Days 1-5 within each cycle. Across all cycles the maximum is the maximum of each patient-reported bone pain value across all survey days 1-5 and across all cycles. An ANOVA model with treatment as explanatory term was used. (NCT01712009)
Timeframe: Five consecutive days during each cycle beginning on the day of pegfilgrastim administration (Day 2, 3, or 4 of each cycle)
Intervention | units on a scale (Least Squares Mean) | ||||
---|---|---|---|---|---|
Cycle 1 (n=191, 196, 200) | Cycle 2 (n=178, 180, 193) | Cycle 3 (n=165, 176, 188) | Cycle 4 (n=162, 169, 179) | Across All Cycles (n=191, 196, 200) | |
Loratadine 10 mg QD | 3.0 | 2.6 | 2.5 | 2.1 | 4.1 |
Naproxen 500 mg BID | 3.3 | 2.4 | 2.2 | 2.1 | 4.2 |
No Prophylaxis | 3.9 | 3.0 | 2.7 | 2.8 | 4.7 |
Participants completed a brief bone pain survey once per day for 5 days beginning the day they received their pegfilgrastim injection. The bone pain survey collected the severity of pain using a 0 (no pain) to 10 (worst pain) scale. Mean patient-reported bone pain values are the average of each participant's bone pain values across survey days 1-5 within each cycle. Across all cycles the mean is the average of each patient-reported bone pain value across all survey days 1-5 and across all cycles. An analysis of variance (ANOVA) model with treatment as explanatory term was used. (NCT01712009)
Timeframe: Five consecutive days during each cycle beginning on the day of pegfilgrastim administration (Day 2, 3, or 4 of each cycle)
Intervention | units on a scale (Least Squares Mean) | ||||
---|---|---|---|---|---|
Cycle 1 (n=191, 196, 200) | Cycle 2 (n=178, 180, 193) | Cycle 3 (n=165, 176, 188) | Cycle 4 (n=162, 169, 179) | Across all Cycles (n=191, 196, 200) | |
Loratadine 10 mg QD | 1.7 | 1.4 | 1.4 | 1.3 | 1.5 |
Naproxen 500 mg BID | 1.8 | 1.3 | 1.3 | 1.2 | 1.5 |
No Prophylaxis | 2.2 | 1.7 | 1.6 | 1.7 | 1.9 |
"Severity was graded using CTCAE version 3. A serious adverse event (SAE) is defined as an adverse event that meets at least 1 of the following serious criteria: • fatal; • life threatening; • requires in-patient hospitalization or prolongation of existing hospitalization; • results in persistent or significant disability/incapacity; • congenital anomaly/birth defect; • other medically important serious event.~The investigator assessed each adverse event for relatedness to investigational product(s) or other protocol-required therapies." (NCT01712009)
Timeframe: From first dose of investigational product (IP, naproxen or loratidine) or first dose of pegfilgrastim (Peg), whichever occurred first, until 30 days after last dose, up to 24 weeks.
Intervention | participants (Number) | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Any adverse event | Worst grade of ≥ 2 | Worst grade of ≥ 3 | Worst grade of ≥ 4 | Serious adverse events | Fatal adverse events | AE leading to discontinuation from study | SAE leading to discontinuation from study | Any adverse event related to IP | SAE related to IP | AE related to IP leading to discontinuation of IP | SAE related to IP leading to discontinuation of IP | Any adverse event related to pegfilgrastim | SAE related to pegfilgrastim | AE related to / leading to discontinuation of Peg | SAE related to / leading to discontinuation of Peg | |
Loratadine 10 mg QD | 194 | 168 | 63 | 20 | 14 | 0 | 3 | 2 | 7 | 0 | 0 | 0 | 105 | 1 | 6 | 0 |
Naproxen 500 mg BID | 192 | 169 | 73 | 30 | 30 | 0 | 5 | 3 | 30 | 1 | 9 | 1 | 96 | 0 | 3 | 0 |
No Prophylaxis | 188 | 164 | 74 | 18 | 34 | 0 | 3 | 1 | 0 | 0 | 0 | 0 | 87 | 4 | 6 | 1 |
Bone pain data were captured as part of standard adverse event (AE) reporting. (NCT01712009)
Timeframe: Cycles 1, 2, 3 and 4 (approximately 4 weeks each, depending on the chemotherapy dosing interval)
Intervention | percentage of participants (Number) | |||
---|---|---|---|---|
Cycle 2 (n=178, 180, 193) | Cycle 3 (n=165, 176, 188) | Cycle 4 (n=162, 169, 179) | Across All Cycles (n=191, 196, 200) | |
Loratadine 10 mg QD | 34.7 | 36.2 | 38.0 | 61.0 |
Naproxen 500 mg BID | 34.4 | 34.1 | 40.2 | 59.2 |
No Prophylaxis | 34.3 | 33.9 | 40.7 | 63.4 |
Bone pain data were captured as part of standard adverse event reporting. Severe bone pain is defined as grade 3 or 4 according to common terminology criteria for adverse events (CTCAE) version 3 grading criteria: Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, and Grade 4 = Life-threatening or disabling. (NCT01712009)
Timeframe: Cycles 1, 2, 3 and 4 (approximately 4 weeks each, depending on the chemotherapy dosing interval)
Intervention | percentage of participants (Number) | ||||
---|---|---|---|---|---|
Cycle 1 (n=191, 196, 200) | Cycle 2 (n=178, 180, 193) | Cycle 3 (n=165, 176, 188) | Cycle 4 (n=162, 169, 179) | Across All Cycles (n=191, 196, 200) | |
Loratadine 10 mg QD | 4.5 | 0.0 | 0.0 | 0.0 | 4.5 |
Naproxen 500 mg BID | 3.1 | 1.7 | 1.1 | 0.6 | 4.1 |
No Prophylaxis | 4.7 | 1.1 | 1.8 | 1.9 | 5.8 |
2 trials available for loratadine and Bone Diseases
Article | Year |
---|---|
NOLAN: a randomized, phase 2 study to estimate the effect of prophylactic naproxen or loratadine vs no prophylactic treatment on bone pain in patients with early-stage breast cancer receiving chemotherapy and pegfilgrastim.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Bone Diseases; Breas | 2018 |
Randomized phase II study of loratadine for the prevention of bone pain caused by pegfilgrastim.
Topics: Adult; Aged; Aged, 80 and over; Bone Diseases; Female; Filgrastim; Granulocyte Colony-Stimulating Fa | 2016 |
4 other studies available for loratadine and Bone Diseases
Article | Year |
---|---|
Can loratadine help in treating granulocyte-colony stimulating factor-induced bone pain?
Topics: Bone Diseases; Granulocyte Colony-Stimulating Factor; Humans; Loratadine; Musculoskeletal Pain; Reco | 2021 |
Oral loratadine in the management of G-CSF-induced bone pain: a pilot study.
Topics: Administration, Oral; Adult; Aged; Bone Diseases; Female; Granulocyte Colony-Stimulating Factor; Hum | 2019 |
Severe pegfilgrastim-induced bone pain completely alleviated with loratadine: A case report.
Topics: Aged; Bone Diseases; Female; Filgrastim; Granulocyte Colony-Stimulating Factor; Humans; Loratadine; | 2015 |
Prevention of granulocyte-colony stimulating factor (G-CSF) induced bone pain using double histamine blockade.
Topics: Aged; Antineoplastic Agents; Bone Diseases; Cohort Studies; Famotidine; Febrile Neutropenia; Female; | 2017 |