letrozole and Arthralgia studies

Research Excerpts

Excerpt	Relevance	Reference
"Purpose The Letrozole (Femara) Versus Anastrozole Clinical Evaluation (FACE) study compared the efficacy and safety of adjuvant letrozole versus anastrozole in postmenopausal patients with hormone receptor (HR) -positive and node-positive early breast cancer (eBC)."	9.24	Comparative Efficacy and Safety of Adjuvant Letrozole Versus Anastrozole in Postmenopausal Patients With Hormone Receptor-Positive, Node-Positive Early Breast Cancer: Final Results of the Randomized Phase III Femara Versus Anastrozole Clinical Evaluation ( Amadori, D; Burris, H; Comarella, L; De Boer, R; Dowsett, M; Ejlertsen, B; Gnant, M; Hart, L; Jonat, W; McIntyre, K; O'Shaughnessy, J; Poggio, S; Pritchard, KI; Salomon, H; Smith, I; Wamil, B; Yardley, D, 2017)
"Vitamin D3 supplementation significantly improved serum 25-hydroxy vitamin D concentrations and decreased letrozole-induced arthralgia."	9.22	Effects of vitamin D and calcium supplementation on side effects profile in patients of breast cancer treated with letrozole. ( Ananthanarayanan, PH; Arul Vijaya Vani, S; Harichandrakumar, KT; Kadambari, D; Nandeesha, H; Niranjjan, R, 2016)
"Our results suggested that BMI and AI drug (letrozole versus anastrozole) were clinical predictors of arthralgia, while genetic variants rs4775936, rs9322336, rs2234693, and rs9340799 were genetic predictors of AI-induced arthralgia."	7.96	Genetic and clinical predictors of arthralgia during letrozole or anastrozole therapy in breast cancer patients. ( Borrie, AE; Choi, YH; Hahn, K; Kim, RB; Lenehan, J; Lock, M; Logan, D; Perera, FE; Potvin, K; Read, N; Rose, FA; Sexton, T; Teft, WA; Vandenberg, TA; Welch, S; Yaremko, B; Younus, J; Yu, E, 2020)
"The aromatase inhibitor (AI) letrozole is a first-line drug in the adjuvant treatment of breast cancer in postmenopausal women."	7.88	Letrozole concentration is associated with CYP2A6 variation but not with arthralgia in patients with breast cancer. ( Borrie, AE; Choi, YH; Dinniwell, R; Hahn, K; Kim, RB; Lenehan, J; Lock, M; Logan, D; Perera, FE; Potvin, K; Read, N; Rose, RV; Sexton, T; Teft, WA; Tyndale, RF; Vandenberg, TA; Welch, S; Yaremko, B; Younus, J; Yu, E, 2018)
" This study was conducted to determine the prevalence of suboptimal vitamin D levels in women initiating adjuvant letrozole for breast cancer and to determine whether supplementation with 50,000 IU of vitamin D3 weekly could reduce musculoskeletal symptoms and fatigue in women who have suboptimal vitamin D levels."	7.76	Effect of vitamin D supplementation on serum 25-hydroxy vitamin D levels, joint pain, and fatigue in women starting adjuvant letrozole treatment for breast cancer. ( Baxa, SE; Fabian, CJ; Khan, QJ; Kimler, BF; Klemp, JR; O'Dea, AP; Reddy, PS; Sharma, P, 2010)
"The development of joint pain was similar in the two groups."	6.90	Preexisting musculoskeletal burden and its development under letrozole treatment in early breast cancer patients. ( Almstedt, K; Baake, G; Bayer, CM; Beckmann, MW; Brodkorb, T; Brucker, C; Brucker, SY; Fasching, PA; Fehm, T; Fischer, G; Fridman, A; Gass, P; Graf, H; Häberle, L; Hack, CC; Harbeck, N; Hartkopf, AD; Hein, A; Heindl, F; Hoffmann, O; Janni, W; Kohls, A; Kolberg, HC; Krabisch, P; Kuemmel, S; Lindner, C; Loehberg, CR; Lux, MP; Maass, N; Malter, W; Martin, B; Nabieva, N; Pelzer, V; Rack, B; Rauh, C; Rody, A; Schulz, V; Steinfeld-Birg, D; Thomssen, C; Volz, B; Walter, CB; Weigel, M; Wolf, C; Wuerstlein, R, 2019)
"Purpose The Letrozole (Femara) Versus Anastrozole Clinical Evaluation (FACE) study compared the efficacy and safety of adjuvant letrozole versus anastrozole in postmenopausal patients with hormone receptor (HR) -positive and node-positive early breast cancer (eBC)."	5.24	Comparative Efficacy and Safety of Adjuvant Letrozole Versus Anastrozole in Postmenopausal Patients With Hormone Receptor-Positive, Node-Positive Early Breast Cancer: Final Results of the Randomized Phase III Femara Versus Anastrozole Clinical Evaluation ( Amadori, D; Burris, H; Comarella, L; De Boer, R; Dowsett, M; Ejlertsen, B; Gnant, M; Hart, L; Jonat, W; McIntyre, K; O'Shaughnessy, J; Poggio, S; Pritchard, KI; Salomon, H; Smith, I; Wamil, B; Yardley, D, 2017)
"Vitamin D3 supplementation significantly improved serum 25-hydroxy vitamin D concentrations and decreased letrozole-induced arthralgia."	5.22	Effects of vitamin D and calcium supplementation on side effects profile in patients of breast cancer treated with letrozole. ( Ananthanarayanan, PH; Arul Vijaya Vani, S; Harichandrakumar, KT; Kadambari, D; Nandeesha, H; Niranjjan, R, 2016)
"Our results suggested that BMI and AI drug (letrozole versus anastrozole) were clinical predictors of arthralgia, while genetic variants rs4775936, rs9322336, rs2234693, and rs9340799 were genetic predictors of AI-induced arthralgia."	3.96	Genetic and clinical predictors of arthralgia during letrozole or anastrozole therapy in breast cancer patients. ( Borrie, AE; Choi, YH; Hahn, K; Kim, RB; Lenehan, J; Lock, M; Logan, D; Perera, FE; Potvin, K; Read, N; Rose, FA; Sexton, T; Teft, WA; Vandenberg, TA; Welch, S; Yaremko, B; Younus, J; Yu, E, 2020)
"The aromatase inhibitor (AI) letrozole is a first-line drug in the adjuvant treatment of breast cancer in postmenopausal women."	3.88	Letrozole concentration is associated with CYP2A6 variation but not with arthralgia in patients with breast cancer. ( Borrie, AE; Choi, YH; Dinniwell, R; Hahn, K; Kim, RB; Lenehan, J; Lock, M; Logan, D; Perera, FE; Potvin, K; Read, N; Rose, RV; Sexton, T; Teft, WA; Tyndale, RF; Vandenberg, TA; Welch, S; Yaremko, B; Younus, J; Yu, E, 2018)
"Postmenopausal women with an early breast cancer scheduled to start adjuvant endocrine therapy with an AI or tamoxifen were recruited."	3.80	Arthralgia induced by endocrine treatment for breast cancer: A prospective study of serum levels of insulin like growth factor-I, its binding protein and oestrogens. ( Billen, J; Christiaens, MR; Jans, I; Laenen, A; Lintermans, A; Neven, P; Paridaens, R; Pauwels, S; Van Asten, K; Van Herck, E; Vanderschueren, D; Verhaeghe, J; Vermeersch, P; Wildiers, H, 2014)
"We conducted a prospective study including postmenopausal early breast cancer patients receiving either an aromatase inhibitor (AI) or tamoxifen."	3.77	Aromatase inhibitor-induced loss of grip strength is body mass index dependent: hypothesis-generating findings for its pathogenesis. ( Christiaens, MR; De Smet, L; Dieudonné, AS; Henry, NL; Leunen, K; Lintermans, A; Morales, L; Neven, P; Pans, S; Paridaens, R; Timmerman, D; Van Calster, B; Van Hoydonck, M; Vergote, I; Verhaeghe, J; Verschueren, K; Westhovens, R; Wildiers, H, 2011)
" This study was conducted to determine the prevalence of suboptimal vitamin D levels in women initiating adjuvant letrozole for breast cancer and to determine whether supplementation with 50,000 IU of vitamin D3 weekly could reduce musculoskeletal symptoms and fatigue in women who have suboptimal vitamin D levels."	3.76	Effect of vitamin D supplementation on serum 25-hydroxy vitamin D levels, joint pain, and fatigue in women starting adjuvant letrozole treatment for breast cancer. ( Baxa, SE; Fabian, CJ; Khan, QJ; Kimler, BF; Klemp, JR; O'Dea, AP; Reddy, PS; Sharma, P, 2010)
"Patients with breast cancer (BC) show strong interest in complementary and alternative medicine (CAM), particularly for adverse effects of adjuvant endocrine treatment - e."	2.94	Complementary and alternative medicine and musculoskeletal pain in the first year of adjuvant aromatase inhibitor treatment in early breast cancer patients. ( Almstedt, K; Baake, G; Bayer, CM; Beckmann, MW; Brodkorb, T; Brucker, C; Brucker, SY; Fasching, PA; Fehm, T; Fischer, G; Fridman, A; Gass, P; Graf, H; Häberle, L; Hack, CC; Harbeck, N; Hartkopf, AD; Hein, A; Heindl, F; Hoffmann, O; Janni, W; Kohls, A; Kolberg, HC; Krabisch, P; Kuemmel, S; Lindner, C; Loehberg, CR; Lux, MP; Maass, N; Malter, W; Martin, B; Nabieva, N; Pelzer, V; Rack, B; Rauh, C; Rody, A; Schulz, V; Steinfeld-Birg, D; Thomssen, C; Volz, B; Walter, CB; Weigel, M; Willer, L; Wolf, C; Wuerstlein, R, 2020)
"The development of joint pain was similar in the two groups."	2.90	Preexisting musculoskeletal burden and its development under letrozole treatment in early breast cancer patients. ( Almstedt, K; Baake, G; Bayer, CM; Beckmann, MW; Brodkorb, T; Brucker, C; Brucker, SY; Fasching, PA; Fehm, T; Fischer, G; Fridman, A; Gass, P; Graf, H; Häberle, L; Hack, CC; Harbeck, N; Hartkopf, AD; Hein, A; Heindl, F; Hoffmann, O; Janni, W; Kohls, A; Kolberg, HC; Krabisch, P; Kuemmel, S; Lindner, C; Loehberg, CR; Lux, MP; Maass, N; Malter, W; Martin, B; Nabieva, N; Pelzer, V; Rack, B; Rauh, C; Rody, A; Schulz, V; Steinfeld-Birg, D; Thomssen, C; Volz, B; Walter, CB; Weigel, M; Wolf, C; Wuerstlein, R, 2019)

Research

Studies (15)

Authors

Clinical Trials (3)

Trial Overview

Trial Outcomes

Average Percent Adherence to Vitamin D Interventio

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	0 (0.00)	18.2507
2000's	2 (13.33)	29.6817
2010's	11 (73.33)	24.3611
2020's	2 (13.33)	2.80

Authors	Studies
Hack, CC	2
Häberle, L	2
Brucker, SY	2
Janni, W	2
Volz, B	2
Loehberg, CR	2
Hartkopf, AD	2
Walter, CB	2
Baake, G	2
Fridman, A	2
Malter, W	2
Wuerstlein, R	2
Harbeck, N	2
Hoffmann, O	2
Kuemmel, S	2
Martin, B	2
Thomssen, C	2
Graf, H	2
Wolf, C	2
Lux, MP	2
Bayer, CM	2
Rauh, C	2
Almstedt, K	2
Gass, P	2
Heindl, F	2
Brodkorb, T	2
Willer, L	1
Lindner, C	2
Kolberg, HC	2
Krabisch, P	2
Weigel, M	2
Steinfeld-Birg, D	2
Kohls, A	2
Brucker, C	2
Schulz, V	2
Fischer, G	2
Pelzer, V	2
Rack, B	2
Beckmann, MW	2
Fehm, T	2
Rody, A	2
Maass, N	2
Hein, A	2
Fasching, PA	2
Nabieva, N	2
Borrie, AE	2
Rose, FA	1
Choi, YH	2
Perera, FE	2
Read, N	2
Sexton, T	2
Lock, M	2
Vandenberg, TA	2
Hahn, K	2
Younus, J	2
Logan, D	2
Potvin, K	2
Yaremko, B	2
Yu, E	2
Lenehan, J	2
Welch, S	2
Teft, WA	2
Kim, RB	2
Rose, RV	1
Dinniwell, R	1
Tyndale, RF	1
Mao, JJ	1
Farrar, JT	1
Bruner, D	1
Zee, J	1
Bowman, M	1
Seluzicki, C	1
DeMichele, A	1
Xie, SX	1
Lintermans, A	2
Vanderschueren, D	1
Verhaeghe, J	2
Van Asten, K	1
Jans, I	1
Van Herck, E	1
Laenen, A	1
Paridaens, R	2
Billen, J	1
Pauwels, S	1
Vermeersch, P	1
Wildiers, H	2
Christiaens, MR	2
Neven, P	2
Shapiro, AC	1
Adlis, SA	1
Robien, K	1
Kirstein, MN	1
Liang, S	1
Richter, SA	1
Lerner, RE	1
Arul Vijaya Vani, S	1
Ananthanarayanan, PH	1
Kadambari, D	1
Harichandrakumar, KT	1
Niranjjan, R	1
Nandeesha, H	1
Smith, I	1
Yardley, D	1
Burris, H	1
De Boer, R	1
Amadori, D	1
McIntyre, K	1
Ejlertsen, B	1
Gnant, M	1
Jonat, W	1
Pritchard, KI	1
Dowsett, M	1
Hart, L	1
Poggio, S	1
Comarella, L	1
Salomon, H	1
Wamil, B	1
O'Shaughnessy, J	1
Khan, QJ	1
Reddy, PS	1
Kimler, BF	1
Sharma, P	1
Baxa, SE	1
O'Dea, AP	1
Klemp, JR	1
Fabian, CJ	1
Van Calster, B	1
Van Hoydonck, M	1
Pans, S	1
Westhovens, R	1
Henry, NL	1
Dieudonné, AS	1
Leunen, K	1
Morales, L	1
Verschueren, K	1
Timmerman, D	1
De Smet, L	1
Vergote, I	1
Nagykálnai, T	1
Landherr, L	1
Mészáros, E	1
Kubo, M	1
Onishi, H	1
Kuroki, S	1
Okido, M	1
Shimada, K	1
Yokohata, K	1
Umeda, S	1
Ogawa, T	1
Tanaka, M	1
Katano, M	1
Thomas, R	1
Williams, M	1
Marshall, C	1
Walker, L	1
Fontaine, C	1
Meulemans, A	1
Huizing, M	1
Collen, C	1
Kaufman, L	1
De Mey, J	1
Bourgain, C	1
Verfaillie, G	1
Lamote, J	1
Sacre, R	1
Schallier, D	1
Neyns, B	1
Vermorken, J	1
De Grève, J	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
Phase 2 Study Vitamin D3 Effects on Musculoskeletal Symptoms With Use of Aromatase Inhibitors[NCT01509079]	Phase 2	116 participants (Actual)	Interventional	2012-03-31	Completed
A PHASE II Multicentric Trial Evaluating a High Dose Vitamin D Supplementation to Correct the Vitamin D Deficiency for Breast Cancer Treated by Adjuvant Chemotherapy[NCT04091178]	Phase 2	57 participants (Actual)	Interventional	2013-10-10	Completed
LA LEAST- Luminal A, Limited Endocrine Adjuvant Systemic Therapy. A Trial of Abbreviated Hormone Therapy for Low Risk Hormone Receptor Positive, HER2 Negative Early Breast Cancer[NCT03917082]	Phase 2	290 participants (Anticipated)	Interventional	2019-09-23	Active, not recruiting
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

adherence measured with pill counts for the vitamin D at predesignated study timepoints: baseline (after run-in), 3 months and 6 months (NCT01509079)
Timeframe: average for all study ppts for: screening to baseline; baseline to 3 months; 3 month to 6 months

Change in Hand Grip Strength

Change in Musculoskeletal Symptom Sub-scale on the Breast Cancer Prevention Trial Symptom Scale

Intervention	% of adherence for each treatment arm (Number)
Vitamin D3 4000 IU	95
Vitamin D3 600 IU	95

Intervention	pounds (Mean)
Vitamin D3 4000 IU	1.8
Vitamin D3 600 IU	1.0

The MS subscale is a self-reported measure on a scale of 0 to 4, with lower score indicating less arthralgia/myalgia (NCT01509079)
Timeframe: baseline to 6 months

Change in PROMIS Physical Functioning Questionnaire

Intervention	units on a scale (Mean)
Vitamin D3 4000 IU	-0.2
Vitamin D3 600 IU	-0.5

PROMIS measures physical functioning on the short form and higher scores reflect better physical functioning with 10 questions on daily activities of life on a Likert scale ranging from 5 (no problem performing activity) to 1 (cannot do activity). Range on this measure is from 50 (best)-10 (worst). (NCT01509079)
Timeframe: baseline to 6 months

Whole Body Bone Mineral Density

Intervention	units on a scale (Mean)
Vitamin D3 4000 IU	0.6
Vitamin D3 600 IU	1.7

GLM Mean and standard deviation of Whole Body Bone Mineral Density (grams/cm2) of Trial Participants by Treatment Arm after controlling for bisphosphonate use (NCT01509079)
Timeframe: From Baseline and 6 months of D3 supplementation

Change in Steady State Concentrations of Serum Anastrazole and Letrozole

Intervention	gm/cm2 (Geometric Least Squares Mean)
Vitamin D3 4000 IU	1.1
Vitamin D3 600 IU	1.12

Difference in steady state concentrations in plasma from baseline to 6 months (NCT01509079)
Timeframe: baseline to 6 months

Article	Year
Complementary and alternative medicine and musculoskeletal pain in the first year of adjuvant aromatase inhibitor treatment in early breast cancer patients. Breast (Edinburgh, Scotland), 2020, Volume: 50 Topics: Aged; Aromatase Inhibitors; Arthralgia; Breast Neoplasms; Complementary Therapies; Female; Germany;	2020
Preexisting musculoskeletal burden and its development under letrozole treatment in early breast cancer patients. International journal of cancer, 2019, 10-15, Volume: 145, Issue:8 Topics: Aged; Aromatase Inhibitors; Arthralgia; Breast Neoplasms; Female; Humans; Letrozole; Middle Aged; Mu	2019
Electroacupuncture for fatigue, sleep, and psychological distress in breast cancer patients with aromatase inhibitor-related arthralgia: a randomized trial. Cancer, 2014, Dec-01, Volume: 120, Issue:23 Topics: Aged; Anastrozole; Androstadienes; Anxiety; Aromatase Inhibitors; Arthralgia; Breast Neoplasms; Depr	2014
Randomized, blinded trial of vitamin D3 for treating aromatase inhibitor-associated musculoskeletal symptoms (AIMSS). Breast cancer research and treatment, 2016, Volume: 155, Issue:3 Topics: Adult; Aged; Anastrozole; Antineoplastic Agents, Hormonal; Aromatase Inhibitors; Arthralgia; Bone De	2016
Effects of vitamin D and calcium supplementation on side effects profile in patients of breast cancer treated with letrozole. Clinica chimica acta; international journal of clinical chemistry, 2016, Aug-01, Volume: 459 Topics: Arthralgia; Breast Neoplasms; Calcium; Cholecalciferol; Dietary Supplements; Female; Humans; Letrozo	2016
Comparative Efficacy and Safety of Adjuvant Letrozole Versus Anastrozole in Postmenopausal Patients With Hormone Receptor-Positive, Node-Positive Early Breast Cancer: Final Results of the Randomized Phase III Femara Versus Anastrozole Clinical Evaluation Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2017, Apr-01, Volume: 35, Issue:10 Topics: Aged; Anastrozole; Antineoplastic Agents, Hormonal; Arthralgia; Breast Neoplasms; Chemotherapy, Adju	2017
Short-term and low-dose prednisolone administration reduces aromatase inhibitor-induced arthralgia in patients with breast cancer. Anticancer research, 2012, Volume: 32, Issue:6 Topics: Aged; Aged, 80 and over; Anastrozole; Anti-Inflammatory Agents; Aromatase Inhibitors; Arthralgia; Br	2012
Switching to letrozole or exemestane improves hot flushes, mood and quality of life in tamoxifen intolerant women. British journal of cancer, 2008, May-06, Volume: 98, Issue:9 Topics: Affect; Androstadienes; Antineoplastic Agents, Hormonal; Aromatase Inhibitors; Arthralgia; Breast Ne	2008

Article	Year
Genetic and clinical predictors of arthralgia during letrozole or anastrozole therapy in breast cancer patients. Breast cancer research and treatment, 2020, Volume: 183, Issue:2 Topics: Adult; Aged; Aged, 80 and over; Anastrozole; Aromatase; Aromatase Inhibitors; Arthralgia; Biomarkers	2020
Letrozole concentration is associated with CYP2A6 variation but not with arthralgia in patients with breast cancer. Breast cancer research and treatment, 2018, Volume: 172, Issue:2 Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Agents, Hormonal; Aromatase Inhibitors; Arthralgia; B	2018
Arthralgia induced by endocrine treatment for breast cancer: A prospective study of serum levels of insulin like growth factor-I, its binding protein and oestrogens. European journal of cancer (Oxford, England : 1990), 2014, Volume: 50, Issue:17 Topics: Aged; Aged, 80 and over; Anastrozole; Antineoplastic Agents; Antineoplastic Agents, Hormonal; Aromat	2014
Effect of vitamin D supplementation on serum 25-hydroxy vitamin D levels, joint pain, and fatigue in women starting adjuvant letrozole treatment for breast cancer. Breast cancer research and treatment, 2010, Volume: 119, Issue:1 Topics: Aged; Antineoplastic Agents; Aromatase Inhibitors; Arthralgia; Breast Neoplasms; Chemotherapy, Adjuv	2010
Aromatase inhibitor-induced loss of grip strength is body mass index dependent: hypothesis-generating findings for its pathogenesis. Annals of oncology : official journal of the European Society for Medical Oncology, 2011, Volume: 22, Issue:8 Topics: Aged; Anastrozole; Androstadienes; Aromatase Inhibitors; Arthralgia; Body Mass Index; Breast Neoplas	2011
Tolerance of adjuvant letrozole outside of clinical trials. Breast (Edinburgh, Scotland), 2008, Volume: 17, Issue:4 Topics: Aged; Antineoplastic Agents; Aromatase Inhibitors; Arthralgia; Breast Neoplasms; Chemotherapy, Adjuv	2008

letrozole and Arthralgia