alendronate and Rheumatic Diseases studies

alendronic acid : A 1,1-bis(phosphonic acid) that is methanebis(phosphonic acid) in which the two methylene hydrogens are replaced by hydroxy and 3-aminopropyl groups.

Rheumatic Diseases: Disorders of connective tissue, especially the joints and related structures, characterized by inflammation, degeneration, or metabolic derangement.

Research Excerpts

Excerpt	Relevance	Reference
"To compare the bone anabolic drug teriparatide (20 microg/day) with the antiresorptive drug alendronate (10 mg/day) for treating glucocorticoid-induced osteoporosis (OP)."	9.14	Effects of teriparatide versus alendronate for treating glucocorticoid-induced osteoporosis: thirty-six-month results of a randomized, double-blind, controlled trial. ( Adler, RA; Devogelaer, JP; Eastell, R; Krege, JH; Krohn, K; Saag, KG; See, K; Warner, MR; Zanchetta, JR, 2009)
"To investigate the effects of alendronate (Alen) on the prevention of systemic glucocorticoid-induced osteoporosis in patients with rheumatic diseases."	9.13	[Alendronate prevents steroid-induced osteoporosis in patients with rheumatic diseases]. ( Huang, YL; Wang, QH; Wen, LH; Wu, HX; Xue, J; Yang, XY; Zhu, L, 2008)
"During this 18-month trial in patients with rheumatic diseases, alendronate was more effective in the prevention of glucocorticoid-induced bone loss than was alfacalcidol."	9.12	Alendronate or alfacalcidol in glucocorticoid-induced osteoporosis. ( Algra, A; Bijlsma, JW; Bruyn, GA; Buskens, E; de Laet, CE; de Nijs, RN; Dijkmans, BA; Geusens, PP; Huisman, AM; Jacobs, JW; Laan, RF; Lems, WF; Oostveen, AC, 2006)
"Alendronate treatment for 12 months in pediatric patients with rheumatic diseases and secondary low bone mass was reported to result in a substantial increase in bone mineral density (BMD)."	9.10	Changes in markers of bone turnover and inflammatory variables during alendronate therapy in pediatric patients with rheumatic diseases. ( Bardare, M; Bianchi, ML; Chiesa, S; Cimaz, R; Corona, F; Dubini, A; Falcini, F; Gattorno, M; Lenhardt, A; Lepore, L; Martini, G; Masi, L; Sormani, MP; Zulian, F, 2002)
"We performed a cross-sectional study to clarify the factors associated with the development of glucocorticoid-induced bone loss and osteoporosis in patients with childhood-onset rheumatic disease and to investigate the impact of the early use of alendronate."	7.88	Early use of alendronate as a protective factor against the development of glucocorticoid-induced bone loss in childhood-onset rheumatic diseases: a cross-sectional study. ( Arima, T; Chiba, K; Inoue, Y; Kohno, Y; Mitsunaga, K; Morita, Y; Nakano, T; Shimojo, N; Suzuki, S; Tomiita, M; Yamaguchi, KI; Yamaide, A; Yamaide, F; Yamamoto, T, 2018)
"Our objective was to investigate the efficacy of intravenous alendronate for the treatment of glucocorticoid-induced osteoporosis (GIOP) in children with autoimmune diseases."	7.74	Efficacy of intravenous alendronate for the treatment of glucocorticoid-induced osteoporosis in children with autoimmune diseases. ( Arima, T; Inoue, Y; Kohno, Y; Minagawa, M; Shimojo, N; Suzuki, S; Tomiita, M, 2008)
"Alendronate was not able to reduce the incidence of vertebral fractures (RR = 0."	6.53	Alendronate prevents glucocorticoid-induced osteoporosis in patients with rheumatic diseases: A meta-analysis. ( Ai, J; Feng, SQ; Kan, SL; Li, Y; Sun, JC; Xu, H; Yuan, ZF, 2016)
"The randomized, clinical trial demonstrated that switching to monthly minodronate from weekly alendronate and risedronate provides greater increases in patients' satisfaction and bone mineral density and more substantial decreases in a bone resorption marker than continuing weekly alendronate and risedronate in patients with systemic rheumatic diseases on glucocorticoid therapy."	5.27	Patient satisfaction and efficacy of switching from weekly bisphosphonates to monthly minodronate for treatment and prevention of glucocorticoid-induced osteoporosis in Japanese patients with systemic rheumatic diseases: a randomized, clinical trial. ( Hayami, Y; Iwagaitsu, S; Maeda, S; Naniwa, T; Ohmura, SI; Sasaki, K; Tamechika, SY, 2018)
"To compare the bone anabolic drug teriparatide (20 microg/day) with the antiresorptive drug alendronate (10 mg/day) for treating glucocorticoid-induced osteoporosis (OP)."	5.14	Effects of teriparatide versus alendronate for treating glucocorticoid-induced osteoporosis: thirty-six-month results of a randomized, double-blind, controlled trial. ( Adler, RA; Devogelaer, JP; Eastell, R; Krege, JH; Krohn, K; Saag, KG; See, K; Warner, MR; Zanchetta, JR, 2009)
"To investigate the effects of alendronate (Alen) on the prevention of systemic glucocorticoid-induced osteoporosis in patients with rheumatic diseases."	5.13	[Alendronate prevents steroid-induced osteoporosis in patients with rheumatic diseases]. ( Huang, YL; Wang, QH; Wen, LH; Wu, HX; Xue, J; Yang, XY; Zhu, L, 2008)
"During this 18-month trial in patients with rheumatic diseases, alendronate was more effective in the prevention of glucocorticoid-induced bone loss than was alfacalcidol."	5.12	Alendronate or alfacalcidol in glucocorticoid-induced osteoporosis. ( Algra, A; Bijlsma, JW; Bruyn, GA; Buskens, E; de Laet, CE; de Nijs, RN; Dijkmans, BA; Geusens, PP; Huisman, AM; Jacobs, JW; Laan, RF; Lems, WF; Oostveen, AC, 2006)
"Alendronate treatment for 12 months in pediatric patients with rheumatic diseases and secondary low bone mass was reported to result in a substantial increase in bone mineral density (BMD)."	5.10	Changes in markers of bone turnover and inflammatory variables during alendronate therapy in pediatric patients with rheumatic diseases. ( Bardare, M; Bianchi, ML; Chiesa, S; Cimaz, R; Corona, F; Dubini, A; Falcini, F; Gattorno, M; Lenhardt, A; Lepore, L; Martini, G; Masi, L; Sormani, MP; Zulian, F, 2002)
"We performed a cross-sectional study to clarify the factors associated with the development of glucocorticoid-induced bone loss and osteoporosis in patients with childhood-onset rheumatic disease and to investigate the impact of the early use of alendronate."	3.88	Early use of alendronate as a protective factor against the development of glucocorticoid-induced bone loss in childhood-onset rheumatic diseases: a cross-sectional study. ( Arima, T; Chiba, K; Inoue, Y; Kohno, Y; Mitsunaga, K; Morita, Y; Nakano, T; Shimojo, N; Suzuki, S; Tomiita, M; Yamaguchi, KI; Yamaide, A; Yamaide, F; Yamamoto, T, 2018)
"Our objective was to investigate the efficacy of intravenous alendronate for the treatment of glucocorticoid-induced osteoporosis (GIOP) in children with autoimmune diseases."	3.74	Efficacy of intravenous alendronate for the treatment of glucocorticoid-induced osteoporosis in children with autoimmune diseases. ( Arima, T; Inoue, Y; Kohno, Y; Minagawa, M; Shimojo, N; Suzuki, S; Tomiita, M, 2008)
"The purpose of the investigation was to test the use of alendronate in the therapy of children affected by chronic rheumatic diseases and symptomatic drug-induced osteoporosis."	3.69	Intravenous administration of alendronate counteracts the in vivo effects of glucocorticoids on bone remodeling. ( Brandi, ML; Ermini, M; Falcini, F; Trapani, S, 1996)
"Alendronate was not able to reduce the incidence of vertebral fractures (RR = 0."	2.53	Alendronate prevents glucocorticoid-induced osteoporosis in patients with rheumatic diseases: A meta-analysis. ( Ai, J; Feng, SQ; Kan, SL; Li, Y; Sun, JC; Xu, H; Yuan, ZF, 2016)

Research

Studies (12)

Authors

Clinical Trials (4)

Trial Overview

Trial Outcomes

Percent Change From Baseline to Week 96 in Lumbar Spine BMD

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	1 (8.33)	18.2507
2000's	7 (58.33)	29.6817
2010's	4 (33.33)	24.3611
2020's	0 (0.00)	2.80

Authors	Studies
Tamechika, SY	1
Sasaki, K	1
Hayami, Y	1
Ohmura, SI	1
Maeda, S	1
Iwagaitsu, S	1
Naniwa, T	1
Inoue, Y	2
Mitsunaga, K	1
Yamamoto, T	1
Chiba, K	1
Yamaide, F	1
Nakano, T	1
Morita, Y	1
Yamaide, A	1
Suzuki, S	2
Arima, T	2
Yamaguchi, KI	1
Tomiita, M	2
Shimojo, N	2
Kohno, Y	2
Tanaka, Y	1
Mori, H	1
Aoki, T	1
Atsumi, T	1
Kawahito, Y	1
Nakayama, H	1
Tohma, S	1
Yamanishi, Y	1
Hasegawa, H	1
Tanimura, K	1
Negoro, N	1
Ueki, Y	1
Kawakami, A	1
Eguchi, K	1
Saito, K	1
Okada, Y	1
Kan, SL	1
Yuan, ZF	1
Li, Y	1
Ai, J	1
Xu, H	1
Sun, JC	1
Feng, SQ	1
Wang, QH	1
Wu, HX	1
Huang, YL	1
Xue, J	1
Yang, XY	1
Zhu, L	1
Wen, LH	1
Stoch, SA	1
Saag, KG	3
Greenwald, M	1
Sebba, AI	1
Cohen, S	1
Verbruggen, N	1
Giezek, H	1
West, J	1
Schnitzer, TJ	1
Zanchetta, JR	1
Devogelaer, JP	1
Adler, RA	1
Eastell, R	1
See, K	1
Krege, JH	1
Krohn, K	1
Warner, MR	1
Cimaz, R	1
Gattorno, M	1
Sormani, MP	1
Falcini, F	2
Zulian, F	1
Lepore, L	1
Bardare, M	1
Chiesa, S	1
Corona, F	1
Dubini, A	1
Lenhardt, A	1
Martini, G	1
Masi, L	1
Bianchi, ML	1
de Nijs, RN	1
Jacobs, JW	1
Lems, WF	1
Laan, RF	1
Algra, A	1
Huisman, AM	1
Buskens, E	1
de Laet, CE	1
Oostveen, AC	1
Geusens, PP	1
Bruyn, GA	1
Dijkmans, BA	1
Bijlsma, JW	1
Curtis, JR	1
Minagawa, M	1
Trapani, S	1
Ermini, M	1
Brandi, ML	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, 12-Month Study to Evaluate the Efficacy and Safety of Oral Alendronate Sodium Once Weekly for the Prevention and Treatment of Glucocorticoid-Induced Bone Loss[NCT00480766]	Phase 3	173 participants (Actual)	Interventional	2001-07-31	Completed
Impact of Oral Alendronate Therapy on Bone Mineral Density in HIV-infected Children and Adolescents With Low Bone Mineral Density[NCT00921557]	Phase 2	52 participants (Actual)	Interventional	2009-11-30	Completed
Prevention of Glucocorticoid-Induced Osteoporosis in Patients With Rheumatic Diseases. The STOP-Study: a Randomized Placebo Controlled Trial With Alendronate Versus Alfacalcidol.[NCT00138983]	Phase 3	200 participants	Interventional	2000-05-31	Completed
Alendronate Versus Placebo for Idiopathic Juvenile Osteoporosis[NCT00001720]	Phase 2	50 participants	Interventional	1998-03-31	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Percent change was calculated as (measurement at week 96 - measurement at baseline)/measurement at baseline * 100%. Includes Groups 1A and 1B only. (NCT00921557)
Timeframe: Weeks 0 and 96

Percent Change From Baseline to Week 96 in Whole Body (With Head) BMD

Intervention	Percent change from baseline (Median)
1A: Alendronate/Alendronate	24.9
1B: Alendronate/Placebo	14.8

Percent change was calculated as (measurement at week 96 - measurement at baseline)/measurement at baseline * 100%. Includes Groups 1A and 1B only. (NCT00921557)
Timeframe: Weeks 0 and 96

Percent Change From Week 48 to Week 96 (Group 1B), Week 48 to Week 144 (Group 1B), and Week 96 to 144 (Group 2) in Lumbar Spine BMD

Intervention	Percent change from baseline (Median)
1A: Alendronate/Alendronate	19.6
1B: Alendronate/Placebo	10.3

Percent change was calculated as (measurement at time T2 - measurement at time T1)/measurement at Time T1 * 100%. (NCT00921557)
Timeframe: Weeks 48, 96 and 144

Percent Change From Week 48 to Week 96 (Group 1B), Week 48 to Week 144 (Group 1B), and Week 96 to 144 (Group 2) in Whole Body (With Head) BMD

Intervention	Percent change (Median)
1B: Alendronate/Placebo (48 Week Change)	0.9
2: Placebo/Alendronate (48 Week Change)	2.0
1B: Alendronate/Placebo (96 Week Change)	1.7

Percent change was calculated as (measurement at time T2 - measurement at time T2)/measurement at time T1 * 100%. (NCT00921557)
Timeframe: Weeks 48, 96 and 144

Percentage of Participants Developing New Signs, Symptoms, Hematology or Chemistry Laboratory Values Greater Than or Equal to Grade 3 or New Cases of Jaw Osteonecrosis, Atrial Fibrillation, or Non-healing Fractures

Intervention	Percent change (Median)
1B: Alendronate/Placebo (48 Week Change)	0.8
2: Placebo/Alendronate (48 Week Change)	0.5
1B: Alendronate/Placebo (96 Week Change)	0.9

Signs, symptoms, and laboratory values were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0 (December 2004). Results for Groups 1A and 1B were combined as both were on alendronate for the first 48 weeks. (NCT00921557)
Timeframe: Week 0 to 48

Change in CD4 Percent From Baseline

Intervention	Participants (Count of Participants)
1: Alendronate	5
2: Placebo	2

Change in percentage of lymphocytes that are CD4 cells calculated as measurement at each time point minus baseline measurement (NCT00921557)
Timeframe: Weeks 0, 48, 96 and 144

Change in Centers for Disease Control (CDC) HIV Disease Category

Intervention	percent of lymphocytes that are CD4 cell (Median)
	Week 48 - Week 0	Week 96 - Week 0	Week 144 - Week 0
1A: Alendronate/Alendronate	0	0	1
1B: Alendronate/Placebo	1	-1	-1
2: Placebo/Alendronate	1	2	-4

Percentage of participants advancing in CDC HIV disease category from baseline throughout study follow-up (NCT00921557)
Timeframe: Weeks 144

Effect of Other Known Bone Mineral Determinants (Age, Gender, Race/Ethnicity, Steroid Use, Depo-Provera, Tenofovir, Pubertal Stage, Bone Age, Vitamin D Status) and Inflammatory Cytokine Levels on Changes in Lumbar Spine BMD

Intervention	Participants (Count of Participants)
	Week 0 to 48	Week 48 to 96	Week 96 to 144
1A: Alendronate/Alendronate	1	0	0
1B: Alendronate/Placebo	0	1	0
2: Placebo/Alendronate	0	0	0

A slope was fit for each participant to their percent change [(measurement at time T - measurement at baseline)/measurement at baseline)*100%] in lumbar spine BMD from baseline. Results represent average changes in lumbar spine BMD over one year. Results are summarized for age, gender, ethnicity, tenofovir use, Tanner stage, bone age and vitamin D level. Only one participant was on steroids and none were using Dep-Provera. Inflammatory cytokine levels were not assayed. Results were combined for Groups 1A and 1B as both were on alendronate for the first 48 weeks. (NCT00921557)
Timeframe: Weeks 0, 24 and 48

Intervention	percentage of baseline (Mean)
	Male	Female	Non-hispanic	Hispanic	11 - < 15 years	15 - < 19 years	>= 19 years	On Tenofovir	Not on Tenofovir	25-OH Vit D<30 ng/ml	25-0H Vit D>=30 ng/ml	Bone age < 15 years	Bone age>=15 years	Tanner stage <= 3	Tanner stage >= 4
1: Alendronate	20.3	25.4	19.4	23.6	37.1	16.5	8.1	24.8	19.9	22.0	22.1	36.0	11.3	33.0	15.4
2: Placebo	6.8	9.4	4.8	7.8	10.6	8.0	1.9	6.8	8.2	6.8	7.8	10.0	5.0	10.6	5.9

A slope was fit for each participant to their percent change [(measurement at time T - measurement at baseline)/measurement at baseline)*100%] in whole body (with head) BMD from baseline. Results represent average changes in whole body (with head) BMD over one year. Results are summarized for age, gender, ethnicity, tenofovir use, Tanner stage, bone age and vitamin D level. Only one participant was on steroids and none were using Dep-Provera. Inflammatory cytokine levels were not assayed. Results were combined for Groups 1A and 1B as both were on alendronate for the first 48 weeks. (NCT00921557)
Timeframe: Weeks 0, 24 and 48

Percent Change From Baseline to Weeks 24 and 48 in Lumbar Spine BMD

Intervention	percentage of baseline (Mean)
	Male	Female	Non-Hispanic	Hispanic	11 - < 15 years	15 - < 19 years	>= 19 years	On tenofovir	Not on tenofovir	25-0H Vit D<30 ng/ml	25-0H Vit D>=30 ng/ml	Bone age < 15 years	Bone age >=15 years	Tanner stage <= 3	Tanner stage >= 4
1: Alendronate	11.4	14.0	9.8	13.9	19.2	10.5	4.7	13.2	11.6	10.6	15.1	19.0	7.7	18.0	9.4
2: Placebo	4.1	8.2	0.3	6.1	8.0	6.5	-0.3	5.0	5.8	5.8	5.2	8.4	2.3	8.0	3.8

Percent change was calculated as (measurement at time T - measurement at baseline)/measurement at baseline * 100%. Results for Groups 1A and 1B combined as both were on alendronate for the first 48 weeks. (NCT00921557)
Timeframe: Weeks 0, 24 and 48

Percent Change From Baseline to Weeks 24 and 48 in Whole Body (With Head) BMD

Intervention	Percent change from baseline (Median)
	Week 24	Week 48
1: Alendronate	14.4	15.9
2: Placebo	5.5	7.1

Percent change was calculated as (measurement at time T - measurement at baseline)/measurement at baseline * 100%. Results for Groups 1A and 1B were combined as both were on alendronate for the first 48 weeks. (NCT00921557)
Timeframe: Weeks 0, 24 and 48

Percent of Participants With HIV-1 RNA <= 400 Copies/ml

Intervention	Percent change from baseline (Median)
	Week 24	Week 48
1: Alendronate	5.5	10.7
2: Placebo	0.3	5.2

Percent calculated as number of participants with HIV-1 RNA <= 400 copies/ml relative to the number of participants with HIV-1 RNA measured at that time point. (NCT00921557)
Timeframe: Weeks 0, 48, 96 and 144

Safety as Measured by the Incidence of New Signs, Symptoms, Hematology or Chemistry Laboratory Values Greater Than or Equal to Grade 3 or New Cases of Jaw Osteonecrosis, Atrial Fibrillation, or Non-healing Fractures

Article	Year
Patient satisfaction and efficacy of switching from weekly bisphosphonates to monthly minodronate for treatment and prevention of glucocorticoid-induced osteoporosis in Japanese patients with systemic rheumatic diseases: a randomized, clinical trial. Archives of osteoporosis, 2018, 06-13, Volume: 13, Issue:1 Topics: Administration, Oral; Adult; Aged; Alendronate; Bone Density; Bone Density Conservation Agents; Diph	2018
Analysis of bone metabolism during early stage and clinical benefits of early intervention with alendronate in patients with systemic rheumatic diseases treated with high-dose glucocorticoid: Early DIagnosis and Treatment of OsteopoRosis in Japan (EDITOR- Journal of bone and mineral metabolism, 2016, Volume: 34, Issue:6 Topics: Adolescent; Adult; Aged; Aged, 80 and over; Alendronate; Bone Density; Female; Fractures, Bone; Gluc	2016
[Alendronate prevents steroid-induced osteoporosis in patients with rheumatic diseases]. Zhonghua yi xue za zhi, 2008, Jul-15, Volume: 88, Issue:27 Topics: Adult; Alendronate; Bone Density; Bone Density Conservation Agents; Female; Glucocorticoids; Humans;	2008
Once-weekly oral alendronate 70 mg in patients with glucocorticoid-induced bone loss: a 12-month randomized, placebo-controlled clinical trial. The Journal of rheumatology, 2009, Volume: 36, Issue:8 Topics: Administration, Oral; Adult; Aged; Alendronate; Biomarkers; Bone Density; Bone Density Conservation	2009
Once-weekly oral alendronate 70 mg in patients with glucocorticoid-induced bone loss: a 12-month randomized, placebo-controlled clinical trial. The Journal of rheumatology, 2009, Volume: 36, Issue:8 Topics: Administration, Oral; Adult; Aged; Alendronate; Biomarkers; Bone Density; Bone Density Conservation	2009
Once-weekly oral alendronate 70 mg in patients with glucocorticoid-induced bone loss: a 12-month randomized, placebo-controlled clinical trial. The Journal of rheumatology, 2009, Volume: 36, Issue:8 Topics: Administration, Oral; Adult; Aged; Alendronate; Biomarkers; Bone Density; Bone Density Conservation	2009
Once-weekly oral alendronate 70 mg in patients with glucocorticoid-induced bone loss: a 12-month randomized, placebo-controlled clinical trial. The Journal of rheumatology, 2009, Volume: 36, Issue:8 Topics: Administration, Oral; Adult; Aged; Alendronate; Biomarkers; Bone Density; Bone Density Conservation	2009
Effects of teriparatide versus alendronate for treating glucocorticoid-induced osteoporosis: thirty-six-month results of a randomized, double-blind, controlled trial. Arthritis and rheumatism, 2009, Volume: 60, Issue:11 Topics: Adult; Aged; Alendronate; Bone Density; Bone Density Conservation Agents; Collagen Type I; Dose-Resp	2009
Changes in markers of bone turnover and inflammatory variables during alendronate therapy in pediatric patients with rheumatic diseases. The Journal of rheumatology, 2002, Volume: 29, Issue:8 Topics: Adolescent; Alendronate; Anthropometry; Biomarkers; Bone Density; Bone Resorption; Child; Child, Pre	2002
Alendronate or alfacalcidol in glucocorticoid-induced osteoporosis. The New England journal of medicine, 2006, Aug-17, Volume: 355, Issue:7 Topics: Aged; Alendronate; Bone Density; Bone Density Conservation Agents; Double-Blind Method; Female; Gluc	2006

Article	Year
Early use of alendronate as a protective factor against the development of glucocorticoid-induced bone loss in childhood-onset rheumatic diseases: a cross-sectional study. Pediatric rheumatology online journal, 2018, Jun-18, Volume: 16, Issue:1 Topics: Adolescent; Adult; Alendronate; Bone Density; Bone Density Conservation Agents; Child; Cross-Section	2018
Prevention and treatment of glucocorticoid-induced osteoporosis. Current osteoporosis reports, 2007, Volume: 5, Issue:1 Topics: Alendronate; Bone Density Conservation Agents; Calcium; Cost-Benefit Analysis; Diphosphonates; Etidr	2007
Efficacy of intravenous alendronate for the treatment of glucocorticoid-induced osteoporosis in children with autoimmune diseases. Clinical rheumatology, 2008, Volume: 27, Issue:7 Topics: Alendronate; Antirheumatic Agents; Bone Density; Bone Density Conservation Agents; Bone Remodeling;	2008
Intravenous administration of alendronate counteracts the in vivo effects of glucocorticoids on bone remodeling. Calcified tissue international, 1996, Volume: 58, Issue:3 Topics: Adolescent; Alendronate; Bone Density; Bone Remodeling; Child; Female; Glucocorticoids; Humans; Inje	1996

alendronate and Rheumatic Diseases