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Once-weekly oral alendronate 70 mg in patients with glucocorticoid-induced bone loss: a 12-month randomized, placebo-controlled clinical trial.
J Rheumatol. 2009 Aug; 36(8):1705-14.JR

Abstract

OBJECTIVE

Glucocorticoid-induced osteoporosis is the most common iatrogenic form of osteoporosis. We evaluated the efficacy and safety of once-weekly bisphosphonate therapy for prevention and treatment of bone loss in patients on glucocorticoid therapy.

METHODS

We conducted a 12-month, multicenter, randomized, double-blind, placebo-controlled trial with 114 and 59 patients in the treatment and placebo arms, respectively. Participants were stratified according to the duration of prior oral glucocorticoid therapy at randomization. Participants received alendronate 70 mg once weekly (ALN OW) or placebo; all received supplemental daily calcium (1000 mg) and 400 IU vitamin D. Clinical evaluations were performed at baseline, 3, 6, 9, and 12 months.

RESULTS

At 12 months, there was a significant mean percentage increase from baseline in the ALN OW group for lumbar spine (2.45%), trochanter (1.27%), total hip (0.75%), and total body (1.70%) bone mineral density (BMD). Comparing ALN OW versus placebo at 12 months, a significant treatment difference for the mean percentage change from baseline was observed for lumbar spine (treatment difference of 2.92%; p </= 0.001), trochanter (treatment difference 1.66%; p = 0.007), and total hip (treatment difference 1.19; p = 0.008) BMD. Biochemical markers of bone remodeling also showed significant mean percentage decreases from baseline.

CONCLUSION

Over 12 months ALN OW significantly increased lumbar spine, trochanter, total hip, and total body BMD compared with baseline among patients taking glucocorticoid therapy. A significant treatment difference versus placebo was observed at 12 months for the mean percentage change from baseline for lumbar spine, trochanter, and total hip.

Authors+Show Affiliations

Merck & Co., Inc., 126 E. Lincoln Ave., Rahway, NJ 07065. aubrey_stoch@merck.com.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

19487264

Citation

Stoch, S Aubrey, et al. "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, vol. 36, no. 8, 2009, pp. 1705-14.
Stoch SA, Saag KG, Greenwald M, et al. Once-weekly oral alendronate 70 mg in patients with glucocorticoid-induced bone loss: a 12-month randomized, placebo-controlled clinical trial. J Rheumatol. 2009;36(8):1705-14.
Stoch, S. A., Saag, K. G., Greenwald, M., Sebba, A. I., Cohen, S., Verbruggen, N., Giezek, H., West, J., & Schnitzer, T. J. (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, 36(8), 1705-14. https://doi.org/10.3899/jrheum.081207
Stoch SA, et al. Once-weekly Oral Alendronate 70 Mg in Patients With Glucocorticoid-induced Bone Loss: a 12-month Randomized, Placebo-controlled Clinical Trial. J Rheumatol. 2009;36(8):1705-14. PubMed PMID: 19487264.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Once-weekly oral alendronate 70 mg in patients with glucocorticoid-induced bone loss: a 12-month randomized, placebo-controlled clinical trial. AU - Stoch,S Aubrey, AU - Saag,Kenneth G, AU - Greenwald,Maria, AU - Sebba,Anthony I, AU - Cohen,Stanley, AU - Verbruggen,Nadia, AU - Giezek,Hilde, AU - West,Joseph, AU - Schnitzer,Thomas J, Y1 - 2009/06/01/ PY - 2009/6/3/entrez PY - 2009/6/3/pubmed PY - 2009/10/9/medline SP - 1705 EP - 14 JF - The Journal of rheumatology JO - J Rheumatol VL - 36 IS - 8 N2 - OBJECTIVE: Glucocorticoid-induced osteoporosis is the most common iatrogenic form of osteoporosis. We evaluated the efficacy and safety of once-weekly bisphosphonate therapy for prevention and treatment of bone loss in patients on glucocorticoid therapy. METHODS: We conducted a 12-month, multicenter, randomized, double-blind, placebo-controlled trial with 114 and 59 patients in the treatment and placebo arms, respectively. Participants were stratified according to the duration of prior oral glucocorticoid therapy at randomization. Participants received alendronate 70 mg once weekly (ALN OW) or placebo; all received supplemental daily calcium (1000 mg) and 400 IU vitamin D. Clinical evaluations were performed at baseline, 3, 6, 9, and 12 months. RESULTS: At 12 months, there was a significant mean percentage increase from baseline in the ALN OW group for lumbar spine (2.45%), trochanter (1.27%), total hip (0.75%), and total body (1.70%) bone mineral density (BMD). Comparing ALN OW versus placebo at 12 months, a significant treatment difference for the mean percentage change from baseline was observed for lumbar spine (treatment difference of 2.92%; p </= 0.001), trochanter (treatment difference 1.66%; p = 0.007), and total hip (treatment difference 1.19; p = 0.008) BMD. Biochemical markers of bone remodeling also showed significant mean percentage decreases from baseline. CONCLUSION: Over 12 months ALN OW significantly increased lumbar spine, trochanter, total hip, and total body BMD compared with baseline among patients taking glucocorticoid therapy. A significant treatment difference versus placebo was observed at 12 months for the mean percentage change from baseline for lumbar spine, trochanter, and total hip. SN - 0315-162X UR - https://www.unboundmedicine.com/medline/citation/19487264/Once_weekly_oral_alendronate_70_mg_in_patients_with_glucocorticoid_induced_bone_loss:_a_12_month_randomized_placebo_controlled_clinical_trial_ L2 - http://www.jrheum.org/cgi/pmidlookup?view=long&amp;pmid=19487264 DB - PRIME DP - Unbound Medicine ER -