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Bisphosphonates and glucocorticoid osteoporosis in men: results of a randomized controlled trial comparing zoledronic acid with risedronate.
Bone. 2012 Jan; 50(1):289-95.BONE

Abstract

BACKGROUND

We studied 265 men (mean age 56.4 years; range 18-83 years), among patients enrolled in two arms of a double-blind, 1-year study comparing the effects of zoledronic acid (ZOL) with risedronate (RIS) in patients either commencing (prednisolone 7.5 mg/day or equivalent) (prevention arm, n=88) or continuing glucocorticoid therapy (treatment arm, n=177).

METHODS

Patients received either a single ZOL 5 mg infusion or RIS 5 mg oral daily at randomization, along with calcium (1000 mg) and vitamin D (400-1200 IU). Primary endpoint: difference in percentage change from baseline in bone mineral density (BMD) at the lumbar spine (LS) at 12 months. Secondary endpoints: percentage changes in BMD at total hip (TH) and femoral neck (FN), relative changes in bone turnover markers (β-CTx and P1NP), and overall safety.

FINDINGS

In the treatment subpopulation, ZOL increased LS BMD by 4.7% vs. 3.3% for RIS and at TH the percentage changes were 1.8% vs. 0.2%, respectively. In the prevention subpopulation, bone loss was prevented by both treatments. At LS the percentage changes were 2.5% vs. -0.2% for ZOL vs. RIS and at TH the percentage changes were 1.1% vs. -0.4%, respectively. ZOL significantly increased lumbar spine BMD more than RIS at Month 12 in both the prevention population (p=0.0024) and the treatment subpopulation (p=0.0232) in men. In the treatment subpopulation, ZOL demonstrated a significantly greater reduction in serum β-CTx and P1NP relative to RIS at all time-points. In the prevention subpopulation, ZOL significantly reduced β-CTx at all time-points, and P1NP at Month 3 (p=0.0297) only. Both treatments were well tolerated in men, albeit with a higher incidence of influenza-like illness and pyrexia events post-infusion with ZOL.

INTERPRETATION

Once-yearly ZOL preserves or increases BMD within 1 year to a greater extent than daily RIS in men receiving glucocorticoid therapy.

Authors+Show Affiliations

University of Sydney, Sydney, NSW, Australia. sambrook@med.usyd.edu.auNo 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
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22061864

Citation

Sambrook, Philip N., et al. "Bisphosphonates and Glucocorticoid Osteoporosis in Men: Results of a Randomized Controlled Trial Comparing Zoledronic Acid With Risedronate." Bone, vol. 50, no. 1, 2012, pp. 289-95.
Sambrook PN, Roux C, Devogelaer JP, et al. Bisphosphonates and glucocorticoid osteoporosis in men: results of a randomized controlled trial comparing zoledronic acid with risedronate. Bone. 2012;50(1):289-95.
Sambrook, P. N., Roux, C., Devogelaer, J. P., Saag, K., Lau, C. S., Reginster, J. Y., Bucci-Rechtweg, C., Su, G., & Reid, D. M. (2012). Bisphosphonates and glucocorticoid osteoporosis in men: results of a randomized controlled trial comparing zoledronic acid with risedronate. Bone, 50(1), 289-95. https://doi.org/10.1016/j.bone.2011.10.024
Sambrook PN, et al. Bisphosphonates and Glucocorticoid Osteoporosis in Men: Results of a Randomized Controlled Trial Comparing Zoledronic Acid With Risedronate. Bone. 2012;50(1):289-95. PubMed PMID: 22061864.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Bisphosphonates and glucocorticoid osteoporosis in men: results of a randomized controlled trial comparing zoledronic acid with risedronate. AU - Sambrook,Philip N, AU - Roux,Christian, AU - Devogelaer,Jean-Pierre, AU - Saag,Kenneth, AU - Lau,Chak-Sing, AU - Reginster,Jean-Yves, AU - Bucci-Rechtweg,Christina, AU - Su,Guoqin, AU - Reid,David M, Y1 - 2011/10/29/ PY - 2011/06/22/received PY - 2011/09/15/revised PY - 2011/10/24/accepted PY - 2011/11/9/entrez PY - 2011/11/9/pubmed PY - 2012/4/13/medline SP - 289 EP - 95 JF - Bone JO - Bone VL - 50 IS - 1 N2 - BACKGROUND: We studied 265 men (mean age 56.4 years; range 18-83 years), among patients enrolled in two arms of a double-blind, 1-year study comparing the effects of zoledronic acid (ZOL) with risedronate (RIS) in patients either commencing (prednisolone 7.5 mg/day or equivalent) (prevention arm, n=88) or continuing glucocorticoid therapy (treatment arm, n=177). METHODS: Patients received either a single ZOL 5 mg infusion or RIS 5 mg oral daily at randomization, along with calcium (1000 mg) and vitamin D (400-1200 IU). Primary endpoint: difference in percentage change from baseline in bone mineral density (BMD) at the lumbar spine (LS) at 12 months. Secondary endpoints: percentage changes in BMD at total hip (TH) and femoral neck (FN), relative changes in bone turnover markers (β-CTx and P1NP), and overall safety. FINDINGS: In the treatment subpopulation, ZOL increased LS BMD by 4.7% vs. 3.3% for RIS and at TH the percentage changes were 1.8% vs. 0.2%, respectively. In the prevention subpopulation, bone loss was prevented by both treatments. At LS the percentage changes were 2.5% vs. -0.2% for ZOL vs. RIS and at TH the percentage changes were 1.1% vs. -0.4%, respectively. ZOL significantly increased lumbar spine BMD more than RIS at Month 12 in both the prevention population (p=0.0024) and the treatment subpopulation (p=0.0232) in men. In the treatment subpopulation, ZOL demonstrated a significantly greater reduction in serum β-CTx and P1NP relative to RIS at all time-points. In the prevention subpopulation, ZOL significantly reduced β-CTx at all time-points, and P1NP at Month 3 (p=0.0297) only. Both treatments were well tolerated in men, albeit with a higher incidence of influenza-like illness and pyrexia events post-infusion with ZOL. INTERPRETATION: Once-yearly ZOL preserves or increases BMD within 1 year to a greater extent than daily RIS in men receiving glucocorticoid therapy. SN - 1873-2763 UR - https://www.unboundmedicine.com/medline/citation/22061864/Bisphosphonates_and_glucocorticoid_osteoporosis_in_men:_results_of_a_randomized_controlled_trial_comparing_zoledronic_acid_with_risedronate_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S8756-3282(11)01322-6 DB - PRIME DP - Unbound Medicine ER -