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Effects of denosumab on bone mineral density and bone turnover in postmenopausal women.
J Clin Endocrinol Metab 2008; 93(6):2149-57JC

Abstract

CONTEXT

Denosumab is an investigational fully human monoclonal antibody against receptor activator of nuclear factor-kappaB ligand, a mediator of osteoclastogenesis and osteoclast survival.

OBJECTIVE

This study evaluated the ability of denosumab to increase bone mineral density (BMD) and decrease bone turnover markers (BTMs) in early and later postmenopausal women with low BMD.

DESIGN AND SETTING

This 2-yr randomized, double-blind, placebo-controlled study was conducted in North America.

PARTICIPANTS

Subjects included 332 postmenopausal women with lumbar spine BMD T-scores between -1.0 and -2.5.

INTERVENTIONS

SUBJECTS were randomly assigned to receive denosumab sc, 60 mg every 6 months, or placebo. Randomization was stratified by time since onset of menopause (< or =5 yr or > 5 yr).

MAIN OUTCOME MEASURES

The primary end point was the percent change in lumbar spine BMD by dual-energy x-ray absorptiometry at 24 months. Additional end points were percent change in volumetric BMD of the distal radius by quantitative computed tomography; percent change in BMD by dual-energy x-ray absorptiometry for the total hip, one-third radius, and total body; hip structural analysis; percent change in BTMs; and safety.

RESULTS

Denosumab significantly increased lumbar spine BMD, compared with placebo at 24 months (6.5 vs. -0.6%; P<0.0001) with similar results for both strata. Denosumab also produced significant increases in BMD at the total hip, one-third radius, and total body (P < 0.0001 vs. placebo); increased distal radius volumetric BMD (P < 0.01); improved hip structural analysis parameters; and significantly suppressed serum C-telopeptide, tartrate-resistant acid phosphatase-5b, and intact N-terminal propeptide of type 1 procollagen. The overall incidence of adverse events was similar between both study groups.

CONCLUSIONS

Twice-yearly denosumab increased BMD and decreased BTMs in early and later postmenopausal women.

Authors+Show Affiliations

Michigan Bone and Mineral Clinic, 22201 Moross Road, Detroit, MI 48236, USA. hgbone.md@att.netNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18381571

Citation

Bone, Henry G., et al. "Effects of Denosumab On Bone Mineral Density and Bone Turnover in Postmenopausal Women." The Journal of Clinical Endocrinology and Metabolism, vol. 93, no. 6, 2008, pp. 2149-57.
Bone HG, Bolognese MA, Yuen CK, et al. Effects of denosumab on bone mineral density and bone turnover in postmenopausal women. J Clin Endocrinol Metab. 2008;93(6):2149-57.
Bone, H. G., Bolognese, M. A., Yuen, C. K., Kendler, D. L., Wang, H., Liu, Y., & San Martin, J. (2008). Effects of denosumab on bone mineral density and bone turnover in postmenopausal women. The Journal of Clinical Endocrinology and Metabolism, 93(6), pp. 2149-57. doi:10.1210/jc.2007-2814.
Bone HG, et al. Effects of Denosumab On Bone Mineral Density and Bone Turnover in Postmenopausal Women. J Clin Endocrinol Metab. 2008;93(6):2149-57. PubMed PMID: 18381571.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effects of denosumab on bone mineral density and bone turnover in postmenopausal women. AU - Bone,Henry G, AU - Bolognese,Michael A, AU - Yuen,Chui Kin, AU - Kendler,David L, AU - Wang,Huei, AU - Liu,Yu, AU - San Martin,Javier, Y1 - 2008/04/01/ PY - 2008/4/3/pubmed PY - 2008/7/18/medline PY - 2008/4/3/entrez SP - 2149 EP - 57 JF - The Journal of clinical endocrinology and metabolism JO - J. Clin. Endocrinol. Metab. VL - 93 IS - 6 N2 - CONTEXT: Denosumab is an investigational fully human monoclonal antibody against receptor activator of nuclear factor-kappaB ligand, a mediator of osteoclastogenesis and osteoclast survival. OBJECTIVE: This study evaluated the ability of denosumab to increase bone mineral density (BMD) and decrease bone turnover markers (BTMs) in early and later postmenopausal women with low BMD. DESIGN AND SETTING: This 2-yr randomized, double-blind, placebo-controlled study was conducted in North America. PARTICIPANTS: Subjects included 332 postmenopausal women with lumbar spine BMD T-scores between -1.0 and -2.5. INTERVENTIONS: SUBJECTS were randomly assigned to receive denosumab sc, 60 mg every 6 months, or placebo. Randomization was stratified by time since onset of menopause (< or =5 yr or > 5 yr). MAIN OUTCOME MEASURES: The primary end point was the percent change in lumbar spine BMD by dual-energy x-ray absorptiometry at 24 months. Additional end points were percent change in volumetric BMD of the distal radius by quantitative computed tomography; percent change in BMD by dual-energy x-ray absorptiometry for the total hip, one-third radius, and total body; hip structural analysis; percent change in BTMs; and safety. RESULTS: Denosumab significantly increased lumbar spine BMD, compared with placebo at 24 months (6.5 vs. -0.6%; P<0.0001) with similar results for both strata. Denosumab also produced significant increases in BMD at the total hip, one-third radius, and total body (P < 0.0001 vs. placebo); increased distal radius volumetric BMD (P < 0.01); improved hip structural analysis parameters; and significantly suppressed serum C-telopeptide, tartrate-resistant acid phosphatase-5b, and intact N-terminal propeptide of type 1 procollagen. The overall incidence of adverse events was similar between both study groups. CONCLUSIONS: Twice-yearly denosumab increased BMD and decreased BTMs in early and later postmenopausal women. SN - 0021-972X UR - https://www.unboundmedicine.com/medline/citation/18381571/Effects_of_denosumab_on_bone_mineral_density_and_bone_turnover_in_postmenopausal_women_ L2 - https://academic.oup.com/jcem/article-lookup/doi/10.1210/jc.2007-2814 DB - PRIME DP - Unbound Medicine ER -