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Two years of Denosumab and teriparatide administration in postmenopausal women with osteoporosis (The DATA Extension Study): a randomized controlled trial.
J Clin Endocrinol Metab. 2014 May; 99(5):1694-700.JC

Abstract

CONTEXT

Current osteoporosis medications increase bone mineral density (BMD) modestly and reduce, but do not eliminate, fracture risk. Attempts to improve efficacy by administering anabolic agents and bisphosphonates concomitantly have been unsuccessful. Conversely, 12 months of concomitant denosumab and teriparatide therapy increases BMD more than either drug alone.

OBJECTIVE

The purpose of this study was to determine whether 24 months of combined denosumab and teriparatide will increase hip and spine BMD more than either individual agent.

DESIGN

Preplanned continuation of the Denosumab and Teriparatide Administration (DATA) randomized controlled trial in which postmenopausal osteoporotic women received teriparatide (20 μg daily), denosumab (60 mg every 6 months), or both medications for 24 months.

PARTICIPANTS

Participants were 94 postmenopausal women with osteoporosis.

OUTCOME MEASURES

Lumbar spine, femoral neck, total hip, and distal radius BMD and serum markers of bone turnover were measured.

RESULTS

At 24 months, lumbar spine BMD increased more in the combination group (12.9 ± 5.0%) than in either the teriparatide (9.5 ± 5.9%, P = .01) or denosumab (8.3 ± 3.4%, P = .008) groups. Femoral neck BMD also increased more in the combination group (6.8 ± 3.6%) than in either the teriparatide (2.8 ± 3.9%, P = .003) or denosumab (4.1 ± 3.8%, P = .008) groups. Similarly, total hip BMD increased more in the combination group (6.3 ± 2.6%) than in the teriparatide (2.0 ± 3.0%) or denosumab (3.2 ± 2.5%) groups (P < .001 for both). Although spine and hip BMD continued to increase in the second year in all groups, these year 2 increases did not differ among groups. Serum C-telopeptide and N-terminal propeptide of type 1 procollagen were equally suppressed in the denosumab and combination groups, whereas osteocalcin decreased more in the denosumab group than in the combination group, a difference that persisted, but lessened, in the second year of therapy.

CONCLUSIONS

Two years of concomitant teriparatide and denosumab therapy increases BMD more than therapy with either medication alone and more than has been reported with any current therapy. The combination of these agents may prove to be an important treatment option in patients at high risk of fracture.

Authors+Show Affiliations

Department of Medicine, Endocrine Unit (B.Z.L., J.N.T., A.V.U., S.-A.M.B.-B., Y.Z., K.F., R.M.N.) and Biostatistics Center (H.L.), Massachusetts General Hospital, Boston, Massachusetts 02114.No 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
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

24517156

Citation

Leder, Benjamin Z., et al. "Two Years of Denosumab and Teriparatide Administration in Postmenopausal Women With Osteoporosis (The DATA Extension Study): a Randomized Controlled Trial." The Journal of Clinical Endocrinology and Metabolism, vol. 99, no. 5, 2014, pp. 1694-700.
Leder BZ, Tsai JN, Uihlein AV, et al. Two years of Denosumab and teriparatide administration in postmenopausal women with osteoporosis (The DATA Extension Study): a randomized controlled trial. J Clin Endocrinol Metab. 2014;99(5):1694-700.
Leder, B. Z., Tsai, J. N., Uihlein, A. V., Burnett-Bowie, S. A., Zhu, Y., Foley, K., Lee, H., & Neer, R. M. (2014). Two years of Denosumab and teriparatide administration in postmenopausal women with osteoporosis (The DATA Extension Study): a randomized controlled trial. The Journal of Clinical Endocrinology and Metabolism, 99(5), 1694-700. https://doi.org/10.1210/jc.2013-4440
Leder BZ, et al. Two Years of Denosumab and Teriparatide Administration in Postmenopausal Women With Osteoporosis (The DATA Extension Study): a Randomized Controlled Trial. J Clin Endocrinol Metab. 2014;99(5):1694-700. PubMed PMID: 24517156.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Two years of Denosumab and teriparatide administration in postmenopausal women with osteoporosis (The DATA Extension Study): a randomized controlled trial. AU - Leder,Benjamin Z, AU - Tsai,Joy N, AU - Uihlein,Alexander V, AU - Burnett-Bowie,Sherri-Ann M, AU - Zhu,Yuli, AU - Foley,Katelyn, AU - Lee,Hang, AU - Neer,Robert M, Y1 - 2014/02/11/ PY - 2014/2/13/entrez PY - 2014/2/13/pubmed PY - 2014/7/11/medline SP - 1694 EP - 700 JF - The Journal of clinical endocrinology and metabolism JO - J Clin Endocrinol Metab VL - 99 IS - 5 N2 - CONTEXT: Current osteoporosis medications increase bone mineral density (BMD) modestly and reduce, but do not eliminate, fracture risk. Attempts to improve efficacy by administering anabolic agents and bisphosphonates concomitantly have been unsuccessful. Conversely, 12 months of concomitant denosumab and teriparatide therapy increases BMD more than either drug alone. OBJECTIVE: The purpose of this study was to determine whether 24 months of combined denosumab and teriparatide will increase hip and spine BMD more than either individual agent. DESIGN: Preplanned continuation of the Denosumab and Teriparatide Administration (DATA) randomized controlled trial in which postmenopausal osteoporotic women received teriparatide (20 μg daily), denosumab (60 mg every 6 months), or both medications for 24 months. PARTICIPANTS: Participants were 94 postmenopausal women with osteoporosis. OUTCOME MEASURES: Lumbar spine, femoral neck, total hip, and distal radius BMD and serum markers of bone turnover were measured. RESULTS: At 24 months, lumbar spine BMD increased more in the combination group (12.9 ± 5.0%) than in either the teriparatide (9.5 ± 5.9%, P = .01) or denosumab (8.3 ± 3.4%, P = .008) groups. Femoral neck BMD also increased more in the combination group (6.8 ± 3.6%) than in either the teriparatide (2.8 ± 3.9%, P = .003) or denosumab (4.1 ± 3.8%, P = .008) groups. Similarly, total hip BMD increased more in the combination group (6.3 ± 2.6%) than in the teriparatide (2.0 ± 3.0%) or denosumab (3.2 ± 2.5%) groups (P < .001 for both). Although spine and hip BMD continued to increase in the second year in all groups, these year 2 increases did not differ among groups. Serum C-telopeptide and N-terminal propeptide of type 1 procollagen were equally suppressed in the denosumab and combination groups, whereas osteocalcin decreased more in the denosumab group than in the combination group, a difference that persisted, but lessened, in the second year of therapy. CONCLUSIONS: Two years of concomitant teriparatide and denosumab therapy increases BMD more than therapy with either medication alone and more than has been reported with any current therapy. The combination of these agents may prove to be an important treatment option in patients at high risk of fracture. SN - 1945-7197 UR - https://www.unboundmedicine.com/medline/citation/24517156/Two_years_of_Denosumab_and_teriparatide_administration_in_postmenopausal_women_with_osteoporosis__The_DATA_Extension_Study_:_a_randomized_controlled_trial_ L2 - https://academic.oup.com/jcem/article-lookup/doi/10.1210/jc.2013-4440 DB - PRIME DP - Unbound Medicine ER -