دورية أكاديمية
أعرض في EDS

Denosumab and teriparatide transitions in postmenopausal osteoporosis (the DATA-Switch study): extension of a randomised controlled trial.

التفاصيل البيبلوغرافية
العنوان: Denosumab and teriparatide transitions in postmenopausal osteoporosis (the DATA-Switch study): extension of a randomised controlled trial.
المؤلفون: Leder BZ; Department of Medicine, Endocrine Unit, Massachusetts General Hospital, Boston, MA, USA. Electronic address: bzleder@partners.org., Tsai JN; Department of Medicine, Endocrine Unit, Massachusetts General Hospital, Boston, MA, USA., Uihlein AV; Department of Medicine, Endocrine Unit, Massachusetts General Hospital, Boston, MA, USA., Wallace PM; Department of Medicine, Endocrine Unit, Massachusetts General Hospital, Boston, MA, USA., Lee H; Biostatistics Center, Massachusetts General Hospital, Boston, MA, USA., Neer RM; Department of Medicine, Endocrine Unit, Massachusetts General Hospital, Boston, MA, USA., Burnett-Bowie SA; Department of Medicine, Endocrine Unit, Massachusetts General Hospital, Boston, MA, USA.
المصدر: Lancet (London, England) [Lancet] 2015 Sep 19; Vol. 386 (9999), pp. 1147-55. Date of Electronic Publication: 2015 Jul 02.
نوع المنشور: Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't
اللغة: English
بيانات الدورية: Publisher: Elsevier Country of Publication: England NLM ID: 2985213R Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1474-547X (Electronic) Linking ISSN: 01406736 NLM ISO Abbreviation: Lancet Subsets: MEDLINE
أسماء مطبوعة: Publication: 2004- : London : Elsevier
Original Publication: London : J. Onwhyn
مواضيع طبية MeSH: Antibodies, Monoclonal, Humanized/*administration & dosage , Bone Density Conservation Agents/*administration & dosage , Osteoporosis, Postmenopausal/*drug therapy , Teriparatide/*administration & dosage, Aged ; Antibodies, Monoclonal, Humanized/adverse effects ; Antibodies, Monoclonal, Humanized/therapeutic use ; Bone Density/drug effects ; Bone Density Conservation Agents/adverse effects ; Bone Density Conservation Agents/therapeutic use ; Denosumab ; Drug Administration Schedule ; Drug Substitution ; Drug Therapy, Combination ; Female ; Follow-Up Studies ; Humans ; Middle Aged ; Osteoporosis, Postmenopausal/physiopathology ; Single-Blind Method ; Teriparatide/adverse effects ; Teriparatide/therapeutic use
مستخلص: Background: Unlike most chronic diseases, osteoporosis treatments are generally limited to a single drug at a fixed dose and frequency. Nonetheless, no approved therapy is able to restore skeletal integrity in most osteoporotic patients and the long-term use of osteoporosis drugs is controversial. Thus, many patients are treated with the sequential use of two or more therapies. The DATA study showed that combined teriparatide and denosumab increased bone mineral density more than either drug alone. Discontinuing teriparatide and denosumab, however, results in rapidly declining bone mineral density. In this DATA-Switch study, we aimed to assess the changes in bone mineral density in postmenopausal osteoporotic women who transitioned between treatments.
Methods: This randomised controlled trial (DATA-Switch) is a preplanned extension of the denosumab and teriparatide administration study (DATA), in which 94 postmenopausal osteoporotic women were randomly assigned to receive 24 months of teriparatide (20 mg daily), denosumab (60 mg every 6 months), or both drugs. In DATA-Switch, women originally assigned to teriparatide received denosumab (teriparatide to denosumab group), those originally assigned to denosumab received teriparatide (denosumab to teriparatide group), and those originally assigned to both received an additional 24 months of denosumab alone (combination to denosumab group). Bone mineral density at the spine, hip, and wrist were measured 6 months, 12 months, 18 months, and 24 months after the drug transitions as were biochemical markers of bone turnover. The primary endpoint was the percent change in posterior-anterior spine bone mineral density over 4 years. Between-group changes were assessed by one-way analysis of variance in our modified intention-to-treat population. This study is registered with ClinicalTrials.gov, number NCT00926380.
Findings: Between Sept 27, 2011, and Jan 28, 2013, eligible women from the DATA study were enrolled into DATA-Switch. Of 83 potential enrollees from the DATA study, 77 completed at least one post-baseline visit. After 48 months, the primary outcome of mean spine bone mineral density increased by 18·3% (95% CI 14·9-21·8) in 27 women in the teriparatide to denosumab group, 14·0% (10·9-17·2) in 27 women the denosumab to teriparatide group, and 16·0% (14·0-18·0) in 23 women in the combination to denosumab group, although this increase did not differ significantly between groups (for between-group comparisons, p=0·13 for the teriparatide to denosumab group vs the denosumab to teriparatide group, p=0·30 for the teriparatide to denosumab group vs the combination to denosumab group, and p=0·41 for the denosumab to teriparatide group vs the combination to denosumab group). For the bone mineral density secondary outcomes, total hip bone mineral density increased more in the teriparatide to denosumab group (6·6% [95% CI 5·3-7·9]) than in the denosumab to teriparatide group (2·8% [1·3-4·2], p=0·0002), but had the greatest increase in the combination to denosumab group (8·6% [7·1-10·0]; p=0·0446 vs the teriparatide to denosumab group, p<0·0001 vs the denosumab to teriparatide group). Similarly, femoral neck bone mineral density increased more in the teriparatide to denosumab group (8·3% [95% CI 6·1-10·5]) and the combination to denosumab group (9·1% [6·1-12·0]) than in the denosumab to teriparatide group (4·9% [2·2-7·5]; p=0·0447 for teriparatide to denosumab vs denosumab to teriparatide, p=0·0336 for combination to denosumab vs denosumab to teriparatide). Differences between the combination to denosumab group and the teriparatide to denosumab group did not differ significantly (p=0·67). After 48 months, radius bone mineral density was unchanged in the teriparatide to denosumab group (0·0% [95% CI -1·3 to 1·4]), whereas it decreased by -1·8% (-5·0 to 1·3) in the denosumab to teriparatide group, and increased by 2·8% (1·2-4·4) in the combination to denosumab group (p=0·0075 for the teriparatide to denosumab group vs the combination to denosumab group; p=0·0099 for the denosumab to teriparatide group vs the combination to denosumab group). One participant in the denosumab to teriparatide group had nephrolithiasis, classified as being possibly related to treatment.
Interpretation: In postmenopausal osteoporotic women switching from teriparatide to denosumab, bone mineral density continued to increase, whereas switching from denosumab to teriparatide results in progressive or transient bone loss. These results should be considered when choosing the initial and subsequent management of postmenopausal osteoporotic patients.
Funding: Amgen, Eli Lilly, and National Institutes of Health.
(Copyright © 2015 Elsevier Ltd. All rights reserved.)
التعليقات: Comment in: Lancet. 2015 Sep 19;386(9999):1116-8. (PMID: 26144907)
Comment in: Nat Rev Endocrinol. 2015 Oct;11(10):570-2. (PMID: 26260144)
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معلومات مُعتمدة: K24 AR067847 United States AR NIAMS NIH HHS; UL1 RR025758 United States RR NCRR NIH HHS; ULI RR025758 United States RR NCRR NIH HHS
سلسلة جزيئية: ClinicalTrials.gov NCT00926380
المشرفين على المادة: 0 (Antibodies, Monoclonal, Humanized)
0 (Bone Density Conservation Agents)
10T9CSU89I (Teriparatide)
4EQZ6YO2HI (Denosumab)
تواريخ الأحداث: Date Created: 20150707 Date Completed: 20151109 Latest Revision: 20220409
رمز التحديث: 20240628
مُعرف محوري في PubMed: PMC4620731
DOI: 10.1016/S0140-6736(15)61120-5
PMID: 26144908
قاعدة البيانات: MEDLINE
الوصف
تدمد:1474-547X
DOI:10.1016/S0140-6736(15)61120-5