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- Title
Effect of Teriparatide on Bone Remodeling and Density in Premenopausal Idiopathic Osteoporosis: A Phase II Trial.
- Authors
Cohen, Adi; Shiau, Stephanie; Nair, Nandini; Recker, Robert R.; Lappe, Joan M.; Dempster, David W.; Nickolas, Thomas L.; Hua Zhou; Agarwal, Sanchita; Kamanda-Kosseh, Mafo; Bucovsky, Mariana; Williams, John M.; McMahon, Donald J.; Stubby, Julie; Shane, Elizabeth; Zhou, Hua
- Abstract
<bold>Context: </bold>Premenopausal women with idiopathic osteoporosis (IOP) have abnormal skeletal microarchitecture and variable tissue-level bone formation rate (BFR).<bold>Objectives: </bold>Compare 6 months (M) of teriparatide versus placebo on areal bone mineral density (aBMD) by dual-energy x-ray absorptiometry (DXA), bone turnover markers (BTMs) and BFR at 3M by quadruple-labeled transiliac biopsy. Characterize 12M and 24M effects of teriparatide on aBMD and whether BTMs and BFR predict response.<bold>Design: </bold>6M phase 2 randomized controlled trial (RCT) followed by open extension.<bold>Setting: </bold>Tertiary referral centers.<bold>Patients: </bold>Premenopausal women with IOP.<bold>Interventions: </bold>A total of 41 women were randomized to either teriparatide 20 mcg (n = 28) or placebo (n = 13). After 6M, those on placebo switched to teriparatide for 24M; those on teriparatide continued for 18M.<bold>Main Outcome Measures: </bold>6M RCT: Between-group differences in lumbar spine (LS) aBMD (percent change from baseline), 3M BFR, and hypercalcemia. Open-label extension: Within-group change in LS aBMD over 12M and 24M. Secondary outcomes included aBMD change at other sites and relationship between BTMs, BFR, and changes in aBMD.<bold>Findings: </bold>Over 6M, LS aBMD increased by 5.5% (95% CI: 3.83, 7.19) in teriparatide and 1.5% (95% CI: -0.73, 3.83) in placebo (P = 0.007). There were increases in 3M BTMs, and BFR (cancellous and endocortical BFR: between-groups P = 0.004). Over 24M, teriparatide increased LS aBMD by 13.2% (95% CI: 10.3, 16.2), total hip by 5.2% (95% CI: 3.7, 6.7) and femoral neck by 5.0% (95% CI: 3.2, 6.7; all P ≤ 0.001). Serum N-terminal propeptides of procollagen type 1 (P1NP) and 3M endocortical BFR were moderately associated with LS aBMD response. Teriparatide was well-tolerated.<bold>Conclusions: </bold>Teriparatide increased BFR and formation markers and was associated with marked aBMD improvements in most premenopausal women (82%) with IOP.
- Subjects
BONE density; TERIPARATIDE; BONE remodeling; RADIAL bone; SOMATOMEDIN C; OSTEOPOROSIS; LUTEINIZING hormone releasing hormone
- Publication
Journal of Clinical Endocrinology & Metabolism, 2020, Vol 105, Issue 10, p1
- ISSN
0021-972X
- Publication type
journal article
- DOI
10.1210/clinem/dgaa489