Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

Teriparatide can be considered in premenopausal women with idiopathic osteoporosis

Publish date:: October 21, 2020

Key clinical point: Teriparatide improves bone formation rate (BFR), bone turnover markers, and spine and hip bone density in premenopausal women with idiopathic osteoporosis (IOP).

Major finding: At 6 months, teriparatide significantly increased lumbar spine (LS) areal bone mineral density (aBMD) vs placebo (percentage change: 5.51% vs. 1.55%; P = .007). At 24 months, teriparatide significantly increased aBMD of LS, total hip, and femoral neck (percentage change: 13.2%, 5.2%, and 5.0%, respectively; P ≤. 001 for all). Cancellous and intracortical BFR increased 3.3-fold (P ≤. 001) and 1.9-fold (P ≤. 001), respectively, in the teriparatide group with no change in placebo group. Serum N-terminal propeptides of procollagen type 1, osteocalcin, and C-telopeptide increased significantly by 3 months with teriparatide treatment.

Study details: The data come from a phase 2 trial of 41 premenopausal women with IOP who were randomly assigned to either teriparatide 20 mcg (n = 28) or placebo (n = 13). After 6 months, placebo group was switched to teriparatide for 24 months, and the teriparatide group continued the drug for 18 months.

Disclosures: The study was supported by the United States Food and Drug Administration Orphan Products Clinical Trials Grants Program. A Cohen, E Shane, RR Recker, and JM Lappe received research support from Amgen and Eli Lilly. DW Dempster received research support and consulting fees from Amgen, Eli Lilly, and Radius Health.

Commentary

“Postmenopausal osteoporosis (PMO) is characterized by low bone mineral mass, disruption of bone microarchitecture, and increase risk of fractures. Teriparatide is a PTH analog that promotes bone formation and decreases risk for fragility fractures. In this phase II clinical trial, 41 women with PMO were randomized to either teriparatide 20 mcg (n = 28) or placebo (n = 13) for 6 months. After 6 months, women in the placebo arm switched to teriparatide for 24 months and those in the teriparatide arm continued on teriparatide for an additional 18 months. Quadruple-labeled transiliac biopsies were performed to assess bone formation rate and bone turnover markers (N-terminal propeptides of procollagen type 1, osteocalcin, and C-telopeptide) were measured at 3 months. At 6 months, there were statistically significant differences in the lumbar spine areal bone mineral density (BMD) between the two groups. At 24 months, lumbar spine BMD was 13% higher and hip/femoral neck BMD were 5% higher compared to baseline. In addition, bone formation rate was higher in the teriparatide group, but remained unchanged in the placebo group at 3 months. Bone turnover markers were higher in the teriparatide group compared to placebo group. These study shows that teriparatide quickly improves BMD at spine and bone formation rate in women with PMO and adds to the body of data that supports use of anabolics early in the course of osteoporosis to promote improved skeletal parameters.”