This 6-month randomized, placebo-controlled trial «Fazeli PK, Wang IS, Miller KK, ym. Teriparatide in...»1 at a clinical research center in USA included 21 adult women with AN: 10 (mean age+/-SEM, 47+/-2.7 years) treated with teriparatide (TPT) (20 microg s.c. once daily) and 11 (47.1+/-2.3 years) treated with placebo. BMD T-score ≤ -2.5 at any site was an inclusion criteria. Primary outcome measure was change in BMD of the spine and hip by dual-energy x-ray absorptiometry. Secondary outcome measures included changes in serum N-terminal propeptide of type 1 procollagen (P1NP), C-terminal collagen cross-links, sclerostin, and IGF-1 levels.
At 6 months, spine BMD increased significantly more with TPT (posteroanterior spine, 6.0 %+/-1.4 %; lateral spine, 10.5 %+/-2.5 %) compared with placebo (posteroanterior spine, 0.2 %+/-0.7 %, P <.01; lateral spine, -0.6 % +/- 1.0 %; P < .01). The results remained significant after controlling for baseline body mass index, P1NP, and IGF-1. Changes in femoral neck (P = 0.4) and total hip (P =0.8) BMD were comparable in both groups, as were changes in weight. Serum P1NP levels increased after 3 months of TPT treatment and remained at this higher level at 6 months, whereas P1NP levels were unchanged in the placebo group (P = .02). TPT was well-tolerated by all subjects.
This single-arm prospective Swiss study «Milos G, Moergeli H, Sob C, ym. Positive Effect of...»2 investigated the effect of Teriparatide 1–34 rh-PTH (TPT) 20 μg once daily sc for 24 months in 10 young women with anorexia nervosa (AN). Age range was 21-33 yr and in patients younger than 22 years epiphyseal closure was confirmed with forearm X-ray. Included patients had (i) very low bone mineral density (BMD) (defined as Z-Score < − 2.5 or T-Score < − 2.5 if available) in at least one of the assessed localizations (lumbar spine L1–L4, total hip, femoral neck) without any previous fragility fracture; or (ii) low BMD (defined as Z-Score < − 1.5 or T-Score < − 1.5 if available) in at least one of the assessed localizations (lumbar spine L1–L4, total hip, femoral neck) and at least one previous fragility fracture. Bone outcome was assessed after 12, 18, and 24 months.
After 24 months of TPT treatment, BMD improved by 13.5 % in the spine, 5.0 % in the femoral neck, and 4.0 % in the hip. Radius cortical bone density (− 2.6 %) and radius cortical thickness (− 6.4 %) decreased significantly, while in tibia there was no significant decrease. Neither in radius nor in tibia a significant change in trabecular bone parameters occurred. During the treatment, the patients' body weight did not increase significantly. Only mild side effects were observed, no serious adverse effects were observed.
General comment:
Teriparatide (rhPTH(1–34)) is an active fragment of human endogenous parathyroid hormone (PTH) (1–34). The duration of treatment is limited to two years due to osteosarcoma cases observed in animal studies. The treatment is contraindicated in individuals under 18 years of age and young adults whose epiphyseal plates have not yet fused. Teriparatide is contraindicated during pregnancy, with contraception to be considered. Indications include postmenopausal osteoporosis and glucocorticoid-induced osteoporosis; there is no indication for use in premenopausal patients with anorexia nervosa.