Treatment with parathyroid peptides and estrogen replacement for severe postmenopausal vertebral osteoporosis: prediction of long-term responses in spine and femur

Abstract

Fifteen women with severe vertebral osteoporosis were treated with daily parathyroid peptide (hPTH) plus hormone-replacement co-therapy (HRT) for 1 year. Eight other patients were randomized to HRT alone. Co-therapy with hPTH and HRT resulted in an impressive mean treatment response at the spine (dual-energy X-ray absorptiometry DXA) 15% above baseline; P < 0.015 compared with the HRT group) at 2 years, while at the proximal femur and radius there were smaller increases. hPTH co-therapy led to a significantly positive metabolic calcium balance at 1 year (by 2.13 mmol Ca/day, equivalent to a 5% annual increment in total body calcium; P = 0.015). The magnitude of the lumbar spine DXA response at 2 years depended statistically on the increase in bone formation rate, measured with 85Sr (r2 adjusted 0.48; P < 0.005) and patients with a large spine DXA response had larger calcium balance improvements (P < 0.03). Plasma osteocalcin changes tracked closely with increases in bone formation rate (r2 = 0.87). In seven patients treated throughout with HRT alone, and in eight hPTH-treated patients (three of whom switched to bisphosphonate therapy at year 4). DXA spine changes seen in years 3-5 were minimal, with no evidence of a statistically significant difference between groups. It is concluded that hPTH or comparable PTH receptor activators remain the most promising anabolic treatment for osteoporosis currently under clinical evaluation and a 6- or 12-month measurement of bone formation or a marker predicts the 2-5 year bone density outcome. Post-hPTH treatment, loss of bone appeared preventable with anti-resorptive therapy.

Parathyroid Hormone for Treatment of Osteoporosis

“…Outcomes of the same trial were sometimes reported in separate articles, and some articles were continuations of results of earlier trials. [16][17][18][19][20][21][22][23][24][25][26] The number of subjects per trial ranged from 9 35 to 1637. 28 Treatment duration ranged from 6 weeks 27 to 3 years.…”

“…Kurland et al, 32 2000 Numbers of radiographically detected vertebral fractures too small to establish significance. Reeve et al, 35 bar BMD. This was observed when PTH was given alone or with sequential calcitonin, HRT, calcitriol, or alendronate.…”

“…Specifically, osteoporosis was postmenopausal osteoporosis, 16,17,20,21,[27][28][29][30][31]34,35 idiopathic male osteoporosis, 16,17,32 or glucocorticoid-induced osteoporosis. [22][23][24] These 3 clinical scenarios are individually reviewed herein.…”

A systematic review and economic evaluation of alendronate, etidronate, risedronate, raloxifene and teriparatide for the prevention and treatment of postmenopausal osteoporosis

“…Quantity and quality of research available: teriparatide in postmenopausal osteoporosis or osteopenia Three RCTs 94,[148][149][150][151] were identified that compared teriparatide with another of the interventions or comparators reviewed in this report in women with postmenopausal osteoporosis or osteopenia, and that reported fracture outcomes (for details, see Appendix 10, Tables 160 and 161). A fourth study, 152 which compared teriparatide plus HRT with HRT alone, was excluded because it was not truly randomised. It had originally been intended to recruit 40 women to this trial but, after 11 women had been recruited and randomised, the new owners of the company that supplied the teriparatide would only supply it to those women who had already been randomised at that time.…”

Recombinant human parathyroid hormone

“…We also need to know whether antiresorptive treatment should be started when parathyroid hormone treatment is stopped, to prevent subsequent loss of bone. 13 14…”