Randomised controlled study of effect of parathyroid hormone on vertebral-bone mass and fracture incidence among postmenopausal women on oestrogen with osteoporosis

Small increases in bone mass are commonly seen with existing treatments for osteoporosis, which reduce bone remodelling and primarily prevent bone loss. Since these drugs reduce but do not eliminate risk of fractures, an anabolic agent that would increase bone mass and potentially cure the underlyin...

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Veröffentlicht in:The Lancet (British edition) 1997-08, Vol.350 (9077), p.550-555
Hauptverfasser: Lindsay, Robert, Nieves, Jeri, Formica, Carmelo, Henneman, Emily, Woelfert, Lillian, Shen, Victor, Dempster, David, Cosman, Felicia
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container_end_page 555
container_issue 9077
container_start_page 550
container_title The Lancet (British edition)
container_volume 350
creator Lindsay, Robert
Nieves, Jeri
Formica, Carmelo
Henneman, Emily
Woelfert, Lillian
Shen, Victor
Dempster, David
Cosman, Felicia
description Small increases in bone mass are commonly seen with existing treatments for osteoporosis, which reduce bone remodelling and primarily prevent bone loss. Since these drugs reduce but do not eliminate risk of fractures, an anabolic agent that would increase bone mass and potentially cure the underlying skeletal problem is needed. We did a 3-year randomised controlled trial to find out the effects of 1–34 human parathyroid hormone (hPTH [1–34], 400 U/25 μg daily subcutaneously) in postmenopausal women with osteoporosis taking hormone-replacement therapy (n=17). The controls were women taking hormone-replacement therapy only (n=17). The primary outcome was bone-mineral density of the lumbar vertebrae, with bone-mineral density at other sites and vertebral fractures as secondary endpoints. Patients taking hormone-replacement therapy and PTH (1–34) had continuous increase in vertebral bone-mineral density during the 3 years, whereas there was no significant change in the control group. The total increase in vertebral bone-mineral density was 13·0% (p
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Since these drugs reduce but do not eliminate risk of fractures, an anabolic agent that would increase bone mass and potentially cure the underlying skeletal problem is needed. We did a 3-year randomised controlled trial to find out the effects of 1–34 human parathyroid hormone (hPTH [1–34], 400 U/25 μg daily subcutaneously) in postmenopausal women with osteoporosis taking hormone-replacement therapy (n=17). The controls were women taking hormone-replacement therapy only (n=17). The primary outcome was bone-mineral density of the lumbar vertebrae, with bone-mineral density at other sites and vertebral fractures as secondary endpoints. Patients taking hormone-replacement therapy and PTH (1–34) had continuous increase in vertebral bone-mineral density during the 3 years, whereas there was no significant change in the control group. The total increase in vertebral bone-mineral density was 13·0% (p&lt;0·001); 2·7% at the hip (p=0·05); and 8·0% in total-body bone mineral (p=0·002). No loss of bone mass was found at any skeletal site. Increased bone mass was associated with a reduction in the rate of vertebral fractures, which was significant when fractures were taken as a 15% reduction in vertebral height (p=0·04). During the first 6 months of treatment, serum osteocalcin concentration, which reflects bone formation, increased by more than 55%, whereas excretion of crosslinked n-telopeptide, which reflects bone resorption, increased by only 20%, which suggests some uncoupling of bone formation and resorption. By 6 months, there were similar increases in both markers, which gradually returned towards baseline as the study progressed. Vertebral bone-mineral density increased most during the first year of PTH treatment. We found that PTH has a pronouned anabolic effect on the central skeleton in patients on hormone-replacement therapy. PTH also increases total-body bone mineral, with no detrimental effects at any skeletal site. 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The increased vertebral mass was associated with a reduced rate of vertebral fracture, despite increased bone turnover. Bone-mass changes may be consistent with a reduction in all osteoporotic fractures. If confirmed in larger studies, these data have important implications for the treatment of postmenopausal osteoporosis.</abstract><cop>London</cop><pub>Elsevier Ltd</pub><pmid>9284777</pmid><doi>10.1016/S0140-6736(97)02342-8</doi><tpages>6</tpages><oa>free_for_read</oa></addata></record>
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subjects Absorptiometry, Photon
Aged
Biological and medical sciences
Biomarkers - analysis
Bone Density - drug effects
Bones
Drug therapy
Estrogen Replacement Therapy
Estrogens - therapeutic use
Female
Fractures, Bone - epidemiology
Fractures, Bone - prevention & control
Hormones
Hormones. Endocrine system
Humans
Incidence
Medical sciences
Menopause
Middle Aged
Osteoporosis
Osteoporosis, Postmenopausal - drug therapy
Osteoporosis, Postmenopausal - physiopathology
Pharmacology. Drug treatments
Postmenopause
Spine
Teriparatide - pharmacology
Teriparatide - therapeutic use
Women
title Randomised controlled study of effect of parathyroid hormone on vertebral-bone mass and fracture incidence among postmenopausal women on oestrogen with osteoporosis
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