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

Lindsay, Robert; Nieves, Jeri W.; Formica, Carmelo; Henneman, Emily; Woelfert, Lillian; Shen, Victor; Dempster, David W.; Cosman, Felicia

doi:10.1016/s0140-6736(97)02342-8

Cited by 709 publications

(462 citation statements)

References 21 publications

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“…(15) There is a striking disparity between the present findings and the results of bone densitometry studies of the effects of teriparatide treatment at the spine and proximal femur. (5,(35)(36)(37)(38) DXA scan results from the present study are consistent with earlier findings from clinical trials that showed large increases in lumbar spine BMD with more modest changes at the hip. (5,35,36) Results of total-body DXA scans, which are sensitive to the treatment effects on cortical bone across the whole skeleton, also showed only a small increase in total body bone mineral content.…”

Section: Discussionsupporting

confidence: 91%

“…(5,(35)(36)(37)(38) DXA scan results from the present study are consistent with earlier findings from clinical trials that showed large increases in lumbar spine BMD with more modest changes at the hip. (5,35,36) Results of total-body DXA scans, which are sensitive to the treatment effects on cortical bone across the whole skeleton, also showed only a small increase in total body bone mineral content. (5,35) Studies using quantitative computed tomography (QCT) are a particularly sensitive means of comparing the effects of teriparatide treatment on BMD at trabecular and cortical bone sites in the spine and hip.…”

Section: Discussionsupporting

confidence: 91%

“…(5,35,36) Results of total-body DXA scans, which are sensitive to the treatment effects on cortical bone across the whole skeleton, also showed only a small increase in total body bone mineral content. (5,35) Studies using quantitative computed tomography (QCT) are a particularly sensitive means of comparing the effects of teriparatide treatment on BMD at trabecular and cortical bone sites in the spine and hip. The results show a large treatment effect on trabecular bone at the spine, a smaller effect on trabecular bone at the hip, and modest or absent effects on BMD in cortical bone, especially the hip.…”

Section: Discussionmentioning

confidence: 99%

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Differential effects of teriparatide on regional bone formation using 18F-fluoride positron emission tomography

Frost

Siddique

Blake

et al. 2010

Journal of Bone and Mineral Research

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Teriparatide increases skeletal mass, bone turnover markers, and bone strength, but local effects on bone tissue may vary between skeletal sites. We used positron emission tomography (PET) to study 18 F-fluoride plasma clearance (K i ) at the spine and standardized uptake values (SUVs) at the spine, pelvis, total hip, and femoral shaft in 18 postmenopausal women with osteoporosis. Subjects underwent a 1-hour dynamic scan of the lumbar spine and a 10-minute static scan of the pelvis and femurs at baseline and after 6 months of treatment with 20 mg/day teriparatide. Blood samples were taken to derive the arterial input function and lumbar spine K i values evaluated using a three-compartment model. SUVs were calculated for the spine, pelvis, total hip, and femoral shaft. After 6 months treatment with teriparatide, spine K i values increased by 24% (p ¼ .0003), while other model parameters were unchanged except for the fraction of tracer going to bone mineral (k 3 /[k 2 þ k 3 ]), which increased by 23% (p ¼ .0006). In contrast to K i , spine SUVs increased by only 3% (p ¼ .84). The discrepancy between changes in K i and SUVs was explained by a 20% decrease in 18 F À plasma concentration. SUVs increased by 37% at the femoral shaft (p ¼ .0019), 20% at the total hip (p ¼ .032), and 11% at the pelvis (p ¼ .070). Changes in bone turnover markers and BMD were consistent with previous trials. We conclude that the changes in bone formation rate during teriparatide treatment as measured by 18 F À PET differ at different skeletal sites, with larger increases in cortical bone than at trabecular sites. ß

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Section: Discussionsupporting

confidence: 91%

Section: Discussionsupporting

confidence: 91%

Section: Discussionmentioning

confidence: 99%

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Differential effects of teriparatide on regional bone formation using 18F-fluoride positron emission tomography

Frost

Siddique

Blake

et al. 2010

Journal of Bone and Mineral Research

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“…The early timing of the DXA scan limits any useful comparison with other studies, but results from the pivotal fracture trials of TPT showed that changes in areal BMD are greatest at the lumbar spine, with only relatively modest gains or even loss in BMD being seen at the hip. (35)(36)(37)(38) As observed in an earlier 6-month study of the effect of TPT treatment at the lumbar spine, (23) there was a disparity between the changes in regional bone formation and results from studies of the effects of teriparatide on BMD at the spine and hip. (35)(36)(37)(38)(39) The increases in BMD at the hip are relatively modest compared with those observed at the lumbar spine.…”

Section: Discussionmentioning

confidence: 95%

“…(35)(36)(37)(38) As observed in an earlier 6-month study of the effect of TPT treatment at the lumbar spine, (23) there was a disparity between the changes in regional bone formation and results from studies of the effects of teriparatide on BMD at the spine and hip. (35)(36)(37)(38)(39) The increases in BMD at the hip are relatively modest compared with those observed at the lumbar spine. (35)(36)(37)(38)(39) These results show that large changes in K i , ie, an increase in bone formation at the hip, do not necessarily translate into increases in bone density, at least with TPT.…”

Section: Discussionmentioning

confidence: 95%

18F-fluoride PET as a noninvasive imaging biomarker for determining treatment efficacy of bone active agents at the hip: A prospective, randomized, controlled clinical study

Frost

Moore

Siddique

et al. 2013

Journal of Bone and Mineral Research

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The functional imaging technique of 18 F-fluoride positron emission tomography ( 18 F-PET) allows the noninvasive quantitative assessment of regional bone formation at any skeletal site, including the spine and hip. The aim of this study was to determine if 18 F-PET can be used as an early biomarker of treatment efficacy at the hip. Twenty-seven treatment-naive postmenopausal women with osteopenia were randomized to receive teriparatide and calcium and vitamin D (TPT group, n ¼ 13) or calcium and vitamin D only (control group, n ¼ 14). Subjects in the TPT group were treated with 20 mg/day teriparatide for 12 weeks. 18 F-PET scans of the proximal femur, pelvis, and lumbar spine were performed at baseline and 12 weeks. The plasma clearance of 18 F-fluoride to bone, K i , a validated measurement of bone formation, was measured at four regions of the hip, lumbar spine, and pelvis. A significant increase in K i was observed at all regions of interest (ROIs), including the total hip (þ27%, p ¼ 0.002), femoral neck (þ25%, p ¼ 0.040), hip trabecular ROI (þ21%, p ¼ 0.017), and hip cortical ROI (þ51%, p ¼ 0.001) in the TPT group. Significant increases in K i in response to TPT were also observed at the lumbar spine (þ18%, p ¼ 0.001) and pelvis (þ42%, p ¼ 0.001). No significant changes in K i were observed for the control group. Changes in BMD and bone turnover markers were consistent with previous trials of teriparatide. In conclusion, this is the first study to our knowledge to demonstrate that 18 F-PET can be used as an imaging biomarker for determining treatment efficacy at the hip as early as 12 weeks after initiation of therapy. ß

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Sustained-Release Sodium Fluoride in the Treatment of the Elderly With Established Osteoporosis

Rubin¹,

Pak²,

Adams‐Huet³

et al. 2001

Arch Intern Med

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

Cited by 709 publications

References 21 publications

Differential effects of teriparatide on regional bone formation using 18F-fluoride positron emission tomography

Differential effects of teriparatide on regional bone formation using 18F-fluoride positron emission tomography

18F-fluoride PET as a noninvasive imaging biomarker for determining treatment efficacy of bone active agents at the hip: A prospective, randomized, controlled clinical study

Sustained-Release Sodium Fluoride in the Treatment of the Elderly With Established Osteoporosis

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