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Severe Vitamin D Deficiency and Low Bone Mass in a Teenager on a Fad Diet
Annual Meeting Abstracts 2011
155
R Lorenc, Specjalistyczny Osrodek Medycyny Wieku Dojrzalego, Warsaw, Poland; A Wang, Amgen Inc., Thousand Oaks, CA, USA; C Libanati, Amgen Inc., Thousand Oaks, CA, USA Background: FREEDOM, the pivotal study establishing significant reductions in new vertebral, non-vertebral and hip fractures with denosumab treatment, also assessed BMD changes over 3 years at the lumbar spine, hip (total hip, femoral neck and trochanter), distal 1/3 radius, and total body by DXA. Methods: All subjects in FREEDOM (n57808, 3906 placebo, 3902 denosumab) had DXA BMD assessed at baseline (BL) and 36 months (mos) at the lumbar spine and at BL and yearly at the hip. Of these, 441 subjects (209 placebo, 232 denosumab) participated in a DXA substudy in which BMD was assessed with greater frequency and at more skeletal sites than in the full study. In these subjects BMD at the spine and hip was assessed at BL and mos 1, 6, 12, 24, and 36. BMD at the 1/3 distal radius and total body was assessed at BL and mos 12, 24, and 36. For the overall study population, a predefined analysis was conducted to determine the percentage of subjects receiving placebo or denosumab who achieved BMD changes from baseline at the lumbar spine and at the total hip of 50.0%, O0.0 to 3.0%, O3.0 to 6%, and O6% after 36 mos. Results: For the overall study population, denosumab significantly increased BMD at the lumbar spine and total hip, attaining mean treatment differences over placebo of 8.8% and 6.4%, respectively, at mo 36 (P!0.0001 for both). Most subjects receiving denosumab had gains in BMD, and those gains were O3% at the spine or total hip in 90% and 74% of subjects, respectively. More than 75% of denosumab subjects had lumbar spine BMD gains O6% (Figure). Women in the DXA substudy had similar characteristics to the overall FREEDOM study population. Their mean (SD) age was 73 (5) years, and their mean (SD) BL lumbar spine and total hip BMD T-scores were -2.8 (0.8) and -1.9 (0.7). At the spine and total hip, where DXA was obtained 1 mo after denosumab administration, BMD was already significantly improved from BL and compared with placebo (all P!0.0001). Denosumab also significantly increased BMD at all other measured skeletal sites at months 12, 24, and 36 (P!0.005). BMD changes in the DXA sub-study at month 36 are summarized in the Table. Conclusions: In postmenopausal women with osteoporosis, denosumab significantly increased BMD across all measured skeletal sites over 36 mos. The increases in BMD occurred early and were robust and consistent at both primarily trabecular and primarily cortical bone sites, and were observed in nearly all subjects. Table Mean (95% CI) Changes in BMD at 36 Months Placebo Denosumab Lumbar spine Total hip Femoral neck Trochanter 1/3 Radius Total body
0.2 -1.1 -0.9 -0.8 -1.2 -0.9
(-0.5, (-1.7, (-1.6, (-1.5, (-1.8, (-1.2,
1.0) -0.6) -0.2) -0.1) -0.7) -0.5)
9.4 4.8 3.9 7.1 2.2 3.2
(8.6, (4.3, (3.2, (6.5, (1.7, (2.9,
10.1) 5.3) 4.6) 7.8) 2.8) 3.5)
P-value* !0.0001 !0.0001 !0.0001 !0.0001 !0.0001 !0.0001
*
P value from baseline and from placebo.
102
Central DXA
PHYSICIAN TIME REQUIRED FOR PREPARATION OF BMD REPORTS USING BONESTATION, A SOFTWARE SYSTEM FOR REPORT PREPARATION AND DATA/ WORKFLOW MANAGEMENT Jessica Wong, Beth Israel Deaconess Medical Center LaTarsha Whittaker, Beth Israel Deaconess Medical Center; Alan Malabanan, Beth Israel Deaconess Medical Center; Harold Rosen, Beth Israel Deaconess Medical Center Background: Given the sharply curtailed reimbursement for densitometry, it is important to maximize efficiencies in densitometry practices. We recently started using BoneStation, a work-flow, data-storage and reporting system, which eliminates the ‘‘mechanical’’ chores in reporting, and we previously reported about savings in space, paper, and technician-time, and improvements in image-clarity. We wondered whether BoneStation also helped reduce the amount of physician-time spent reporting. Methods: We had estimated previously that physician-time required was an average of 10 minutes/study when reporting using paper charts and reporting software from the manufacturer. When we switched to using BoneStation the duration of time between initiating and finalizing the report was tabulated for each of 1137 reports prepared from 4/1/10-5/31/10. Results: Physician time to read a BMD ranged widely, from 0.3-40.6 minutes. MeanSD reading time was 2.413.00 minutes per study, although the time required varied significantly between readers, and was higher for follow-up BMD (2.823.21 minutes), than for initial BMD (1.692.43 minutes, p !0.001). Time-to-read correlated significantly (r50.55, p!0.0001) with the number of prior studies that needed to be reviewed. These measurements, however, are an underestimate of the total amount of physician time we spend reading with BoneStation, because some tasks that the reader does are not captured in these measurements. Certainly more complex reports including FRAX data, and reporting by less experienced readers, will increase the amount of physiciantime required. Conclusions: Studies based in different centers once FRAX is incorporated into densitometry reporting are required before we have a truly representative estimate of physician time required for reporting. So far it seems that time-based reimbursement would give higher reimbursement for repeat than for initial BMDs. However certainly in our center reporting using BoneStation seems to have resulted in significant reductions in the amount of physician-time spent reviewing each BMD.
103
Central DXA
SEVERE VITAMIN D DEFICIENCY AND LOW BONE MASS IN A TEENAGER ON A FAD DIET Sevket Yigit, Connecticut Children’s Medical Center Priya Phulwani, Connecticut Children’s Medical Center; Donna Steben, Connecticut Children’s Medical Center; Elizabeth Estrada, Connecticut Children’s Medical Center A 16 year old male presented with asymptomatic hypocalcemia diagnosed at a primary care visit for an unrelated complaint. He was previously a healthy teenager with normal growth and sexual maturation. His initial total calcium was 6.8 mg/dl (normal:8.4-10.2 mg/dl) with an ionized calcium level of 0.96 mmol/L (normal:1.2-1.35 mmol/L). His PTH was significantly elevated at 257 ng/L and his 25 OH vitamin D level was 5.5 ng/ml. He was strictly on buckwheat diet with no nutritional supplements. He had severe low bone mass at lumbar spine (L14) and total body less head DXA measurement (Table). He was treated with high dose vitamin D and calcium replacement therapy. His calcium and vitamin D levels normalized in three months. His bone mineral density improved significantly in 6 months and normalized in a year (Table). In conclusion, fad diets may cause severe vitamin D deficiency and bone mineral density (BMD) response to appropriate calcium and vitamin D replacement is dramatic.
DXA
Figure. Percent Change in BMD Over 36 Months
Journal of Clinical Densitometry: Assessment of Skeletal Health
Total Body less head BMD (g/cm2) Total Body less head Z-score L1-4 BUD (g/cm2) L1-4 Z-score
Table At diagnosis
In 6 months
In 12 months
0.667 -3.5 0.543 -4.1
0.825 -2.2 0.881 -2.1
0.902 -1.7 1.010 -1.5
Volume 14, 2011
155
R Lorenc, Specjalistyczny Osrodek Medycyny Wieku Dojrzalego, Warsaw, Poland; A Wang, Amgen Inc., Thousand Oaks, CA, USA; C Libanati, Amgen Inc., Thousand Oaks, CA, USA Background: FREEDOM, the pivotal study establishing significant reductions in new vertebral, non-vertebral and hip fractures with denosumab treatment, also assessed BMD changes over 3 years at the lumbar spine, hip (total hip, femoral neck and trochanter), distal 1/3 radius, and total body by DXA. Methods: All subjects in FREEDOM (n57808, 3906 placebo, 3902 denosumab) had DXA BMD assessed at baseline (BL) and 36 months (mos) at the lumbar spine and at BL and yearly at the hip. Of these, 441 subjects (209 placebo, 232 denosumab) participated in a DXA substudy in which BMD was assessed with greater frequency and at more skeletal sites than in the full study. In these subjects BMD at the spine and hip was assessed at BL and mos 1, 6, 12, 24, and 36. BMD at the 1/3 distal radius and total body was assessed at BL and mos 12, 24, and 36. For the overall study population, a predefined analysis was conducted to determine the percentage of subjects receiving placebo or denosumab who achieved BMD changes from baseline at the lumbar spine and at the total hip of 50.0%, O0.0 to 3.0%, O3.0 to 6%, and O6% after 36 mos. Results: For the overall study population, denosumab significantly increased BMD at the lumbar spine and total hip, attaining mean treatment differences over placebo of 8.8% and 6.4%, respectively, at mo 36 (P!0.0001 for both). Most subjects receiving denosumab had gains in BMD, and those gains were O3% at the spine or total hip in 90% and 74% of subjects, respectively. More than 75% of denosumab subjects had lumbar spine BMD gains O6% (Figure). Women in the DXA substudy had similar characteristics to the overall FREEDOM study population. Their mean (SD) age was 73 (5) years, and their mean (SD) BL lumbar spine and total hip BMD T-scores were -2.8 (0.8) and -1.9 (0.7). At the spine and total hip, where DXA was obtained 1 mo after denosumab administration, BMD was already significantly improved from BL and compared with placebo (all P!0.0001). Denosumab also significantly increased BMD at all other measured skeletal sites at months 12, 24, and 36 (P!0.005). BMD changes in the DXA sub-study at month 36 are summarized in the Table. Conclusions: In postmenopausal women with osteoporosis, denosumab significantly increased BMD across all measured skeletal sites over 36 mos. The increases in BMD occurred early and were robust and consistent at both primarily trabecular and primarily cortical bone sites, and were observed in nearly all subjects. Table Mean (95% CI) Changes in BMD at 36 Months Placebo Denosumab Lumbar spine Total hip Femoral neck Trochanter 1/3 Radius Total body
0.2 -1.1 -0.9 -0.8 -1.2 -0.9
(-0.5, (-1.7, (-1.6, (-1.5, (-1.8, (-1.2,
1.0) -0.6) -0.2) -0.1) -0.7) -0.5)
9.4 4.8 3.9 7.1 2.2 3.2
(8.6, (4.3, (3.2, (6.5, (1.7, (2.9,
10.1) 5.3) 4.6) 7.8) 2.8) 3.5)
P-value* !0.0001 !0.0001 !0.0001 !0.0001 !0.0001 !0.0001
*
P value from baseline and from placebo.
102
Central DXA
PHYSICIAN TIME REQUIRED FOR PREPARATION OF BMD REPORTS USING BONESTATION, A SOFTWARE SYSTEM FOR REPORT PREPARATION AND DATA/ WORKFLOW MANAGEMENT Jessica Wong, Beth Israel Deaconess Medical Center LaTarsha Whittaker, Beth Israel Deaconess Medical Center; Alan Malabanan, Beth Israel Deaconess Medical Center; Harold Rosen, Beth Israel Deaconess Medical Center Background: Given the sharply curtailed reimbursement for densitometry, it is important to maximize efficiencies in densitometry practices. We recently started using BoneStation, a work-flow, data-storage and reporting system, which eliminates the ‘‘mechanical’’ chores in reporting, and we previously reported about savings in space, paper, and technician-time, and improvements in image-clarity. We wondered whether BoneStation also helped reduce the amount of physician-time spent reporting. Methods: We had estimated previously that physician-time required was an average of 10 minutes/study when reporting using paper charts and reporting software from the manufacturer. When we switched to using BoneStation the duration of time between initiating and finalizing the report was tabulated for each of 1137 reports prepared from 4/1/10-5/31/10. Results: Physician time to read a BMD ranged widely, from 0.3-40.6 minutes. MeanSD reading time was 2.413.00 minutes per study, although the time required varied significantly between readers, and was higher for follow-up BMD (2.823.21 minutes), than for initial BMD (1.692.43 minutes, p !0.001). Time-to-read correlated significantly (r50.55, p!0.0001) with the number of prior studies that needed to be reviewed. These measurements, however, are an underestimate of the total amount of physician time we spend reading with BoneStation, because some tasks that the reader does are not captured in these measurements. Certainly more complex reports including FRAX data, and reporting by less experienced readers, will increase the amount of physiciantime required. Conclusions: Studies based in different centers once FRAX is incorporated into densitometry reporting are required before we have a truly representative estimate of physician time required for reporting. So far it seems that time-based reimbursement would give higher reimbursement for repeat than for initial BMDs. However certainly in our center reporting using BoneStation seems to have resulted in significant reductions in the amount of physician-time spent reviewing each BMD.
103
Central DXA
SEVERE VITAMIN D DEFICIENCY AND LOW BONE MASS IN A TEENAGER ON A FAD DIET Sevket Yigit, Connecticut Children’s Medical Center Priya Phulwani, Connecticut Children’s Medical Center; Donna Steben, Connecticut Children’s Medical Center; Elizabeth Estrada, Connecticut Children’s Medical Center A 16 year old male presented with asymptomatic hypocalcemia diagnosed at a primary care visit for an unrelated complaint. He was previously a healthy teenager with normal growth and sexual maturation. His initial total calcium was 6.8 mg/dl (normal:8.4-10.2 mg/dl) with an ionized calcium level of 0.96 mmol/L (normal:1.2-1.35 mmol/L). His PTH was significantly elevated at 257 ng/L and his 25 OH vitamin D level was 5.5 ng/ml. He was strictly on buckwheat diet with no nutritional supplements. He had severe low bone mass at lumbar spine (L14) and total body less head DXA measurement (Table). He was treated with high dose vitamin D and calcium replacement therapy. His calcium and vitamin D levels normalized in three months. His bone mineral density improved significantly in 6 months and normalized in a year (Table). In conclusion, fad diets may cause severe vitamin D deficiency and bone mineral density (BMD) response to appropriate calcium and vitamin D replacement is dramatic.
DXA
Figure. Percent Change in BMD Over 36 Months
Journal of Clinical Densitometry: Assessment of Skeletal Health
Total Body less head BMD (g/cm2) Total Body less head Z-score L1-4 BUD (g/cm2) L1-4 Z-score
Table At diagnosis
In 6 months
In 12 months
0.667 -3.5 0.543 -4.1
0.825 -2.2 0.881 -2.1
0.902 -1.7 1.010 -1.5
Volume 14, 2011