- Email: [email protected]
Changes in calcium and vitamin d supplement intake during a one-year falls intervention study
220
Abstracts
type 1 N-terminal propeptide (P1NP), serum osteocalcin, and serum bone-specific alkaline phosphatase (BSAP) in bisphosphonate-na€ıve women with postmenopausal osteoporosis (PMO) given 150-mg monthly oral ibandronate. sCTX levels declined rapidly to approximately 70% when measured 7 days after ibandronate doses at baseline and Month 4. sCTX levels measured immediately before ibandronate doses at baseline, 1, 2, 3 and 6 months declined gradually to 55% at Month 6. There was a cycle of offset and onset in sCTX noted between maximum suppression observed 7 days after ibandronate dose (square symbols) and levels seen just before ibandronate dose (diamond symbols). Levels of bone formation markers did not vary concordantly with the levels of sCTX and only declined gradually over time (levels at Month 6; P1NP 58%, osteocalcin 42%, and BSAP 35%). Most adverse events (428/578) were considered by the investigators to be unrelated or remotely related to the study medication. Overall, 71 (23.1%) patients had a total of 123 AEs that were possibly related and 19 (6.2%) patients had a total of 27 AEs that were probably related to study medication. Seventeen (5.5%) patients experienced a total of 23 serious AEs, and 24 (7.8%) patients were withdrawn from the study due to AEs. Bisphosphonate-na€ıve women with PMO treated with monthly ibandronate achieved a rapid reduction in sCTX within 7 days, which was sustained over 6months. Once-monthly oral ibandronate was generally well tolerated.
A total of 967 women received monthly ibandronate and 8662 women received weekly BPs. Of patients receiving monthly ibandronate, 40.7% were osteoporosis medication-na€ıve, 13.1% were BP-na€ıve, and 46.1% had switched from another BP dosing regimen. At 9 months, 47.7% of patients receiving monthly ibandronate were persistent and 35.4% of patients receiving weekly BPs were persistent (P ! 0.0001). After adjusting for confounding factors, monthly users were 38% less likely to discontinue therapy versus weekly users (hazard ratio 5 0.620, 95% CI: 0.563e0.683, P ! 0.0001). The 9-month results of this early postlaunch study suggest that women receiving monthly ibandronate are 38% more likely to continue their osteoporosis therapy compared to women in the weekly BP cohort. These data suggest an improvement in patient persistence with once-monthly therapy.
Poster Number 177
Prevention and Treatment of Osteoporosis
CHANGES IN CALCIUM AND VITAMIN D SUPPLEMENT INTAKE DURING A ONE-YEAR FALLS INTERVENTION STUDY KE Hansen, MD, University of Wisconsin J Mahoney, University of Wisconsin Older patients who fall may be asked to increase intake of vitamin D and/or calcium to decrease falls risk. We enrolled 500 older subjects in a prospective falls intervention study. During the one-year study, we determined subjects rate of increasing intake and meeting the adequate intake for calcium (O1200 mg) and vitamin D (O400 IU for ages 51-70, O600 IU for ages O70 years) through use of supplements. We analyzed participants change in calcium and vitamin D supplement intake over the one-year fall study and examined patient variables potentially associated with intake of these nutrients. Participants significantly increased the likelihood of meeting the age-specific AI for vitamin D (28% at baseline, 37% at one year, p 5 0.004). Subjects who increased vitamin D intake were more likely to be randomized to active treatment (65% versus 45%, p ! 0.001), report exercise within the past two weeks (63% versus 51%, p 5 0.04) and report increased intake of calcium during the study (p ! 0.001). Through supplements, the calcium AI was met by 18% at baseline and 20% one year (p 5 0.5). The subset of subjects reporting increased calcium intake (n 5 108) were more likely to be randomized to active falls intervention strategies (44% versus 62%, p 5 0.001). During a one year falls study, participants assigned to active falls interventions and those reporting regular exercise and increases in calcium intake were more likely to increase vitamin D intake via supplements. Simple strategies to improve intake of calcium and vitamin D supplements are needed to enhance adherence to treatment recommendations.
Poster Number 176
Prevention and Treatment of Osteoporosis
WOMEN ARE MORE PERSISTENT WITH MONTHLY IBANDRONATE VERSUS WEEKLY BISPHOSPHONATES SL Silverman, MD, Cedars-Sinai/UCLA, Beverly Hills, CA CH Chesnut III, Osteoporosis Research Group, University of Washington, Seattle, WA; C Harley, i3 Innovus, Eden Prairie, MN; CE Barr, Roche, Nutley, NJ; S Poston, GlaxoSmithKline, Collegeville, PA In this study, we evaluated osteoporosis medication persistence at 9 months among patients newly prescribed monthly ibandronate versus weekly bisphosphonates (BPs). A retrospective health plan administrative claims database, covering approximately 16 million lives and accessed through i3 Innovus, was used to collect data from female patients e45 years of age who filled new prescriptions for monthly ibandronate or a weekly BP (risedronate or alendronate) from April 1, 2005 through September 30, 2005. Persistence was measured as the proportion of patients who stayed on therapy with no refill gaps exceeding defined grace periods. A Cox proportional hazards model was used to control for the effects of confounding factors commonly observed in such non-randomized, observational database studies.
Journal of Clinical Densitometry
Poster Number 179
Prevention and Treatment of Osteoporosis
SINGLE INFUSION OF ZOLEDRONIC ACID 5 MG PROVIDES SUSTAINED BENEFITS IN BONE MINERAL DENSITY AND BIOMARKERS AT 12 MONTHS IN POSTMENOPAUSAL WOMEN WITH LOW BONE MINERAL DENSITY AND PRIOR ALENDRONATE THERAPY Michael McClung, MD, Director, Oregon Osteoporosis Center Molly Omizo, Oregon Osteoporosis Center; Jerome Minkoff, Kaiser Permanente; Darrell Fiske, Radiant Research; Audrey Kriegman Emily Beamer and Wenchun Zhou This multicenter, randomized, double-blind, double-dummy non-inferiority study evaluated safety and efficacy of a single dose of IV zoledronic acid (ZOL) 5 mg vs oral alendronate (ALN) 70 mg weekly in postmenopausal women with low BMD previously treated with ALN. Postmenopausal women who were receiving oral ALN for at least 1 year prior to randomization and with lumbar spine or femoral neck T-score d 2.0 prior to initiation of ALN were randomized to one 15-min infusion of ZOL 5 mg + 52 weeks of oral placebo (n 5 113) or one infusion of placebo + 52 weeks of oral ALN 70 mg (n 5 112). Endpoints included percent change
Volume 10, 2007
Abstracts
type 1 N-terminal propeptide (P1NP), serum osteocalcin, and serum bone-specific alkaline phosphatase (BSAP) in bisphosphonate-na€ıve women with postmenopausal osteoporosis (PMO) given 150-mg monthly oral ibandronate. sCTX levels declined rapidly to approximately 70% when measured 7 days after ibandronate doses at baseline and Month 4. sCTX levels measured immediately before ibandronate doses at baseline, 1, 2, 3 and 6 months declined gradually to 55% at Month 6. There was a cycle of offset and onset in sCTX noted between maximum suppression observed 7 days after ibandronate dose (square symbols) and levels seen just before ibandronate dose (diamond symbols). Levels of bone formation markers did not vary concordantly with the levels of sCTX and only declined gradually over time (levels at Month 6; P1NP 58%, osteocalcin 42%, and BSAP 35%). Most adverse events (428/578) were considered by the investigators to be unrelated or remotely related to the study medication. Overall, 71 (23.1%) patients had a total of 123 AEs that were possibly related and 19 (6.2%) patients had a total of 27 AEs that were probably related to study medication. Seventeen (5.5%) patients experienced a total of 23 serious AEs, and 24 (7.8%) patients were withdrawn from the study due to AEs. Bisphosphonate-na€ıve women with PMO treated with monthly ibandronate achieved a rapid reduction in sCTX within 7 days, which was sustained over 6months. Once-monthly oral ibandronate was generally well tolerated.
A total of 967 women received monthly ibandronate and 8662 women received weekly BPs. Of patients receiving monthly ibandronate, 40.7% were osteoporosis medication-na€ıve, 13.1% were BP-na€ıve, and 46.1% had switched from another BP dosing regimen. At 9 months, 47.7% of patients receiving monthly ibandronate were persistent and 35.4% of patients receiving weekly BPs were persistent (P ! 0.0001). After adjusting for confounding factors, monthly users were 38% less likely to discontinue therapy versus weekly users (hazard ratio 5 0.620, 95% CI: 0.563e0.683, P ! 0.0001). The 9-month results of this early postlaunch study suggest that women receiving monthly ibandronate are 38% more likely to continue their osteoporosis therapy compared to women in the weekly BP cohort. These data suggest an improvement in patient persistence with once-monthly therapy.
Poster Number 177
Prevention and Treatment of Osteoporosis
CHANGES IN CALCIUM AND VITAMIN D SUPPLEMENT INTAKE DURING A ONE-YEAR FALLS INTERVENTION STUDY KE Hansen, MD, University of Wisconsin J Mahoney, University of Wisconsin Older patients who fall may be asked to increase intake of vitamin D and/or calcium to decrease falls risk. We enrolled 500 older subjects in a prospective falls intervention study. During the one-year study, we determined subjects rate of increasing intake and meeting the adequate intake for calcium (O1200 mg) and vitamin D (O400 IU for ages 51-70, O600 IU for ages O70 years) through use of supplements. We analyzed participants change in calcium and vitamin D supplement intake over the one-year fall study and examined patient variables potentially associated with intake of these nutrients. Participants significantly increased the likelihood of meeting the age-specific AI for vitamin D (28% at baseline, 37% at one year, p 5 0.004). Subjects who increased vitamin D intake were more likely to be randomized to active treatment (65% versus 45%, p ! 0.001), report exercise within the past two weeks (63% versus 51%, p 5 0.04) and report increased intake of calcium during the study (p ! 0.001). Through supplements, the calcium AI was met by 18% at baseline and 20% one year (p 5 0.5). The subset of subjects reporting increased calcium intake (n 5 108) were more likely to be randomized to active falls intervention strategies (44% versus 62%, p 5 0.001). During a one year falls study, participants assigned to active falls interventions and those reporting regular exercise and increases in calcium intake were more likely to increase vitamin D intake via supplements. Simple strategies to improve intake of calcium and vitamin D supplements are needed to enhance adherence to treatment recommendations.
Poster Number 176
Prevention and Treatment of Osteoporosis
WOMEN ARE MORE PERSISTENT WITH MONTHLY IBANDRONATE VERSUS WEEKLY BISPHOSPHONATES SL Silverman, MD, Cedars-Sinai/UCLA, Beverly Hills, CA CH Chesnut III, Osteoporosis Research Group, University of Washington, Seattle, WA; C Harley, i3 Innovus, Eden Prairie, MN; CE Barr, Roche, Nutley, NJ; S Poston, GlaxoSmithKline, Collegeville, PA In this study, we evaluated osteoporosis medication persistence at 9 months among patients newly prescribed monthly ibandronate versus weekly bisphosphonates (BPs). A retrospective health plan administrative claims database, covering approximately 16 million lives and accessed through i3 Innovus, was used to collect data from female patients e45 years of age who filled new prescriptions for monthly ibandronate or a weekly BP (risedronate or alendronate) from April 1, 2005 through September 30, 2005. Persistence was measured as the proportion of patients who stayed on therapy with no refill gaps exceeding defined grace periods. A Cox proportional hazards model was used to control for the effects of confounding factors commonly observed in such non-randomized, observational database studies.
Journal of Clinical Densitometry
Poster Number 179
Prevention and Treatment of Osteoporosis
SINGLE INFUSION OF ZOLEDRONIC ACID 5 MG PROVIDES SUSTAINED BENEFITS IN BONE MINERAL DENSITY AND BIOMARKERS AT 12 MONTHS IN POSTMENOPAUSAL WOMEN WITH LOW BONE MINERAL DENSITY AND PRIOR ALENDRONATE THERAPY Michael McClung, MD, Director, Oregon Osteoporosis Center Molly Omizo, Oregon Osteoporosis Center; Jerome Minkoff, Kaiser Permanente; Darrell Fiske, Radiant Research; Audrey Kriegman Emily Beamer and Wenchun Zhou This multicenter, randomized, double-blind, double-dummy non-inferiority study evaluated safety and efficacy of a single dose of IV zoledronic acid (ZOL) 5 mg vs oral alendronate (ALN) 70 mg weekly in postmenopausal women with low BMD previously treated with ALN. Postmenopausal women who were receiving oral ALN for at least 1 year prior to randomization and with lumbar spine or femoral neck T-score d 2.0 prior to initiation of ALN were randomized to one 15-min infusion of ZOL 5 mg + 52 weeks of oral placebo (n 5 113) or one infusion of placebo + 52 weeks of oral ALN 70 mg (n 5 112). Endpoints included percent change
Volume 10, 2007