Effects of a combined alendronate and calcitriol agent (Maxmarvil®) on bone metabolism in Korean postmenopausal women: A multicenter, double-blind, randomized, placebo-controlled study

Y. Rhee, M. Kang, Y. Min, D. Byun, Y. Chung, C. Ahn, K. Baek, J. Mok, D. Kim, D. Kim, H. Kim, Y. Kim, S. Myoung, D. Kim, S. K. Lim

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Abstract

Introduction: A randomized, double-blind, prospective, 24-week clinical trial was performed to evaluate the effects of a combinative agent, Maxmarvil, of calcitriol (0.5 μg) and alendronate (5 mg) on bone metabolism in postmenopausal women. Methods: A total of 217 postmenopausal women with osteoporosis were enrolled; 199 patients were randomly assigned to one of two treatment groups (Maxmarvil group or alfacalcidol group). None of the patients were vitamin-D-deficient, as assessed by serum 25-hydroxyvitamin D (25(OH)D), nor had they received any drugs affecting bone metabolism before enrollment. Bone mineral densities (BMD) of L1-L4 and the femur were measured by dual-energy X-ray absorptiometry (DXA) at the initial assessment and after 6 months of treatment. Serum biochemical assays, including serum calcium, 24-h urinary calcium excretion, and bone turnover markers (both bone-specific alkaline phosphatase [bsALP] and urine N-telopeptide [NTx]), were performed at the baseline and after 3 and 6 months of treatment. Results: In the Maxmarvil group, the BMD of the lumbar spine increased up to 2.42±0.5% from the baseline after 6 months (p<0.05). On the other hand, the change in BMD in the alfacalcidol group was 0.28±0.5% after 6 months. There was no significant difference in femoral BMD between the two groups. The levels of bsALP and NTx were significantly lower in the Maxmarvil group than in the alfacalcidol group (-22.04±3.9% vs. -11.42±2.8% [p<0.05] and -25.46±5.2% vs. 1.24±6.2% [p<0.001], respectively). Interestingly, there was a significantly smaller amount of 24-h urinary calcium in the Maxmarvil group (p<0.05). Conclusions: Our study demonstrates that a combination of calcitriol and alendronate is quite effective in preventing bone loss, with the advantage of lesser hypercalciuric effect of calcitriol in the postmenopausal osteoporotic women.

Original languageEnglish
Pages (from-to)1801-1807
Number of pages7
JournalOsteoporosis International
Volume17
Issue number12
DOIs
Publication statusPublished - 2006 Dec 1

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Alendronate
Calcitriol
Bone Density
Placebos
Bone and Bones
Calcium
Alkaline Phosphatase
Serum
Bone Remodeling
Photon Absorptiometry
Thigh
Vitamin D
Femur
Osteoporosis
Spine
Therapeutics
Maxmarvil
Clinical Trials
Urine
Pharmaceutical Preparations

All Science Journal Classification (ASJC) codes

  • Endocrinology, Diabetes and Metabolism

Cite this

Rhee, Y. ; Kang, M. ; Min, Y. ; Byun, D. ; Chung, Y. ; Ahn, C. ; Baek, K. ; Mok, J. ; Kim, D. ; Kim, D. ; Kim, H. ; Kim, Y. ; Myoung, S. ; Kim, D. ; Lim, S. K. / Effects of a combined alendronate and calcitriol agent (Maxmarvil®) on bone metabolism in Korean postmenopausal women : A multicenter, double-blind, randomized, placebo-controlled study. In: Osteoporosis International. 2006 ; Vol. 17, No. 12. pp. 1801-1807.
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abstract = "Introduction: A randomized, double-blind, prospective, 24-week clinical trial was performed to evaluate the effects of a combinative agent, Maxmarvil, of calcitriol (0.5 μg) and alendronate (5 mg) on bone metabolism in postmenopausal women. Methods: A total of 217 postmenopausal women with osteoporosis were enrolled; 199 patients were randomly assigned to one of two treatment groups (Maxmarvil group or alfacalcidol group). None of the patients were vitamin-D-deficient, as assessed by serum 25-hydroxyvitamin D (25(OH)D), nor had they received any drugs affecting bone metabolism before enrollment. Bone mineral densities (BMD) of L1-L4 and the femur were measured by dual-energy X-ray absorptiometry (DXA) at the initial assessment and after 6 months of treatment. Serum biochemical assays, including serum calcium, 24-h urinary calcium excretion, and bone turnover markers (both bone-specific alkaline phosphatase [bsALP] and urine N-telopeptide [NTx]), were performed at the baseline and after 3 and 6 months of treatment. Results: In the Maxmarvil group, the BMD of the lumbar spine increased up to 2.42±0.5{\%} from the baseline after 6 months (p<0.05). On the other hand, the change in BMD in the alfacalcidol group was 0.28±0.5{\%} after 6 months. There was no significant difference in femoral BMD between the two groups. The levels of bsALP and NTx were significantly lower in the Maxmarvil group than in the alfacalcidol group (-22.04±3.9{\%} vs. -11.42±2.8{\%} [p<0.05] and -25.46±5.2{\%} vs. 1.24±6.2{\%} [p<0.001], respectively). Interestingly, there was a significantly smaller amount of 24-h urinary calcium in the Maxmarvil group (p<0.05). Conclusions: Our study demonstrates that a combination of calcitriol and alendronate is quite effective in preventing bone loss, with the advantage of lesser hypercalciuric effect of calcitriol in the postmenopausal osteoporotic women.",
author = "Y. Rhee and M. Kang and Y. Min and D. Byun and Y. Chung and C. Ahn and K. Baek and J. Mok and D. Kim and D. Kim and H. Kim and Y. Kim and S. Myoung and D. Kim and Lim, {S. K.}",
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Effects of a combined alendronate and calcitriol agent (Maxmarvil®) on bone metabolism in Korean postmenopausal women : A multicenter, double-blind, randomized, placebo-controlled study. / Rhee, Y.; Kang, M.; Min, Y.; Byun, D.; Chung, Y.; Ahn, C.; Baek, K.; Mok, J.; Kim, D.; Kim, D.; Kim, H.; Kim, Y.; Myoung, S.; Kim, D.; Lim, S. K.

In: Osteoporosis International, Vol. 17, No. 12, 01.12.2006, p. 1801-1807.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Effects of a combined alendronate and calcitriol agent (Maxmarvil®) on bone metabolism in Korean postmenopausal women

T2 - A multicenter, double-blind, randomized, placebo-controlled study

AU - Rhee, Y.

AU - Kang, M.

AU - Min, Y.

AU - Byun, D.

AU - Chung, Y.

AU - Ahn, C.

AU - Baek, K.

AU - Mok, J.

AU - Kim, D.

AU - Kim, D.

AU - Kim, H.

AU - Kim, Y.

AU - Myoung, S.

AU - Kim, D.

AU - Lim, S. K.

PY - 2006/12/1

Y1 - 2006/12/1

N2 - Introduction: A randomized, double-blind, prospective, 24-week clinical trial was performed to evaluate the effects of a combinative agent, Maxmarvil, of calcitriol (0.5 μg) and alendronate (5 mg) on bone metabolism in postmenopausal women. Methods: A total of 217 postmenopausal women with osteoporosis were enrolled; 199 patients were randomly assigned to one of two treatment groups (Maxmarvil group or alfacalcidol group). None of the patients were vitamin-D-deficient, as assessed by serum 25-hydroxyvitamin D (25(OH)D), nor had they received any drugs affecting bone metabolism before enrollment. Bone mineral densities (BMD) of L1-L4 and the femur were measured by dual-energy X-ray absorptiometry (DXA) at the initial assessment and after 6 months of treatment. Serum biochemical assays, including serum calcium, 24-h urinary calcium excretion, and bone turnover markers (both bone-specific alkaline phosphatase [bsALP] and urine N-telopeptide [NTx]), were performed at the baseline and after 3 and 6 months of treatment. Results: In the Maxmarvil group, the BMD of the lumbar spine increased up to 2.42±0.5% from the baseline after 6 months (p<0.05). On the other hand, the change in BMD in the alfacalcidol group was 0.28±0.5% after 6 months. There was no significant difference in femoral BMD between the two groups. The levels of bsALP and NTx were significantly lower in the Maxmarvil group than in the alfacalcidol group (-22.04±3.9% vs. -11.42±2.8% [p<0.05] and -25.46±5.2% vs. 1.24±6.2% [p<0.001], respectively). Interestingly, there was a significantly smaller amount of 24-h urinary calcium in the Maxmarvil group (p<0.05). Conclusions: Our study demonstrates that a combination of calcitriol and alendronate is quite effective in preventing bone loss, with the advantage of lesser hypercalciuric effect of calcitriol in the postmenopausal osteoporotic women.

AB - Introduction: A randomized, double-blind, prospective, 24-week clinical trial was performed to evaluate the effects of a combinative agent, Maxmarvil, of calcitriol (0.5 μg) and alendronate (5 mg) on bone metabolism in postmenopausal women. Methods: A total of 217 postmenopausal women with osteoporosis were enrolled; 199 patients were randomly assigned to one of two treatment groups (Maxmarvil group or alfacalcidol group). None of the patients were vitamin-D-deficient, as assessed by serum 25-hydroxyvitamin D (25(OH)D), nor had they received any drugs affecting bone metabolism before enrollment. Bone mineral densities (BMD) of L1-L4 and the femur were measured by dual-energy X-ray absorptiometry (DXA) at the initial assessment and after 6 months of treatment. Serum biochemical assays, including serum calcium, 24-h urinary calcium excretion, and bone turnover markers (both bone-specific alkaline phosphatase [bsALP] and urine N-telopeptide [NTx]), were performed at the baseline and after 3 and 6 months of treatment. Results: In the Maxmarvil group, the BMD of the lumbar spine increased up to 2.42±0.5% from the baseline after 6 months (p<0.05). On the other hand, the change in BMD in the alfacalcidol group was 0.28±0.5% after 6 months. There was no significant difference in femoral BMD between the two groups. The levels of bsALP and NTx were significantly lower in the Maxmarvil group than in the alfacalcidol group (-22.04±3.9% vs. -11.42±2.8% [p<0.05] and -25.46±5.2% vs. 1.24±6.2% [p<0.001], respectively). Interestingly, there was a significantly smaller amount of 24-h urinary calcium in the Maxmarvil group (p<0.05). Conclusions: Our study demonstrates that a combination of calcitriol and alendronate is quite effective in preventing bone loss, with the advantage of lesser hypercalciuric effect of calcitriol in the postmenopausal osteoporotic women.

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