Effects of a combined alendronate and calcitriol agent (Maxmarvil) on bone metabolism in Korean postmenopausal women: a multicenter, double-blind, randomized, placebo-controlled study.
BACKGROUND
A randomized, double-blind, prospective, 24-week clinical trial was performed to evaluate the effects of a combinative agent, Maxmarvil, of calcitriol (0.5 mug) 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.
Rhee
Y
Y
Department of Internal Medicine, Endocrine Research Institute, College of Medicine, Yonsei University, #134 Shinchon-Dong, Seodaemun-Gu, Seoul 120-752, South Korea.
Kang
M
M
Min
Y
Y
Byun
D
D
Chung
Y
Y
Ahn
C
C
Baek
K
K
Mok
J
J
Kim
D
D
Kim
D
D
Kim
H
H
Kim
Y
Y
Myoung
S
S
Kim
D
D
Lim
S-K
SK
D019386:Alendronate / Q000009:adverse effects / Q000627:therapeutic use*; D000469:Alkaline Phosphatase / Q000097:blood; D015415:Biomarkers / Q000032:analysis; D015519:Bone Density / Q000502:physiology; D050071:Bone Density Conservation Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002117:Calcitriol / Q000009:adverse effects / Q000627:therapeutic use*; D024042:Collagen Type I / Q000652:urine; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D005269:Femur / Q000378:metabolism; D006801:Humans; D006887:Hydroxycholecalciferols / Q000009:adverse effects / Q000627:therapeutic use; D007723:Korea / Q000453:epidemiology; D008159:Lumbar Vertebrae / Q000378:metabolism; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000188:drug therapy* / Q000453:epidemiology / Q000378:metabolism; D010455:Peptides / Q000652:urine; D016896:Treatment Outcome
D015415:Biomarkers; D050071:Bone Density Conservation Agents; D024042:Collagen Type I; D004338:Drug Combinations; D006887:Hydroxycholecalciferols; C517862:Maxmarvil; D010455:Peptides; C052929:collagen type I trimeric cross-linked peptide; D000469:Alkaline Phosphatase; D002117:Calcitriol; C008088:alfacalcidol; D019386:Alendronate