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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.

AbstractINTRODUCTION:
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.
AuthorsY 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
JournalOsteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA (Osteoporos Int) Vol. 17 Issue 12 Pg. 1801-7 (Dec 2006) ISSN: 0937-941X [Print] England
PMID17019520 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)
Chemical References
  • Biomarkers
  • Bone Density Conservation Agents
  • Collagen Type I
  • Drug Combinations
  • Hydroxycholecalciferols
  • Maxmarvil
  • Peptides
  • collagen type I trimeric cross-linked peptide
  • Alkaline Phosphatase
  • Calcitriol
  • alfacalcidol
  • Alendronate
Topics
  • Alendronate (adverse effects, therapeutic use)
  • Alkaline Phosphatase (blood)
  • Biomarkers (analysis)
  • Bone Density (physiology)
  • Bone Density Conservation Agents (adverse effects, therapeutic use)
  • Calcitriol (adverse effects, therapeutic use)
  • Collagen Type I (urine)
  • Double-Blind Method
  • Drug Combinations
  • Female
  • Femur (metabolism)
  • Humans
  • Hydroxycholecalciferols (adverse effects, therapeutic use)
  • Korea (epidemiology)
  • Lumbar Vertebrae (metabolism)
  • Middle Aged
  • Osteoporosis, Postmenopausal (drug therapy, epidemiology, metabolism)
  • Peptides (urine)
  • Treatment Outcome

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