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 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.
|
Authors | 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 |
Journal | Osteoporosis 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 |
PMID | 17019520
(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
|