A Prospective Analytical Study of the Effects and
Adverse Events of Alendronate (Aldren70®)
Treatment in Thai Postmenopausal Women
Prakit Tienboon MD*,
Nara Jaruwangsanti MD*
Affiliation :
* Department of Orthopaedics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand
Objective : To elucidate the efficacy and adverse events of alendronate (Aldren70®) after 12 months of treatment in 50 to
70 years old postmenopausal women.
Material and Method: The authors observed 50 postmenopausal women who had clinical conditions of osteopenia or
osteoporosis and had never been treated with alendronate acid. Bone mineral density (BMD) of L1-L4, the left hip, and the
left forearm were performed at the initial assessment and after 12 months of treatment. The serum levels of osteocalcin
(OC), procollagen type 1 N-terminal propeptide (P1NP) and beta-crosslaps (beta-CTx) were performed at the baseline and
then after 3 months, 6 months and 12 months of treatment. The data were analyzed using the SPSS software. Paired t-test
was used to compare lumbar spine, hip and forearm before and after treatment.
Results : Treated by using Aldren70 once weekly for one year, the BMD of the lumbar spine increased highly up to 11.26%
(g/cm2) and 25.82% (T-score) from the base line (p<0.001 and p<0.001, respectively). On the other hand, the change in
BMD of the left hip increased 17.54% (g/cm2), 8.2% (T-score), at the left forearm increased 3.96% (g/cm2), 7.62% (T-score)
after 12 months respectively. There was significant increase of BMD between before and after 12 months. The mean values
of bone markers at the 0.05 level before treatment, three months, six months, and 12 months of treatment in osteocalcin
were 0.2813, 0.1242, 0.896, and 0.0889 ng/ml respectively. The P1NP were 36.1762, 19.3894, 14.3084, and 15.1260 ng/ml
respectively. Beta-crosslaps were 0.2813, 0.1242, 0.0896, and 0.0889 ng/ml respectively. Adverse events found in five patients
were the symptoms of stomachache (2, 4%), constipation/diarrhea (1, 2%), palpitation (1, 2%), and muscle/bone pain (1, 2%).
Conclusion : The generic alendronate (Aldren70) in our clinical trial was found to be highly effective at the spine concerning
the bone mass improvement and less at the hip and wrist joints in comparison. All the result figures met the standard efficacy
after 12 months follow-up by increasing bone mass and reducing serum bone markers.
Keywords : Alendronate, Osteoporosis, BMD, Bone Markers, Menopause
All Articles
Download